GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 101-14-4
Chemical Name 3,3'-Dichloro-4,4'-diaminodiphenylmethane
Substance ID 23B5508
Classification year (FY) FY2011
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) Physical Hazards & Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th revised edition)
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

PHYSICAL HAZARDS
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 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
-
-
- - Test methods applicable to solid (melting point <= 140 deg C) 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 Not applicable
-
-
- - The substance is an organic compound containing chlorine (but not fluorine or oxygen) which is chemically bonded only to carbon.
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 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
Among four LD50 values for rats (> 2,000 mg/kg (OECD TG 423, GLP) (Toxicity Testing Reports of Environmental Chemicals (Chemicals Investigation Promoting Committee) (2004)), 1,140 mg/kg (Environmental Risk Assessment for Chemical Substances vol. 7 (Ministry of the Environment, 2009)), 2,100 mg/kg, and 750 mg/kg (ACGIH (2001))), two correspond to "Not classified" in the Classification JIS, and two correspond to Category 4. It was classified in Category 4 by adopting the category with higher hazard.
1 Acute toxicity (Dermal) Not classified
-
-
- - It was classified as "Not classified" based on an LD50 value of > 5,000 mg/kg for rabbits (Environmental Risk Assessment for Chemical Substances vol. 7 (Ministry of the Environment, 2009)).
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
-
-
- - It was classified as "Not classified" in the Classification JIS (Category 3 in UN GHS classification) because it is reported that a skin irritation test with guinea pigs resulted in very slight irritation (Initial Risk Assessment Report 33 (NITE, CERI, NEDO, 2005)).
3 Serious eye damage/eye irritation Category 2B
-
Warning
H320 P305+P351+P338
P337+P313
P264
It was classified in Category 2B because it is reported that an eye irritation test with rabbits resulted in mild conjunctival irritation with no corneal or iritic effect (ACGIH (2001)).
4 Respiratory sensitization Classification not possible
-
-
- - No data available.
4 Skin sensitization Classification not possible
-
-
- - It is described that no skin sensitization was shown in a test with guinea pigs (Initial Risk Assessment Report 33 (NITE, CERI, NEDO, 2005)). However, because the details of test methods, positive rate, etc. are unknown, it was classified as "Classification not possible."
5 Germ cell mutagenicity Category 2


Warning
H341 P308+P313
P201
P202
P280
P405
P501
It was classified in Category 2 based on a positive result in a micronucleus test with bone marrow cells after intraperitoneal administration to mice (in vivo somatic cell mutagenicity test) (Initial Risk Assessment Report 33 (NITE, CERI, NEDO, 2005), ASTDR (1994)). Besides, it was reported to be positive in all of a sister chromatid exchange test with lymphocytes after intraperitoneal administration to rats and DNA adduct formation tests with the liver, kidney, and lung after oral administration to rats (in vivo somatic cell genotoxicity tests) (Initial Risk Assessment Report 33 (NITE, CERI, NEDO, 2005)). Furthermore, as for in vitro tests, it is reported that it was positive in an Ames test (NTP DB (Access on Dec. 2005)), a gene mutation test with mouse lymphoma cells (NTP DB (Access on Aug. 2011)), and a chromosomal aberration test with CHL cells (OECD TG 473, GLP) (Toxicity Testing Reports of Environmental Chemicals (Chemicals Investigation Promoting Committee) (2004)), and a chromosomal aberration test with cultured human leukocytes and a chromosomal aberration test with CHO cells gave negative results (Initial Risk Assessment Report 33 (NITE, CERI, NEDO, 2005)).
6 Carcinogenicity Category 1A


