GHS Classification Result (Revision of the past classification result)

Chemical Name:p-Dichlorobenzene
CAS:106-46-7

Result:
ID: 21B3160
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2009
Reference Manual: GHS Classification Guidance by the Japanese Government (March, 2009)

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 molecules.
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 - - - - Classification is not possible since no data are available though the substance is combustible (ICSC (2003)).
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 Not classified - - - - Auto-ignition point is >500 degC (Ullmanns (E) (6th, 2003)) exceeding 70 degC.
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 Not applicable - - - - The substance is an organic compound containing chlorine 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 - - - - No data available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Not classified - - - - LD50 values are 500, 1000, 2515, >2000 mg/kg (DFGOT vol. 4 (1992)), 1625 mg/kg (ACGIH (2001)), 2515, 3790 and 3863 mg/kg (NICNAS (2000)) for rats, and three values correspond to Category 4, four values correspond to "Not classified" in JIS Classification (correspond to Category 5 in GHS classification) and one value corresponds to "Not classified" in JIS Classification (correspond to Category 5 or "Not classified" in GHS classification). The substance was classified as "Not classified" in JIS Classification (correspond to Category 5 in GHS classification) since 4 of 8 LD50 values are in this category.
1 Acute toxicity (Dermal) Not classified - - - - Based on LD50 values of >2000 mg/kg (EU-RAR No. 48 (2004)) and >6000 mg/kg (NICNAS (2000)) for rats, the substance was classified as "Not classified".
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) Not classified - - - - Based on LC50 (4h) values of 5.70 mg/L (Hazard Assessment Report (CERI, NITE) (2006)) and >=6.00 mg/L (EPA Guideline 870.1300, EPA RED case No.3058 (access on Jul. 2009)) for rats, the substance was classified as "Not classified". Since the LC50 values were higher than saturated vapour pressure concentration (3.17 mg/L), the classification criteria for dust were adopted.
2 Skin corrosion/irritation Not classified - - - - In humans, skin contact with the solid form of the substance causes negligible irritating effects (NICNAS (2000)). Prolonged and/or repeated cutaneous contact with the substance (liquid or vapour) causes slight irritation with burning sensation (EU-RAR No. 48 (2004)). A test with rabbits (application for 4-hour) revealed that the substance was slightly irritating for the skin (OECD TG404, Hazard Assessment Report (CERI, NITE) (2006)). Based on the reports, the substance was classified as "Not classified" in JIS Classification (correspond to Category 3 in GHS classification).
3 Serious eye damage/eye irritation Category 2 Warning H319: Causes serious eye irritation P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
In a case report of occupational exposure to the vapour of the substance, severe irritation is reported (NICNAS (2002), ACGIH (7th, 2001)). In a rabbit eye irritation test, observed conjunctival erythema and edema disappeared within 72-hour. There was no effect on iris or cornea. Mild eye irritation was noted (OECD TG405, Hazard Assessment Report (CERI, NITE) (2006)). Based on these data, the substance was considered to be severely irritating to the eyes and therefore was classified into Category 2.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Category 1 Warning H317: May cause an allergic skin reaction P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P333+P313: If skin irritation or rash occurs: Get medical advice/attention.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P272: Contaminated work clothing should not be allowed out of the workplace.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment (see ... on this label).
P363: Wash contaminated clothing before reuse.
P501: Dispose of contents/container to ...
There is a case report of allergic purpura in a 69-year man following skin contact to an armchair treated by this substance (NICNAS (2000)). In a guinea pig maximization test, the following results were obtained: score 1, 9/24 animals, score 2, 4/24 animals and score 3, 1/24 animals. Based on these results, the substance was determined to possess sensitizing property (Hazard Assessment Report (CERI, NITE) (2006)) and the substance was classified into Category 1.
5 Germ cell mutagenicity Not classified - - - - From in vivo tests, there are reports of a negative result in a dominant lethal test and 2 positive results in 6 micronucleus tests (EU-RAR No. 48 (2004)). However, there is a report of irreproducible for one of 2 the positive micronucleus tests (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 76 (2005)). All in vivo chromosomal aberration tests resulted in negative results (EU-RAR No. 48 (2004), NTP DB (access on July 2009). There is a report that the substance has a low potential for genotoxicity (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 76 (2005)). Based on the data, the substance was classified as "Not classified". As relevant information, in replication DNA synthesis tests, positive results were obtained (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 76 (2005), ATSDR (2006)) and it is reported that the result suggested the potential of tumor promoter activity (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 76 (2005)). From in vitro mutagenicity tests, there are reports of positive micronucleus tests (2 of 3 tests) and negative chromosomal aberration tests, gene mutation tests, and bacteria reverse mutation tests (EU-RAR No. 48 (2004)).
