GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 79-06-1 |
| Chemical Name | Acrylamide |
| Substance ID | H29-B-011 |
| Classification year (FY) | FY2017 |
| Ministry who conducted the classification | Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE) |
| New/Revised | Revised |
| Classification result in other fiscal year | FY2006 |
| Download of Excel format | Excel file |
REFERENCE INFORMATION
| Item | Information |
|---|---|
| Guidance used for the classification (External link) | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| UN GHS document (External link) | UN GHS document |
| Definitions/Abbreviations (Excel file) | Definitions/Abbreviations |
| Model Label by MHLW (External link) | MHLW Website (in Japanese Only) |
| Model SDS by MHLW (External link) | MHLW Website (in Japanese Only) |
| OECD/eChemPortal (External link) | eChemPortal |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Explosives | Not applicable |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. |
| 2 | Flammable gases (including chemically unstable gases) | Not applicable |
- |
- | - | Solid (GHS definition). |
| 3 | Aerosols | Not applicable |
- |
- | - | Not aerosol products. |
| 4 | Oxidizing gases | Not applicable |
- |
- | - | Solid (GHS definition). |
| 5 | Gases under pressure | Not applicable |
- |
- | - | Solid (GHS definition). |
| 6 | Flammable liquids | Not applicable |
- |
- | - | Solid (GHS definition). |
| 7 | Flammable solids | Classification not possible |
- |
- | - | It is described that it is combustible (ICSC (J) (2013)), but the classification is not possible due to no data. |
| 8 | Self-reactive substances and mixtures | Classification not possible |
- |
- | - | There is a chemical group associated with self-reactive properties (ethylene group) in the molecule, but the classification is not possible due to no data. |
| 9 | Pyrophoric liquids | Not applicable |
- |
- | - | Solid (GHS definition). |
| 10 | Pyrophoric solids | Not classified |
- |
- | - | It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 424 deg C (GESTIS (Access on June 2017)). |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | Test methods applicable to solid (melting point <= 140 deg C) substances are not available. |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | Not applicable |
- |
- | - | The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). |
| 13 | Oxidizing liquids | Not applicable |
- |
- | - | Solid (GHS definition). |
| 14 | Oxidizing solids | Not applicable |
- |
- | - | The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen. |
| 15 | Organic peroxides | Not applicable |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | Test methods applicable to solid substances are not available. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Category 3 |
 Danger |
H301 |
P301+P310
P264 P270 P321 P330 P405 P501 |
As LD50 values for rats, seven data of 124 mg/kg (EHC 49 (1985)), 175 mg/kg (EU-RAR (2002)), 180 mg/kg (ATSDR (2012)), 203 mg/kg (EU-RAR (2002)), 294 mg/kg, 316 mg/kg, and 413 mg/kg are reported (all referred to ATSDR (2012)). Five cases of them correspond to Category 3, and two cases correspond to Category 4. It was classified in Category 3 by adopting the category with the larger number of cases and higher hazard. |
| 1 | Acute toxicity (Dermal) | Category 3 |
Danger |
H311 |
P302+P352
P361+P364 P280 P312 P321 P405 P501 |
As LD50 values for rats, two data of 252 mg/kg (ATSDR (2012)) and 400 mg/kg (EHC 49 (1985)) are reported, and both correspond to Category 3. As LD50 values for rabbits, two data of 941 mg/kg (ATSDR (2012)) and 1,148 mg/kg (EU-RAR (2002)) are reported, one case corresponds to Category 3, and the other corresponds to Category 4. It was classified in Category 3 by adopting the category with the larger number of cases and higher hazard. |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 2 | Skin corrosion/irritation | Not classified |
- |
- | - | Since it is considered to be slightly irritating from the human cases (EU-RAR (2002), ACGIH (7th, 2005)) and the skin irritation test with rabbits (EU-RAR (2002)), it was classified as "Not classified" (Category 3 in UN GHS classification). Besides, this substance was classified as "Skin Irrit. 2" in EU CLP classification (ECHA CL Inventory (Access on May 2017)). |
| 3 | Serious eye damage/eye irritation | Category 2A |
 Warning |
H319 |
P305+P351+P338
P337+P313 P264 P280 |
Based on a report that in an eye irritation test with rabbits, corneal opacity, conjunctival redness, and conjunctival edema were observed and disappeared in a 21-day observation period (EU-RAR (2002)), it was classified in Category 2A. Besides, this substance was classified as "Eye Irrit. 2" in EU CLP classification (ECHA CL Inventory (Access on May 2017)). |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 4 | Skin sensitization | Category 1 |