Danger
H350 P308+P313
P201
P202
P280
P405
P501
It was classified in Category 1A because IARC classified it in Group 1 for carcinogenicity (IARC 99 (2010)). Besides, in a 2-year diet administration test with rats, in addition to significant increases in incidences of lung adenomatosis and adenocarcinoma, occurrences of pleural mesothelioma, and hepatocellular adenoma and adenocarcinoma were observed. In a test with rats (male) given a standard diet containing protein for 18 months, significant increases in incidences of lung tumors, mammary adenocarcinoma, Zymbal's gland carcinoma, and hepatocellular carcinoma were found (IARC 99 (2010)). Furthermore, in a test by 9-year oral administration (capsules) to dogs (female), transitional cell carcinoma in the urinary bladder occurred (Initial Risk Assessment Report 33 (NITE, CERI, NEDO, 2005)), and in a test by 18-month diet administration of the hydrochloride of this substance to mice, a significant increase in an incidence of hepatoma was seen (IARC 99 (2010)). On the other hand, although little information was obtained in humans, there are reports on occurrences of urinary bladder cancer, which were considered to be due to occupational exposure to this substance (Environmental Risk Assessment for Chemical Substances vol. 7 (Ministry of the Environment, 2009)).
7 Reproductive toxicity Classification not possible
-
-
- - In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422, GLP) by oral administration to rats, salivation in males and females and lower body weight in females during late gestation were observed in the high dose group (50 mg/kg), but parent animals showed no changes in estrous cycle, pairing days until copulation, copulation index, fertility index, gestation length, the number of corpus lutea, implantation index, gestation index, parturition index, and parturition and lactation status. Also, in offspring, no treatment-related changes were found in the number of pups born, the number of pups alive, sex ratio, live birth index, body weight, morphology, and viability index on day 4 (JECDB (Access on Aug. 2011)). Therefore, no adverse effects on sexual function and fertility were seen at the dose where general toxicity occurred, but because data are lacking for effects on the development of offspring, including teratogenicity, it was classified as "Classification not possible."
8 Specific target organ toxicity - Single exposure Category 1 (blood)


Danger
H370 P308+P311
P260
P264
P270
P321
P405
P501
It is described that this substance affects the blood and may cause methemoglobin formation, inhalation causes cyanosis in the lip, nail, and skin, confusion, convulsion, dizziness, headache, nausea, and loss of consciousness, and ingestion additionally causes abdominal pain. It generates a burning sensation on contact with the skin, and the above effects may occur after absorption from the skin (Environmental Risk Assessment for Chemical Substances vol. 7 (Ministry of the Environment, 2009)). Furthermore, it is described that in a repeated oral administration test with dogs, a methemoglobin concentration of the blood was elevated in groups at or above 10 mg/kg/day on the first test day, and weakness, vomiting, pallor, and cyanosis occurred in groups at 40 and 80 mg/kg/day, and repeated administration of lower doses caused methemoglobinemia and macrocytic anemia (ACGIH (2001)), suggesting effects on blood system within the guidance values range for Category 1. Based on the above knowledge, it was classified in Category 1 (blood).
9 Specific target organ toxicity - Repeated exposure Category 2 (blood, liver)


Warning
H373 P260
P314
P501
In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats (OECD TG 422, GLP), in the 50 mg/kg group (converted guidance value: 23.3 mg/kg/day), increased methemoglobin level, decreases in erythrocyte counts, hemoglobin level, and hematocrit value, and increases in reticulocyte and platelet counts were seen in hematological tests, and blood biochemistry examination showed increases in total cholesterol and triglyceride, increases in LDH and gamma-GTP, and decreased A/G ratio. Histopathological examination revealed swelling, fatty degeneration, and single-cell necrosis of hepatocytes and a trend toward increases in hemosiderin deposit and extramedullary hematopoiesis in the spleen. In the 10 mg/kg group, a trend toward an increase in hemosiderin deposit in the spleen was observed in males (JECDB (Access on Aug. 2011)). From the above results, because apparent toxicity effects on the blood and liver were observed at doses corresponding to the guidance values for Category 2, it was classified in Category 2 (blood, liver). Besides, findings in the kidney were not adopted for classification because there were slight and may be nephropathy specific to male rats. Besides, slight methemoglobinemia and macrocytic anemia were reported in a 67-day oral administration test with dogs (doses not specified) (ACGIH (2001)).
10 Aspiration hazard Classification not possible
-
-
- - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Category 1


Warning
H400 P273
P391
P501
It was classified in Category 1 from 48-hour EC50 = 0.250 mg/L for crustacea (Daphnia magna) (Initial Risk Assessment (NITE, CERI, NEDO, 2005)).
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 due to being not rapidly degradable (a 4-week degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1978)), and 21-day NOEC = 0.0095 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2001), etc.).
If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 1 due to being not rapidly degradable (a 4-week degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1978)), and 96-hour LC50 = 0.606 mg/L for fish (Oryzias latipes) (Environmental Risk Assessment for Chemical Substances Vol. 7 (Ministry of the Environment, 2009)).
From the above results, it was classified in Category 1.
12 Hazardous to the ozone layer Classification not possible
-
-
- - This substance is not listed in the Annexes to the Montreal Protocol.


NOTE:
  • GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
  • Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
  • This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
  • Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
  • A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.

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