GHS Classification Result

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GENERAL INFORMATION

Item Information
CAS number 99-88-7
Chemical name 4-Isopropylaniline
Substance ID 23A5013
Fiscal year of classification conducted FY2011
Classifier(s) (Ministries) Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
New/Revised New
Download in Excel format Excel file

REFERENCE INFORMATION

Item Information
Guidance used for classification (External link) Physical Hazards & Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010)
Environmental Hazards: UN GHS Document (4th revised edition)
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

PHYSICAL HAZARDS

Hazard class Classification Symbol
Signal word
Hazard statement Precautionary statement 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 - - - "Liquids" according to GHS definition.
3 Aerosols Not applicable - - - Not an aerosol product.
4 Oxidizing gases Not applicable - - - "Liquids" according to GHS definition.
5 Gases under pressure Not applicable - - - "Liquids" according to GHS definition.
6 Flammable liquids Category 4
Warning
H227
P370+P378
P403+P235
P210
P280
P501
A flash point of 92 degrees C [closed-cup] (NITE Chemical Risk Information Platform (Access on Dec. 2010) (Acros reagent catalog)) is > 60 degrees C and <= 93 degrees C, therefore, it corresponds to Category 4.
7 Flammable solids Not applicable - - - "Liquids" according to GHS definition.
8 Self-reactive substances and mixtures Not applicable - - - Containing neither chemical groups related to explosibility nor those related to self-reactivity.
9 Pyrophoric liquids Not classified - - - It is conceivable that it does not ignite at normal temperatures from an ignition temperature of 540 degrees C (IUCLID (2000)).
10 Pyrophoric solids Not applicable - - - "Liquids" according to GHS definition.
11 Self-heating substances and mixtures Classification not possible - - - No established test method suitable for liquid substances.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable - - - Not containing metals or semimetals (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13 Oxidizing liquids Not applicable - - - An organic compound that does not contain oxygen, fluorine, or chlorine.
14 Oxidizing solids Not applicable - - - "Liquids" according to GHS definition.
15 Organic peroxides Not applicable - - - An organic compound that does not contain -O-O- structure.
16 Corrosive to metals Classification not possible - - - No data.

HEALTH HAZARDS

Hazard class Classification Symbol
Signal word
Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Category 4

Warning
H302
P301+P312
P264
P270
P330
P501
On the basis of an LD50 value of 985 mg/kg for rats (OECD TG401, GLP) (Report on Toxicity Tests of Chemical Substances, MHLW (Access on Dec. 2010)), it was classified in Category 4.
1 Acute toxicity (Dermal) Category 4

Warning
H312
P302+P352
P280
P312
P322
P363
P501
Both LD50 values for rats, 1000-1250 mg/kg in males and 1030 mg/kg in females (OECD TG402, GLP) (IUCLID (2000)), correspond to Category 4.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - "Liquids" according to GHS definition.
1 Acute toxicity (Inhalation: Vapours) Classification not possible - - - No data.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - No data.
2 Skin corrosion/irritation Category 1

Danger
H314
P301+P330+P331
P303+P361+P353
P305+P351+P338
P304+P340
P260
P264
P280
P310
P321
P363
P405
P501
On the basis of a result as "corrosive" in a test using rabbits (OECD TG 404: GLP) (IUCLID (2000), it was classified in Category 1.
3 Serious eye damage/eye irritation Category 2

Warning
H319
P305+P351+P338
P337+P313
P264
P280
From a result as "moderately irritating" in a test using rabbits (IUCLID (2000), it was classified in Category 2.
4 Respiratory sensitization Classification not possible - - - No data.
4 Skin sensitization Classification not possible - - - No data.
5 Germ cell mutagenicity Classification not possible - - - The classification is not possible due to no in vivo test data.
Besides, as in vitro tests, a positive in a Ames test (OECD TG471; GLP) (with the addition of S9mix), a negative in a chromosomal aberration test using Chinese hamster lung cells (OECD TG 473; GLP) (Report on Toxicity Tests of Chemical Substances, MHLW (Access on Dec. 2010)), and a negative in an HGPRT test using V79 cells (OECD TG 476; GLP) (IUCLID (2000)) are reported respectively.
6 Carcinogenicity Classification not possible - - - No data.
7 Reproductive toxicity Category 2

