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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	50-32-8
Chemical Name	Benzo[a]pyrene
Substance ID	23B5503
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	- -	-	-	There is information that it is combustible (ICSC (J) (2005)), but there are no data in the prescribed test.
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	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine.
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)	Classification not possible	- -	-	-	An LD50 value for mice is reported to be > 1,600 mg/kg (EHC 202 (1998)), but the category cannot be determined. Therefore, the classification is not possible.
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. Besides, it is described that it can cause a rash and burning sensations in the skin (HSDB (2010)), but no detailed data are mentioned.
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available. Besides, it is described that eye contact can cause irritations and burns (HSDB (2010)), but no detailed data are mentioned.
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.
4	Skin sensitization	Classification not possible	- -	-	-	Data are lacking. Besides, positive reactions were reported in skin sensitization tests in guinea pigs and mice (adjuvant and patch test and mouse ear swelling test, respectively) (EHC 202 (1998)). However, these were not used for classification because each used the test method that was not approved by OECD, and a positive rate is unknown.
5	Germ cell mutagenicity	Category 1B	Danger	H340	P308+P313 P201 P202 P280 P405 P501	It was classified in Category 1B based on a positive result in a dominant lethal test with mice (in vivo heritable germ cell mutagenicity test) (EHC 202 (1998)). Besides, it is reported that a mutual translocation test with mice (in vivo heritable germ cell mutagenicity test) was negative (EHC 202 (1998)), but as in vivo somatic cell mutagenicity tests, multiple chromosomal aberration tests with mouse bone marrow were all positive, a mouse spot test was positive, and a micronucleus test was also positive (EHC 202 (1998), NTP DB (Access on Aug. 2010)). Furthermore, as for in vivo somatic cell genotoxicity tests, a sister chromatid exchange test with mammal bone marrow cells and a DNA binding test and a DNA adduct formation test with mammal somatic cells gave all positive results (EHC 202 (1998), NTP DB (Access on Aug. 2010)). On the other hand, as for in vitro tests, mostly positive results were reported in Ames tests, and gene mutation tests and chromosomal aberration tests with cultured mammal cells (EHC 202 (1998), NTP DB (Access on Aug. 2010)).
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 92 (2010)). Besides, it was classified in 2A by the Japan Society for Occupational Health (JSOH) (Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), 2010)), B2 by EPA (IRIS (1998)), A2 by ACGIH (ACGIH (7th, 2001)), R by NTP (NTP ROC 12th (2011)), and Category 2 by the EU (EC-JRC (ESIS) (Access on Aug. 2011)). Furthermore, this substance caused tumors in several different organs in several different exposure routes in eight animal species, including nonhuman primates (NTP ROC 12th (2011)). For example, in a 2-year diet administration test with female mice, incidences of squamous cell papillomas and carcinomas in the esophagus, tongue, and forestomach significantly increased, and in a lifetime inhalation exposure test with hamsters, papillomas, polyps, and squamous cell carcinomas were found in the upper respiratory tract and upper gastrointestinal tract, and in a test in which female rats were given 8-week oral administration followed by 41-week observation, the incidence and total number of mammary gland tumors markedly increased (IARC 92 (2010)).
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	In a test by oral administration to mice on gestational days 7-16 (doses: 0, 10, 40, 160 mg/kg), significant decreases in gestation index and delivery index were observed in the 160 mg/kg/day group, and as a result of breeding by mating F1 males and females obtained in each group with untreated males and females, the pairs at or above 10 mg/kg/day showed significant decreases in gestation index, F1 females were infertile at or above 40 mg/kg/day, and F1 males were infertile at 160 mg/kg/day. The gonad was markedly small, testis weight was lower, the seminiferous tubules atrophied in F1 at or above 10 mg/kg/day, and the 40 mg/kg/day group had no semen. Also, in F1 females, ovaries were missing or rudimentary in most of them, and the 40 mg/kg/day group had no signs of follicle formation (Environmental Risk Assessment for Chemical Substances vol. 5 (Ministry of the Environment, 2006)). Stillbirths are reported after oral administration to rats during pregnancy (PATTY (5th, 2001)). From the above knowledge, although there were no descriptions of general toxicity in parent animals, adverse reproductive effects were observed, and the substance was classified in Repr. Cat.2; R60-R61 in EU classification. Therefore, it was classified in Category 1B.
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	No data available.
9	Specific target organ toxicity - Repeated exposure	Category 2 (hematopoietic system)	Warning	H373	P260 P314 P501	In a 90-day gavage administration test with male rats, significant decreases in erythrocyte counts, hemoglobin level, hematocrit value, and B cell percentage in the spleen were seen at or above 10 mg/kg/day, and at 90 mg/kg/day, in addition to decreased lymph node weight, significant decreases in leukocyte counts, bone marrow cells, natural killer cells in the spleen were observed. Decreases in erythrocyte counts, hemoglobin level, and hematocrit value were also seen at or above 50 mg/kg/day in a 90-day diet administration test with rats (Environmental Risk Assessment for Chemical Substances vol. 5 (Ministry of the Environment, 2006)). On the other hand, in a test in which two strains of mice having genetically different metabolizing enzyme activities (responsive and nonresponsive) were given 3-week oral administration of 120 mg/kg/day (converted guidance value: 28 mg/kg/day), no myelotoxicity was observed in responsive mice, but myelotoxicity (aplastic anemia, pancytopenia) occurred in nonresponsive mice, and all the animals died within three weeks, which was reported to be adverse hematopoietic effects (ATSDR (1995)). Because the doses of the above findings corresponded to the guidance value range for Category 2, it was classified in Category 2 (hematopoietic system).
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 72-hour EC50 = 0.005 mg/L for algae (Scenedesmus acutus) (Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006), etc.).
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 (BIOWIN), and 36-day NOEC = 0.0024 mg/L for fish (Oncorhynchus mykiss) (EHC 202, 1998). 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 (BIOWIN), and 72-hour EC50 = 0.005 mg/L for algae (Scenedesmus acutus) (Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006), etc.). 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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