GHS Classification Result

Chemical Name：4-Chloro-2-nitroaniline
CAS：89-63-4

Result：
ID: 22A4182
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2010
Reference Manual: GHS Classification Guidance by the Japanese Government （July, 2010）

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Classification not possible - - - - It contains chemical groups (N-O) associated with explosive properties present in the molecule, but classification is not possible due to lack of additional data. It needs expert judgement.
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 - - - - No data available.
8 Self-reactive substances and mixtures Classification not possible - - - - It contains chemical groups (N-O) associated with explosive properties present in the molecule. Since no test results are available, classification is not possible. It needs expert judgement.
9 Pyrophoric liquids Not applicable - - - - Solid (GHS definition)
10 Pyrophoric solids Not classified - - - - Since its autoignition temperature is 530 degC (Hommel (1996)), it is considered that the substance does not ignite at room temperature.
11 Self-heating substances and mixtures Classification not possible - - - - Test methods applicable to solid (melting point <= 140 degC) 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 Classification not possible - - - - Although the substance is an organic compound containing oxygen which is chemically bonded to the elements other than carbon or hydrogen, classification is not possible due to lack of additional data.
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure.
16 Corrosive to metals Classification not possible - - - - Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity （Oral） Not classified - - - - Based on the rat LD50 value of > 5000 mg/kg bw (BUA No. 235 (2002)), the substance was classified as "Not classified".
1 Acute toxicity （Dermal） Classification not possible - - - - No data available.
1 Acute toxicity （Inhalation: Gases） Not applicable - - - - Solid (GHS definition)
1 Acute toxicity （Inhalation: Vapours） Classification not possible - - - - No data available.
1 Acute toxicity （Inhalation: Dusts and mists） Classification not possible - - - - No data available.
2 Skin corrosion/irritation Not classified - - - - The substance was classified as "Not classified" based on the document that the occlusive application of 500 mg of test substance for 4 hours caused no skin irritation in rabbit test (BUA 235 (2002)).
3 Serious eye damage/eye irritation Not classified - - - - The substance was classified as "Not classified" based on the rabbit test (FDA guideline) that 24-hour application of test substance caused no irritation in rabbit eye (BUA 235 (2002)).
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - Insufficient data were available. It was reported that 4 out of 4 animals revealed positive reactions in the guinea pig test (BUA 235 (2002)). But details on methods and results were unknown.
5 Germ cell mutagenicity Not classified - - - - The classification was concluded as "Not classified" based on the negative results in the micronucleus test using bone marrow obtained from mice orally administered (in vivo mutagenicity test in somatic cells) (OECD TG 474, GLP-compliant) (BUA No. 235 (2002)). As relevant information, as for in vitro studies, positive results were reported in the Ames test, the chromosome aberration test using CHO cells and the gene mutation test using mouse lymphoma cells (NTP DB (Access on Oct. 2010)).
6 Carcinogenicity Classification not possible - - - - No data available.
7 Reproductive toxicity Classification not possible - - - - In the combined repeated dose toxicity study with the reproduction/developmental toxicity screening test in rats (OECD TG 422, GLP-compliant), no effects on reproductive parameters such as the mating index, fertility index, parturition index, gestational period, number of corpora lutea or number of implantations, delivery index, indices of gestation or lactation behavior were observed on parental animals. And no significant differences in the number of offspring, live birth index, or viability index on day 4, external features, clinical signs were observed in the offspring (Safety Test Results (Ministry of Economy, Trade and Industry) (Access on Oct. 2010)). Therefore, no adverse effects were observed on the reproductive functions and fertility of parental animals. However, since the fetal inspection at the end stage of pregnancy period was not carried out, it is insufficient for evaluation of the developmental effects. Therefore, the substance was classified as "Classification not possible".
8 Specific target organ toxicity - Single exposure Classification not possible - - - - Insufficient data were available. As relevant information, transient prone position in rats as well as a decrease in spontaneous locomotor activity and unsteady gait in mice were observed as clinical signs after single oral administration, in addition to the report mentioning that deep narcosis lasted up to 24 hours after single oral administration of the substance to guinea pigs (BUA No. 235 (2002)). However, the dose levels which revealed these findings were the doses over the upper limit of the guidance values.
9 Specific target organ toxicity - Repeated exposure Category 2 (blood system) Warning H373: May cause damage to organs through prolonged or repeated exposure (blood system) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ... 		In the 13-week gavage study in rats, deposition of hemosiderin in the spleen was observed with dose dependency in males at 400 mg/kg/day or more and in females at 50 mg/kg/day or more, and decreases in erythrocyte count and hematocrit value was additionally revealed at 800 mg/kg/day (BUA 235 (2002)). Moreover, increased extramedullary hematopoiesis in the spleen and a decrease in hematocrit value were noted at doses of 60 mg/kg/day (converted dose level as that of 90-day study: 28 mg/kg/day) or more in the combined repeated dose toxicity study with the reproductive/developmental toxicity screening test in rats (Safety Test Results (Ministry of Economy, Trade and Industry) (Access on Oct. 2010)). In the 13-week repeated dose oral study in mice, deposition of hemosiderin in the spleen was also reported in females at 75 mg/kg/day (BUA 235 (2002)). Since the effects described above were observed in the doses equivalent to Category 2 of the guidance values, the substance was classified as Category 2 (blood system). In addition, it was reported that in the 13-week repeated dose study in rats described above, hyaline droplets and regeneration in the proximal tubules of the kidney, which was considered to be male rat specific, were noted at doses of 100 mg/kg/day or more (BUA 235 (2002)). Furthermore, there was the description stating that the substance might occur methemoglobinemia in humans (BUA 235 (2002)).
10 Aspiration hazard Classification not possible - - - - No data available.

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: Toxic to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ... 		Classified into Category 2 from its 48h-EC50 = 3.2 mg/L for crustacea (Daphnia magna) (AQUIRE, 2011; HSDB, 2008; BUA 235, 2002).
11 Hazardous to the aquatic environment （Long-term） Category 2 - H411: Toxic to aquatic life with long lasting effects P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ... 		Classified into Category 2 since its acute toxicity is Category 2 and it is not rapidly degradable (2w-BOD degradation rate tested by OECD TG301C = 0% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 1977)).
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTE:
* 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.

Reference：
Reference Manual
Definitions / Abbreviations
Model Label by MHLW

 MHLW Website （in Japanese Only）
Model SDS by MHLW

 MHLW Website （in Japanese Only）

To GHS Information