Warning |
H317 |
P302+P352
P333+P313 P362+P364 P261 P272 P280 P321 P501 |
There are multiple reports of contact dermatitis attributed to this substance in humans (ACGIH (7th, 2005)), and it is reported that two skin sensitization tests with guinea pigs were positive (EU-RAR (2002)). Based on the above reports and the classification as occupational skin sensitizers Group 2 by Japan Society For Occupational Health (JSOH), it was classified in Category 1. Besides, this substance was classified as "Skin Sens. 1" in EU CLP classification (ECHA CL Inventory (Access on May 2017)). |
| 5 | Germ cell mutagenicity | Category 1B |
 Danger |
H340 |
P308+P313
P201 P202 P280 P405 P501 |
As for in vivo, there are positive results in dominant lethal tests with rats and mice, a reciprocal translocation test, a specific locus test, a chromosomal aberration test and a micronucleus test with mouse germ cells, a chromosomal aberration test and a micronucleus test with bone marrow cells of rats and mice, a gene mutation test with transgenic rats and mice, etc. (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), ATSDR (2012)). As for in vitro, there are negative results in bacterial reverse mutation tests, and in tests with mammalian cultured cells, it was positive in mouse lymphoma test and gave positive or negative results in gene mutation tests and a positive result in a chromosome aberration test (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). In addition, it is also described in EU-RAR (2002) and DFGOT Vol. 25 (2009) that this substance is clearly genotoxic to somatic cells and germ cells in vivo, moreover, it induces in vivo heritable mutations in experimental animals. From the above, it was classified in Category 1B according to the GHS classification guidance for the Japanese government. |
| 6 | Carcinogenicity | Category 1B |
Danger |
H350 |
P308+P313
P201 P202 P280 P405 P501 |
Evidence of carcinogenicity in humans is extremely limited. As for experimental animals, in two tests in which rats were dosed by drinking water for a long time, an increase in a combined incidence of follicular epithelial cell adenoma or carcinoma in the thyroid was found in females and males, and scrotal mesothelioma in males and fibroadenoma in the mammary glands in females were observed. In addition, there is sufficient evidence of carcinogenicity in experimental animals, such as an increase in skin tumors also reported in mouse initiation and promotion tests (NTP RoC (14th, 2016), IRIS (2010)). As for classification by other organizations, IARC classified it in Group 2A (IARC 60 (1994)), EPA as L (IRIS (2010)), NTP as R (NTP RoC (14th, 2016)), ACGIH in A3 (ACGIH (7th, 2005)), Japan Society For Occupational Health (JSOH) in Group 2A (Recommendation of Occupational Exposure Limits (2016)), and EU in Carc 1B (ECHA CL Inventory (Access on May 2016)). From the above, since all of the classification results of carcinogenicity by other organizations correspond to Category 1B except for the ACGIH's, it was classified in Category 1B for this hazard class. |
| 7 | Reproductive toxicity | Category 1B |
Danger |
H360 |
P308+P313
P201 P202 P280 P405 P501 |
In dominant lethal tests in which male rats were given this substance by gavage for ten weeks or six months and mated with untreated females, an increase in the embryo loss after implantation at 5.0 mg/kg/day in the former case and an increase in the number of dead embryos at 6 mg/kg/day in the latter case were observed (OEL Documentations (Japan Society For Occupational Health (JSOH), 2014), DFGOT Vol. 25 (2009)). In addition, in tests in which male mice were dosed by drinking water for four weeks, or male rats were dosed by gavage for five days or by drinking water for ten weeks, and mated with untreated females, a decrease in the pregnancy rate (male fertility rate) was observed, and in the drinking water tests with mice and rats, a decrease in the sperm counts was also detected (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), ACGIH (7th, 2005), DFGOT Vol. 25 (2009)). On the other hand, in the developmental toxicity tests with pregnant mice or pregnant rats dosed by gavage during the organogenesis period, at doses where maternal toxicity (decreased body weight gain) occurred, no abnormality in fetuses was observed in rats, and only decreased body weight of fetuses and an increase in extra ribs were observed in mice (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), ACGIH (7th, 2005), DFGOT Vol. 25 (2009)). However, in a developmental toxicity test with pregnant rats dosed by gavage from the organogenesis period to postnatal day 10, an increase in postnatal mortality of pups was observed at a dose where decreased body weight gain and a neurological symptom were observed in maternal animals (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), ACGIH (7th, 2005), DFGOT Vol. 25 (2009)). As for classification by other organizations, Japan Society For Occupational Health (JSOH) classified it as "Reproductive toxicants Group 2" (OEL Documentations (2014)), and EU as "Repr. 2" (ECHA CL Inventory (Access on May 2017)). From the above, this substance was positive in the dominant lethal tests, and a decrease in male fertility (insemination rate) occurred at the doses at which general toxic effect on male animals was not observed or equivocal. Therefore, it was judged as reasonable to classify it in Category 1B. |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (nervous system) |
