GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 75-31-0 |
| Chemical Name | Isopropylamine |
| Substance ID | H29-B-120 |
| 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) | |
| 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 |
- |
- | - | Liquid (GHS definition) |
| 3 | Aerosols | Not applicable |
- |
- | - | Not aerosol products. |
| 4 | Oxidizing gases | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 5 | Gases under pressure | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 6 | Flammable liquids | Category 1 |
 Danger |
H224 |
P303+P361+P353
P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501 |
Based on a flash point of -37 deg C (closed cup), and a boiling point of 31.7 deg C (ICSC (J) (2015)), it was classified in Category 1. Besides, it is classified in Class 3, Subsidiary risk 8, PGI in UNRTDG (UN 1221). |
| 7 | Flammable solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 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 classified |
- |
- | - |
It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 400 deg C (GESTIS (Access on September 2017)). |
| 10 | Pyrophoric solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | Test methods applicable to liquid 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 |
- |
- | - | Organic compounds containing no oxygen, fluorine or chlorine |
| 14 | Oxidizing solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 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 low-temperature-boiling liquids are not available. |
| 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 |
There are three reports of the LD50 values of 122 mg/kg, 552mg/kg (SIDS (2016)) and 820 mg/kg (PATTY (6th, 2012)) for rats, and one of the data corresponds to Category 3, two data correspond to Category 4. It was classified in Category 4 to which the largest number of data corresponds. The category was revised from the previous classification by use of a new information source. |
| 1 | Acute toxicity (Dermal) | Category 3 |
 Danger |
H311 |
P302+P352
P361+P364 P280 P312 P321 P405 P501 |
There are two reports of the LD50 values of 0.55 mL/kg (385 mg/kg) (PATTY (6th, 2012)), > 400 mg/kg (according to OECD TG 402) (SIDS (2016)) for rabbits. One corresponds to Category 3. Another corresponds to Category 4 or "Not classified," however, the classification could not be determined. The category with higher hazard was adopted, and it was classified in Category 3. Besides, when the assessment reports were confirmed, the LD50 value for rats described in PATTY (5th, 2001) which was adopted as the evidence of classification in the previous classification was the same rabbit data as in PATTY (6th, 2012). |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Category 4 |
Warning |
H332 |
P304+P340
P261 P271 P312 |
The LC50 value of 11.5 mg/L (4,761 ppm) (converted 4-hour equivalent value: 5.75 mg/L (2,381 ppm)) for rats in a 1-hour inhalation exposure test and the LC50 value of 8.7 mg/L (3,602 ppm) for rats in a 4-hour inhalation exposure test were reported (both from SIDS (2016)), one data corresponds to Category 3, and another corresponds to Category 4. According to the GHS classification guidance for the Japanese Government, the data of 4-hour inhalation exposure test was adopted, and this substance was classified in Category 4. Besides, since the exposure concentrations are lower than 90% of the saturated vapor pressure concentration (764,957 ppm), the reference values in the unit of ppm was applied as vapour with little mist. |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 2 | Skin corrosion/irritation | Category 1A |
 Danger |
H314 |
P301+P330+P331
P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501 |
Based on the description that in a skin irritation test with rabbits (equivalent to OECD TG 404), necrosis, followed by eschar, occurred within 24 hours after 3-minute application of this substance, and a description that corrosion was seen in both of other two tests with rabbits (application time: 1, 5, 15 minutes or 24 hours) (both from SIDS (2016)), this substance was classified in Category 1A. Besides, this substance is classified as "Skin Irrit. 2, H315" in EU CLP classification (ECHA CL Inventory (Access on August 2017)). Based on the information obtained in this investigation, the category was changed. |
| 3 | Serious eye damage/eye irritation | Category 1 |
Danger |
H318 |
P305+P351+P338
P280 P310 |
This substance is classified Category 1A for skin corrosion/irritation. There is a description that in an eye irritation test with rabbits (equivalent to OECD TG 405), it showed corrosivity, by causing severe conjunctival irritation (erythema, chemosis, discharge, and necrosis), corneal opacity, and ulceration 24 hours after the application of this substance, and a description that in other two tests with rabbits, it showed corrosivity in both cases (SIDS (2016)). Therefore, this substance was classified in Category 1. Besides, this substance is classified as "Eye Irrit. 2, H319" in EU CLP classification (ECHA CL Inventory (Access on August 2017)). |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 4 | Skin sensitization | Classification not possible |
- |
- | - | There are descriptions that no skin sensitization was found in a maximization test with guinea pigs (according to OECD TG 406) and that there was no skin sensitization in a LLNA test with mice (both by SIDS (2016)). This substance was classified as "Classification not possible" because no humans data was available. |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. No in vivo data was available, and as for in vitro, bacterial reverse mutation tests, in vitro mammalian cell mouse lymphoma tests and chromosome aberration tests were negative (SIDS (2016), HSDB (Access on August 2017), NTP DB (Access on September 2017)). |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - |
