GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 94-75-7 |
| Chemical Name | 2,4-Dichlorophenoxyacetic acid |
| Substance ID | H28-B-031, C-042B |
| Classification year (FY) | FY2016 |
| 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 | Not classified |
- |
- | - | It is not combustible (ICSC(J) (2005)). |
| 8 | Self-reactive substances and mixtures | Not applicable |
- |
- | - | There are no chemical groups present in the molecule associated with explosive or self-reactive properties. |
| 9 | Pyrophoric liquids | Not applicable |
- |
- | - | Solid (GHS definition). |
| 10 | Pyrophoric solids | Not classified |
- |
- | - | It is not combustible (ICSC(J) (2005)). |
| 11 | Self-heating substances and mixtures | Not classified |
- |
- | - | It is not combustible (ICSC(J) (2005)). |
| 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 and chlorine which are chemically bonded only to carbon. |
| 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. Besides, there is the information that it attacks metals (ICSC (2005)). |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Category 4 |
 Warning |
H302 |
P301+P312
P264 P270 P330 P501 |
Based on reports of LD50 values for rats of 443 mg/kg and 699 mg/kg (JMPR (1996)), this substance was classified in Category 4. Besides, for this substance, based on expert judgment, JMPR was preferentially adopted as the information source of LD50 values. |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - |
Based on reports of an LD50 value for rabbits of > 2,000 mg/kg (EPA RED (2005), JMPR (1996)), this substance was classified as "Not classified." The category was revised based on the revision of the GHS Classification Guidance for the Japanese Government. Besides, for this substance, based on expert judgment, JMPR was preferentially adopted as the information source of LD50 values. |
| 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. Besides, LC50 value (4 hours) of >1.79 mg/L is reported in DFGOT Vol.11 (1998) for rats, but a category cannot be determined based on this value. The category was revised based on the revision of the GHS Classification Guidance for the Japanese Government. |
| 2 | Skin corrosion/irritation | Not classified |
- |
- | - | In primary dermal irritation tests using rabbits (4-hour application), no irritation was observed (JMPR (1996)), PATTY (6th, 2012)). Therefore, this substance was classified as "Not classified." The category was revised in accordance with the GHS Classification Guidance for the Japanese Government. |
| 3 | Serious eye damage/eye irritation | Category 2A |
Warning |
H319 |
P305+P351+P338
P337+P313 P264 P280 |
In primary eye irritation tests using rabbits based on the Draize method, severe irritation (corneal opacity, chemosis, redness of the conjunctivae, and ocular discharge) was observed (JMPR (1996)), EPA RED (2002), PATTY (6th, 2012)). Based on the above, this substance was classified in Category 2A. The category was revised in accordance with the GHS Classification Guidance for the Japanese Government. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 4 | Skin sensitization | Not classified |
- |
- | - | A dermal sensitization test by the Buehler method using guinea pigs was negative (EPA RED (2005), JMPR (1996)). Therefore, this substance was classified as "Not classified." |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | As it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese Government, this substance was classified as "Classification not possible." In in vivo tests, a mouse dominant lethal test was negative, a sister chromatid exchange test using mouse spermatogonia was positive, a micronucleus test using mouse bone marrow cells was negative, chromosome aberration tests using rat bone marrow cells were negative, chromosome aberration tests using mouse bone marrow cells were positive and negative, a sister chromatid exchange test using rat lymphocytes was negative, and a sister chromatid exchange test using mouse bone marrow cells was positive (JMPR (1996), DFGOT Vol.11 (1994), ACGIH (7th, 2001), ACGIH (7th, 2013), EHC 29 (1984), IARC 113 (in prep., Access on June 2016), PATTY (6th, 2012)). In in vitro tests, bacterial reverse mutation tests were negative; gene mutation tests in mammalian cell cultures had positive and negative findings; and chromosome aberration tests and sister chromatid exchange tests had negative or positive findings (JMPR (1996), DFGOT Vol.11 (1994), ACGIH (7th, 2013), PATTY (6th, 2012), EHC 29 (1984)). As described above, while a very small number of positive findings are found both in vivo and in vitro, most of the findings are negative. It was concluded in WHO (1996) and PATTY (6th, 2012) that this substance is not genotoxic. Therefore, this substance was judged not genotoxic in this classification as well. |
| 6 | Carcinogenicity | Category 2 |
 Warning |
H351 |
P308+P313
P201 P202 P280 P405 P501 |
IARC classified this substance in Group 2B, based on inadequate evidence in humans and limited evidence in experimental animals in its latest evaluation (IARC 113 (in prep., Access on June 2016), IARC Press Release No. 236 (Access on June 2016)). While there is no change in this evaluation from the previous classification (IARC Suppl. 7 (1987)), it is stated that there is strong evidence that this substance induces oxidative stress, a mechanism that can operate in humans, and moderate evidence that this substance causes immunosuppression (IARC Press Release No. 236 (Access on June 2016)). Therefore, this substance was classified in Category 2. Additionally, as for classifications by other organizations, since 2001 ACGIH has classified the substance in A4 (ACGIH (7th, 2013)), and in 1997 the EPA classified the substance in Group D (Chemicals Evaluated for Carcinogenic Potential (2015)); both of these classifications correspond to "Classification not possible." |
| 7 | Reproductive toxicity | Category 2 |
Warning |
H361 |
P308+P313
P201 P202 P280 P405 P501 |