6 Carcinogenicity Category 2 Warning H351: Suspected of causing cancer P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
Based on the classifications of "2B" in IARC (IARC (1999)), "3" in EU classification (EU (2004)), "A3" in ACGIH (1990) (ACGIH-TLV (2009)), "R" in NTP (NTP (2000)) and "2B" in Japan Society For Occupational Health (JSOH) (2008), the substance was classified into Category 2. In 104-week inhalation tests in rats and mice (Results from Carcinogenicity tests (Ministry of Health, Labour and Welfare) (1995)), increased incidences of tumors were not observed in rats of either sex, and there were no evidences of carcinogenicity of p-dichlorobenzene in male or female F344/DuCrj (Fischer) rats. In mice, increased incidences of hepatocellular carcinoma and histiocytic sarcoma in the liver were observed in the males, and increased incidences of hepatocellular carcinoma, hepatocellular adenoma and bronchiolo-alveolar carcinoma in the lung were observed in the females. The results indicated the carcinogenicity of p-dichlorobenzene in male and female Crj:BDF1 mice. The Ministry of Health, Labour and Welfare has made a public announcement on guidelines in order to prevent the impairment of worker's health based on Industrial Safety and Health Act Article 28-3 (2005).
7 Reproductive toxicity Category 1B Danger H360: May damage fertility or the unborn child P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
In a two-generation oral reproductive test in rats (OECD TG416), a decreased number of live pups on postnatal days 1 - 4 was observed at doses that were not parental toxic (EU-RAR No. 48 (2004)). Based on this data, the substance was classified into Category 1B.
8 Specific target organ toxicity - Single exposure Category 1 (blood, liver), Category 3 (respiratory tract irritation) Danger
Warning
H370: Causes damage to organs (blood, liver)
H335: May cause respiratory irritation (respiratory tract irritation)
P307+P311: IF exposed: Call a POISON CENTER or doctor/physician.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P321: Specific treatment (see ... on this label).
P405: Store locked up.
P501: Dispose of contents/container to ...
P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
There is a case report of a child who showed "jaundice, hemolytic anemia and hemoglobinuria" following ingestion of the substance (Hazard Assessment Report (CERI, NITE) (2006)). In addition, occurrence of "rhinitis" in a woman (exposure route is not clear) is reported (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 76 (2005)). There is a report that "the particle or vapour can cause painful irritations of the eyes and nose" (PATTY (5th, 2001)). Based on the data, the substance was classified into Category 1 (blood system, liver) and Category 3 (respiratory tract irritation).
9 Specific target organ toxicity - Repeated exposure Category 1 (respiratory system, liver, nervous system, blood), Category 2 (kidney) Danger
Warning
H372: Cause damage to organs through prolonged or repeated exposure (respiratory system, liver, nervous system, blood)
H373: May cause damage to organs through prolonged or repeated exposure (kidney)
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ...
In humans, yellow atrophy of the liver, jaundice, neurologic symptoms (ataxia, conduct disorder, memory impairment and language disorder) and anemia are reported following vapour exposure (Hazard Assessment Report (CERI, NITE) (2006)) and severe hypochromic microcytic anemia is reported following oral exposure (PATTY (5th, 2001)). In animal tests, pulmonary effects (interstitial edema, congestion, and alveolar hemorrhage) were observed in rats and guinea pigs following inhalation exposure for 16 days at dose levels within the guidance value range for Category 1 (ATSDR (2006)). In a 4-week oral test with rats, tubular nephropathy with cellular necrosis and dilated tubules appeared at a dose of 150 mg/kg (90-day equivalence: 46.7 mg/kg) and centrilobular hepatocellular hypertrophy appeared at a dose of 300 mg/kg (90-day equivalence: 93.3 mg/kg) (EU-RAR No. 48 (2004)). Effects on the liver and kidney are also reported in an 1-year oral test in dogs, where hyperplasia in the bile duct, portal inflammation in the liver and discoloration and collecting duct vacuolization in the kidney were observed (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 76 (2005)). The respiratory tract, liver, nervous system, blood system and kidney are considered to be target organs. Effects on the liver in animals were noted at dose levels within the guidance value range for Category 2. Based on the data, the substance was classified into Category 1 (respiratory system, liver, nervous system, blood system) and Category 2 (kidney).
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 1 Warning H400: Very toxic to aquatic life P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ...
Classified into Category 1 from its 48h-EC50 = 0.7 mg/L for Crustacea (Daphnia magna) (Initial Risk Assessment Report (NITE, CERI, NEDO), 2005, etc).
11 Hazardous to the aquatic environment (Long-term) Category 1 Warning H410: Very 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 1 since its acute toxicity is Category 1 and it is not rapidly degradable (Non-biodegradable, BOD degradation rate: 0% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 2001)).
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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