Danger |
H370 |
P308+P311
P260 P264 P270 P321 P405 P501 |
As for humans, there is a report on one case of a woman (body weight 48 kg, estimated intake amount 375 mg/kg) who ingested about 18 g of this substance in a suicide attempt showed hallucinations, hypotension, gastrointestinal tract bleeding, peripheral nerve disorder, hepatic disorders and seizures due to them, and two months after ingestion, peripheral neuropathy was still observed (EU-RAR (2002), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), ATSDR (2012)). As for experimental animals, there is a report that in a single oral dose test with rats, motor incoordination, hindlimb muscular dysfunction, hyperreflexia, persistent and clonic convulsions, and tremors were observed at 250 mg/kg/day corresponding to Category 1 (EU-RAR (2002), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Risk Assessment Report (Food Safety Commission of Japan, 2016)). In addition, there is a report that in a single dermal administration test with rabbits, tremors and motor incoordination were observed at 784-1,568 mg/kg corresponding to Category 1-Category 2 (ATSDR (2012)). From the above information, the nervous system is thought to be the target organ of this substance. Since the information in humans is only one case, it was not adopted as evidence of the classification, however, it was classified in Category 1 (nervous system) because the effects on experimental animals were observed at doses corresponding to Category 1. Besides, there is a report that in a single oral dose test with mice, at 100-150 mg/kg corresponding to Category 1, vacuolation and enlargement of the nuclei of the spermatids in the testes of surviving animals were observed from one day after administration, however, they recovered on days 7-10 (IRIS Tox Review (2010), EU-RAR (2002)). Though in the previous classification, the testis was also adopted as the target organ based on this information, it was excluded from the target organs due to a reversible effect this time. Therefore, the classification result was changed. |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (nervous system, eye, haemal system, genetic organs (men)) |
Danger |
H372 |
P260
P264 P270 P314 P501 |
As for humans, chronic neuropathy such as polyneuropathy, and contact dermatitis are pointed out as effects of occupational exposure (Environmental Risk Assessment for Chemical Substances Vol.1 (Ministry of the Environment, 2002)). In addition, in the case of intake from contaminated well water, gait disturbance, memory impairment, hallucinations, speech impairment, numbness of limbs, abnormal perspiration of limbs, and dysgeusia, etc. are reported (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). As for experimental animals, in a 90-day repeated dose toxicity test with rats dosed by drinking water, minute changes in the peripheral nerve (invagination of the axon sheath on electron microscopy) at or above 1 mg/kg/day within the guidance value range for Category 1, peripheral nerve injuries (axonal degeneration and demyelination) at or above 5 mg/kg/day within the guidance value range for Category 1, and toe deformation, frailty of hindlimbs, incoordination, spinal cord injury, skeletal muscle atrophy, testicular atrophy, decreased erythrocyte parameters (erythrocyte count, hematocrit value, hemoglobin concentration) at 20 mg/kg/day within the guidance value range for Category 2 were reported (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), IRIS Tox. Review (2010)). Among the series of tests by NTP, in a 90-day repeated dose toxicity test with rats dosed by drinking water, testicular epithelium cell degeneration of the testes was observed at or above 50 ppm (converted guidance value: 6.25 mg/kg/day) within the guidance value range for Category 1, paralysis of hindlimbs was observed at or above 100 ppm (converted guidance value: 12.5 mg/kg/day) within the guidance value range for Category 2, axon degeneration of the sciatic nerve, degeneration of Schwann cells, degeneration of lumbar spinal cord axons, atrophy in skeletal muscle of hindlimbs, dilation of the bladder, hemosiderin deposition in the spleen, and an increase in