GHS Classification Result

Chemical Name：2,4-Diaminophenol dihydrochloride; Amidol
CAS：137-09-7

Result：
ID: 22A4089
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 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 - - - - No data available.
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 Classification not possible - - - - No data available.
11 Self-heating substances and mixtures Classification not possible - - - - No data 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 chlorine and oxygen which are chemically bonded only to carbon or hydrogen.
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） Category 3 Danger H301: Toxic if swallowed P301+P310: IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P321: Specific treatment （see ... on this label）.
P330: Rinse mouth.
P405: Store locked up.
P501: Dispose of contents/container to ... 		Based on the rat LD50 value of 240 mg/kg (RTECS (2003), original literature: Journal of the American College of Toxicology. Volume 13, (1994)), the substance was classified into Category 3.
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 Classification not possible - - - - No data available.
3 Serious eye damage/eye irritation Classification not possible - - - - No data available.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - No data available.
5 Germ cell mutagenicity Classification not possible - - - - The classification was not possible due to lack of in vivo test data. As relevant information, as for in vitro studies, positive results in the Ames test and mouse lymphoma assay (NTP DB (Access on August 2010)) and negative results in the chromosome aberration test using CHO cells (NTP DB (Access on August 2010)) were reported.
6 Carcinogenicity Classification not possible - - - - There are 2-year oral studies in rats and mice. In these studies, no evidence of carcinogenicity in both sexes of rats and female mice. However, renal tubular adenomas, rare tumor, were observed in the high dose group in male mice, concluding a certain evidence of carcinogenicity (NTP TR 401 (1992)). As relevant information, an increase or increasing tendency in the incidence of renal tubular epithelial hyperplasia in both sexes in mice, and an increase in proliferative changes in the tubules also observed in rats, suggesting a carcinogenicity in the kidney. However, these data are still insufficient as an evidence of carcinogenicity of this substance. Therefore, it was concluded as "Classification not possible".
7 Reproductive toxicity Classification not possible - - - - No data available.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - No data available.
9 Specific target organ toxicity - Repeated exposure Category 2 (kidney, hematopoietic system) Warning H373: May cause damage to organs through prolonged or repeated exposure (kidney, hematopoietic 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 oral dose studies in rats and mice, renal tubule necrosis occurred in rats that received at the dose levels of 25 mg/kg/day or higher in males and 100 mg/kg/day or higher in females, while the incidence of renal tubule regeneration was increased in mice that received at 75 mg/kg/day or higher (NTP TR 401 (1992)). Additionally, in the 2-year oral dose studies in rats and mice, renal tubular changes containing hyperplasia, regeneration or necrosis were also reported (NTP TR 401 (1992)). Based on the documents, all the doses affected corresponded to Category 2 within the guidance values, thus, the substance was classified as Category 2 (kidney). Furthermore, a decrease of lymphocytes in the spleen, hyperplasia of bone marrow, hemosiderin deposition in Kupffer cells, and dose-dependent enhancement of extramedullary hematopoiesis in the spleen were found at doses of 100 mg/kg/day or higher in the 13-week study in rats (NTP TR 401 (1992)). From the information, Category 2 (hematopoietic system) was added. In addition, acanthosis and hyperkeratosis of the forestomach, or ulcers associated with them were observed in both studies of rats and mice (NTP TR 401 (1992)). However, since the studies were the gavage ones which could not deny the potential physical effect by insertion of the gastric tube, the findings of the forestomach were not adopted for the classification.
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） Classification not possible - - - - No data available.
11 Hazardous to the aquatic environment （Long-term） Classification not possible - - - - No data available.
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）

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