Warning
H361
P308+P313
P201
P202
P281
P405
P501
In a combined repeated dose toxicity study with reproduction/development toxicity screening test (OECD TG 422; GLP) in which rats were orally administrated from 14 days before mating, methemoglobinemia and anemia as general toxicities were initiated at doses of 20 mg/kg/day or higher in parent animals, but no adverse effects on sex cycle, copulation ability, and fertility, and no adverse effects during deliveries and pregnancy period were observed (Report on Toxicity Tests of Chemical Substances, MHLW (Access on Dec. 2010)).
But in a high dose group (60 mg/kg), body weight on day 0 showed a low value in both sexes of newborns, and Viability Index on Day 4 after birth showed a statistically significant low value in newborn males and showed a low-value tendency in newborn females (Report on Toxicity Tests of Chemical Substances, MHLW (Access on Dec. 2010)), therefore it was classified in Category 2.
8 Specific target organ toxicity - Single exposure Category 1 (blood)

Danger
H370
P307+P311
P260
P264
P270
P321
P405
P501
On the basis of a report in which single-dose oral administration of 25 mg/kg, which corresponds to Category 1 in guidance values, to cats caused increased methemoglobin concentration and increased Heinz body (SIDS (2005)), it was classified in Category 1 (blood).
9 Specific target organ toxicity - Repeated exposure Category 1 (blood system)

Danger
H372
P260
P264
P270
P314
P501
On the basis of a report in which methemoglobinemia and anemia were initiated and changes, which were considered to be caused by those, such as general toxicities, hematological test results, excessive hematopoiesis in bone marrow, extramedullary hematopoiesis in liver and spleen were observed at doses of not less than 20 mg/kg (converted to a 90-day equivalent value: ca. 10 mg/kg/day), which corresponds to an upper limit of Category 1, in a combined repeated dose toxicity study with reproduction/development toxicity screening test (OECD TG 422; GLP) in which rats were orally administrated 6, 20, and 60 mg/kg/day (Report on Toxicity Tests of Chemical Substances, MHLW (Access on Dec. 2010)), it was classified in Category 1 (blood system).
10 Aspiration hazard Classification not possible - - - No data.

ENVIRONMENTAL HAZARDS

Hazard class Classification Symbol
Signal word
Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Category 2 - H401
P273
P501
It was classified in Category 2 from 48-hour EC50 = 1.5 mg/L for crustacea (Daphnia magna) (Ecotoxicity tests by Environment agency, 1998).
11 Hazardous to the aquatic environment (Long-term) Category 1

Warning
H410
P273
P391
P501
If chronic toxicity data are used, then it is classified in Category 1 because it is non-rapidly degradable (a degradation rate by BOD: 1 % (the existing chemicals survey program, 2002)) and 21-day NOEC = 0.0051 mg/L for crustacea (Daphnia magna) (Ecotoxicity tests by Environment agency, 1998).
If acute toxicity data are used for trophic levels for which chronic toxicity data are lacking, then it is classified in Category 3 because it is non-rapidly degradable (a degradation rate by BOD: 1 % (the existing chemicals survey program, 2002)) and 96-hour LC50 = 46 mg/L for fish (Oryzias latipes) (Ecotoxicity tests by Environment agency, 1998).
It was classified in Category 1 by a comparison between the above results.
12 Hazardous to the ozone layer Classification not possible - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTES:
* 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.



Updated date:
2016/6/29 Addition of Rationale for the classification

List of GHS Classification Results