erythrocyte precursors in the bone marrow were observed at 250 ppm (converted guidance value: 31.25 mg/kg/day) within the guidance value range for Category 2. In a 90-day repeated dose toxicity test with rats dosed by feeding, testicular epithelium cell degeneration in the testis at or above 7.4 mg/kg diet (converted guidance value: 0.37 mg/kg/day) within the guidance value range for Category 1, axon degeneration of the sciatic nerve and degeneration of Schwann cells at or above 74 mg/kg diet (converted guidance value: 3.7 mg/kg/day) within the guidance value range for Category 1, and paralysis of hindlimbs, degeneration of lumbar spinal cord axons, atrophy in skeletal muscle of hindlimbs, dilation of the bladder, hemosiderin deposition in the spleen, and degeneration of sperm cells at 185 mg/kg diet (converted guidance value: 9.25 mg/kg/day) within the guidance value range for Category 1 were observed. In a 2-year carcinogenicity test with rats dosed by drinking water, dilatation of ducts in the preputial glands at or above 12.5 ppm (male: 0.66 mg/kg/day, female: 0.88 mg/kg/day) within the guidance value range for Category 1, retinal degeneration and bone marrow hyperplasia at or above 25 ppm (male: 1.32 mg/kg/day, female: 1.84 mg/kg/day) within the guidance value range for Category 1, and axon degeneration of the sciatic nerve, hypertrophy and cytoplasmic vacuolation of the adrenal cortex, and hematopoietic cell proliferation in the spleen at 50 ppm (male: 2.71 mg/kg/day, female: 4.02 mg/kg/day) within the guidance value range for Category 1 were observed (NTP TR575 (2012)). NTP carried out a test also in mice, and in a 90-day administration test by drinking water or feeding, effects on the nervous system and male genetic organs were observed similarly to the tests in rats, however, they were found at doses within the guidance value range for Category 2, and rats were affected more strongly. Other than these, in a 13-week repeated dose toxicity test with monkeys dosed by gavage, axon degeneration of the peripheral nerve due to myelin degeneration and axon degeneration of the optic tract nerve were observed at 10 mg/kg/day within the guidance value range for Category 1 (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). From the above, effects on the nervous system, eye, male genetic organs, haemal system were observed, and muscle atrophy, etc. which is considered to be associated with effects on the nervous system was observed. In the previous classification, the eyes and haemal system were not adopted as the target organs. As for effects on the eyes, they were adopted as the target organ because retinal degeneration was observed in addition to axon degeneration of the optic tract nerve. Regarding the haemal system, hematological examination was not carried out except for a report of decreases in erythrocyte parameters, however, in the tests by NTP, there are reports of hemosiderin deposition in the spleen and an increase in erythrocyte precursors in the bone marrow, therefore, the haemal system was adopted as the target organ. Therefore, it was classified in Category 1 (nervous system, eye, haemal system, genetic organs (men)). |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (Acute) | Category 3 |
- |
H402 |
P273
P501 |
From 72-hour EC50 (growth inhibition) = 33.8 mg/L for algae (Pseudokirchneriella subcapitata) (Initial Risk Assessment (NITE, CERI, NEDO, 2007), NICNAS PEC: 2002), it was classified in Category 3. |
| 11 | Hazardous to the aquatic environment (Long-term) | Not classified |
- |
- | - | Due to being rapidly degradable (readily biodegradable, average degradation rate by BOD: 70% (J-CHECK, 1999)), no bioaccumulation (LogKow: -1.65 (Environmental Risk Assessment for Chemical Substances vol. 1 (Ministry of the Environment, 2002))), 28-day NOEC (survival rate) = 2.04 mg/L for crustacea (Mysidopsis bahia) (OECD SIDS:2001, Initial Risk Assessment (NITE, CERI, NEDO, 2007)), and 72-hour NOEC (growth inhibition) = 16 mg/L for algae (Pseudokirchneriella subcapitata) (OECD SIDS: 2001, NICNAS PEC: 2002, EU RAR: 2002, Initial Risk Assessment (NITE, CERI, NEDO, 2007)), it was classified as "Not classified." |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
|
* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted. * Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement. Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file. * Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users. * This is a provisional English translation of classification results and is subject to revision without notice. * The responsibility for any resulting GHS labelling and SDS referenced from this site is with users. * Codes assigned to each of the hazard statements and codes for each of the precautionary statement are based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations. |