In humans, there is a case report, involving one case only, that the child of a mother who was exposed to a product containing this substance during the 6 months before conception and about the first 5 weeks of pregnancy was born with severe mental retardation and multiple congenital anomalies which are not typical of genetic defects (DFGOT Vol. 11 (1998)). As for experimental animals, in a two-generation reproductive toxicity study using rats by the oral route (feeding), even at the doses (20?80 mg/kg/day) at which a focal increase in the nuclear density in renal tubules and decreased weight gain were seen in F0 and F1 parental animals, no effects were seen on fertility; however, in the F1 pups, lows in body weight, a decreased survival rate, and skeletal variations and anomalies (increases in curved ribs, rudimentary ribs, and sternebrae anomalies) were seen (Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006)). In developmental toxicity tests in which pregnant rats or rabbits were dosed by gavage during the organogenesis period (rats: gestation days 6 to 15; rabbits: gestation days 6 to 18), in the test using rabbits no abnormalities were observed in both the dams and the fetuses; however, with the rats, skeletal variations and anomalies (increased incidences of cervical and lumbar ribs and of sternebrae defects) were observed (Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006), ACGIH (7th, 2013)). From the above, in experimental animals, decreased survival rates and skeletal anomalies were seen among pups or fetuses at doses at which effects of toxicity were seen in parental animals. Therefore, this substance was classified in Category 2 for this hazard class. |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (nervous system), Category 3 (narcotic effects) |
Danger Warning |
H370
H336 |
P308+P311
P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312 |
In humans, there are reports of effects on the nervous system, such as coma, total loss of reflexes, loss of consciousness, and muscular hypotonia, due to oral ingestion of this substance mostly with the intention of committing suicide (ACGIH (7th, 2011, 2013), EHC 29 (1984), DFGOT Vol.4 (1992)). In addition, it has been reported that, in a study in which 11 field workers (female, 35-52 years of age) exposed to this substance were followed for two years, at the initial examination following exposure, cardiac pain, heart palpitations, dyspnea, periodic headache and vertigo, fatigue, and pain in the legs and arms were observed (ACGIH (7th, 2013), Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006)). Furthermore, in a single oral exposure study using rats, it has been reported that incoordination, slight to moderate gait changes, and other movement difficulties attributed to myotonia were seen at a dose within the range of the guidance values for Category 1 (ACGIH (7th, 2013)). From the above, this substance was classified in Category 1 (nervous system) and Category 3 (narcotic effects). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (nervous system, haemal system, liver, kidney) |
Danger |
H372 |
P260
P264 P270 P314 P501 |
As for humans, it has been documented that a person who orally ingested this substance for three weeks at 500 mg per day showed chronic poisoning and marked miosis (Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006)). As for experimental animals, in a 13-week repeated dose toxicity test using rats administered by feeding, effects on the haemal system (decreases in hemoglobin concentration, hematocrit value, counts of erythrocytes and reticulocytes) were seen at 5mg/kg/day, which is equivalent to Category 1 (Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006). In another 13-week repeated dose toxicity test using rats administered by feeding, effects on the liver (increases in liver weight and in AST, ALT, and centrilobular hepatocellular hypertrophy), effects on the adrenal glands (an increase in adrenal weight and hypertrophy of cells of the zona glomerulosa), and effects on the kidneys (brush border loss in proximal tubular cells) were seen at 100 mg/kg/day, which is equivalent to Category 2 (JMPR (1996)). In a 2-year repeated dose toxicity test using rats administered by feeding, effects on the kidneys (an increased frequency of a brown tubular epithelial-cell pigment, pelvic microcalculi, and transitional epithelial-cell hyperplasia) were seen at 5mg/kg/day, which is equivalent to Category 1 (Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006), JMPR (1996)); and in a separate 2-year repeated dose toxicity test using rats dosed by feeding, effects on the liver (increases in AST, ALT, alkaline phosphatase; hepatic lesions with altered tinctorial properties of hepatocytes within the hepatic nodules were observed, but not associated with hepatocellular degeneration or necrosis), effects on the thyroid (decreased thyroxine levels and increases in thyroid weights), and effects on the kidneys (degeneration of the descending portion of the proximal convoluted tubules) were seen at 75 mg/kg/day, which is equivalent to Category 2 (JMPR (1996)). In a 1-year repeated dose toxicity tests using dogs administered by feeding, effects on the kidneys (increased blood urea nitrogen and creatinine levels, and an increase in pigment in the tubular epithelium of the kidneys) and effects on the liver (increased ALT and inflammation of the liver) were seen at 5 mg/kg/day, which is equivalent to Category 1 (Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006), JMPR (1996)). Elsewhere, effects have been seen in the kidneys in 13-week repeated dose toxicity tests using mice and dogs dosed by feeding. Among these, findings in the thyroid and adrenal glands were considered to be adaptive responses, or secondary findings, etc., and were therefore not used as rationale for classification. Therefore, this substance was classified in Category 1 (nervous system, haemal system, liver, kidney). |
| 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 96-hour LC50 = 70.1 mg/L for fish (Morone saxatilis) (EHC 84, 1989), it was classified in Category 3. Besides, although it is reported that the ester form of 2,4-D is more toxic than the acid form, because the CAS number is for the acid form, the classification was conducted using the data on the acid form at the judgment of the expert. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 3 |
- |
H412 |
P273
P501 |
Reliable chronic toxicity data were not obtained. Due to being not rapidly degradable (a degradation rate by BOD: 0 % (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2002)), and acute toxicity Category 3, it was classified in Category 3. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
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* 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. |