In a one-generation reproduction toxicity study with rats exposed by inhalation, reproductive and developmental effects were not observed in the parental animals of males and females at up to the highest dose (499 mg/m3) at which 2/20 death cases were observed in paternal animals (SIDS (2016)). In addition, in a developmental toxicity study with pregnant rats exposed by inhalation during the period of organogenesis (gestation day 6-15), skeletal abnormalities (reduced ossification of the 13th rib, curved ribs) were observed in pups at the highest dose (1,000 mg/m3) where maternal toxicity (symptoms such as decreased weight gain, nasal discharge, rales, and labored breathing) was observed, but they were not statistically significant changes (SIDS (2016)). From the above, no findings which suggested reproductive and developmental effects were observed by inhalation route, however, no toxicity information by oral route was available. Therefore, this substance was classified as "Classification not possible" due to lack of data. |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (central nervous system, respiratory organs), Category 3 (narcotic effects) |
 Danger Warning |
H370
H336 |
P308+P311
P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312 |
As for humans, in a test with volunteers, complaints of irritation of the nose and throat by the subjects were reported after brief inhalation exposures at 10-20 ppm (ACGIH (7th, 2001), PATTY (6th, 2012)). As for experimental animals, it is reported that in 3 single dose oral administration studies with rats, decreased activity, staining around the nose and mouth, and labored breathing were observed at 118 mg/kg corresponding to Category 1; lethargy, labored breathing, piloerection and prostration were observed at about 173 mg/kg corresponding to Category 1; and intermittent respiration, blood crusts around the nose and ruffled fur were observed at 346 mg/kg corresponding to Category 2 (all reports from SIDS (2016)). As for dermal route, there is a report that in a single dermal exposure test with rats, dyspnea, apathy, staggering, spastic gait, tremor, piloerection, exophthalmos and poor general state were observed at 400 mg/kg corresponding to Category 1, but there were no mortalities (SIDS (2016)). As for inhalation route, there is a report that in a 4-hour single inhalation exposure test with rats, labored breathing, lacrimation, nasal discharge, reduced activity, closed eyes and moist and dry rales were observed at 2.8-6.5 mg/L corresponding to Category 1, and there was no description on cases of survival or death in gross findings at necropsy, however, a few cases of lung emphysema as well as reddening and swelling of the lungs were observed (SIDS (2016)). In addition, there is a report that in a 1-hour inhalation exposure study with rats, gasping, labored breath and rales were observed at or above 6.6 mg/L, a converted 4-hour equivalent value of which is 3.3 mg/L and corresponding to Category 1. By combining the above information in humans and experimental animals, this substance was classified in Category 1 (central nervous system, respiratory organs), Category 3 (narcotic effects). The classification result was changed from the previous classification due to the use of a new information source. |
| 9 | Specific target organ toxicity - Repeated exposure | Category 2 (respiratory organs) |
Warning |
H373 |
P260
P314 P501 |
As for humans, there are reports on acute eye and respiratory effects, but no information is available for chronic effects (ACGIH (7th, 2001), PATTY (6th, 2012)). As for experimental animals, there is a report that in a 1-month inhalation toxicity test (6 hours/day, 5 days/week, 20 applications) with rats, decreased body weight, inflammatory changes and degeneration of the eyes and nose at or above 0.5 mg/L (converted guidance value: 0.1 mg/L), which is within a guidance value range (vapor) for Category 1, and at 1.35 mg/L (converted guidance value: 0.3 mg/L), which is within a guidance value range (vapor) for Category 2, general conditions (ocular opacity, nasal crust etc.) which indicated eye and nose irritation were observed (HSDB (Access on August 2017)). In addition, in a 13-week inhalation toxicity test (6 hours/day, 5 days/week) with rats, at 499 mg/m3 (converted guidance value: 0.36 mg/L), which is within a guidance value range (vapor) for Category 2, nasal inflammation in females was reported (SIDS (2016)). From the above, although there are reports of the effects of irritation on the eyes and nose, the effects on the eyes were considered to be the result of eye irritation, thus, they were not adopted as target organ for this hazard class. Furthermore, the information source of the test in which the effects were seen within a guidance value range for Category 1 is listed in List 2. Therefore, this substance was classified in Category 2 (respiratory organs). Besides, SITTIG (47th, 2002) which was used for the previous classification was not adopted because this information source is currently listed in List 3, and the effects on the eyes which were considered to be due to the eye irritation were not adopted as the evidence of the classification, thus, the classification result was different from the previous one. |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Besides, in the previous classification, this substance was classified in Category 2 by using the information source listed in List 3, however, the evidence was not from a report based on humans cases etc., but from a general attention remark. Additionally, according to the Japan Industrial Standard (JIS) on the GHS classification (JIS Z 7252:2014) published after the previous classification, a substance can be allocated only to Category 1, not to Category 2, for this hazard class. |
| 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 48-hour EC50 (immobile) = 91.6 mg/L for crustacea (Daphnia magna) (EPA AQUIRE: 2017, Chester, N. A. et al. (1992)), it was classified in Category 3. |
| 11 | Hazardous to the aquatic environment (Long-term) | Not classified |
- |
- | - | Chronic toxicity data were not obtained. Due to being rapidly degradable (BioWin), and no bioaccumulation (LogPow: 0.26 (SRC PhysProp Database: 2017)), it was classified as "Not classified." |
| 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. |