NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	8001-35-2
Chemical Name	Toxaphene
Substance ID	m-nite-8001-35-2_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Not classified	- -	-	-	Not combustible (HSDB (2005))	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Not classified	- -	-	-	Not combustible (HSDB (2005))	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Not classified	- -	-	-	Not combustible (HSDB (2005))	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (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)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing chlorine (but not oxygen or fluorine) in the molecule, which is chemically bonded only to carbon.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Category 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	Seven LD50 values for rats of 80, 90, 80 mg/kg (ATSDR (1996)), 293, 220 mg/kg (IARC 79 (2001)), 60 and 120 mg/kg (EHC 45 (1984)) were reported, and all of them corresponded to Category 3.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P361+P364 P280 P312 P321 P405 P501	As for rats, the LD50 value of 1075 mg/kg (male) and 780 mg/kg (female) were reported (ATSDR (1996)). Therefore, Category 3 was adopted taking the greater hazard. As for rabbits, based on the LD50 value of 1025 - 1075 mg/kg (EHC 45 (1984)), Category 4 was adopted. Selecting the category derived from the rat data with greater hazard, the substance was classified as Category 3.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Category 3	Danger	H331	P304+P340 P403+P233 P261 P271 P311 P321 P405 P501	Based on the rat LC50 value (dust) of 3.4 mg/L/1hr = 0.85 mg/L/4hrs (ATSDR (1996)), the substance was classified as Category 3. It was described in the source document that the test condition was dust (ATSDR (1996)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Not classified	- -	-	-	In the 4-hour rabbit test, application of 500 mg of the substance caused only mild irritation (ATSDR (1996)). And in human cases, acute exposure of the substance did not cause irritation. Based on these documents, the substance was classified as "Not classified" in the JIS classification (corresponding to Category 3 in the UN-GHS classification). As relevant information, the substance was classified as "Xi; R37/38" in the EU classification (EU-Annex 1 (Access on May 2009)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	Insufficient data were available. As relevant information, mild irritation of the eyelids was observed after 14 times applications to the eyes of guinea pigs, and eyes were not affected (ATSDR (1996)). However, it is the only summary of an unpublished report, and it was described that the validity of the examination containing protocol and data could not be evaluated (ATSDR (1996)). Therefore, the data were not adopted for the basis for classification.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Not classified	- -	-	-	The substance was classified as "Not classified" based on the negative results in the dominant lethal test using mice orally or intraperitoneally administered (in vivo inheritable mutagenicity test in germ cells) (DFGMAK-Doc. 19 (2003)). As relevant information for the human case, the incidence of chromosomal aberration in peripheral blood lymphocytes of eight women who were working in the area where this substance was sprayed by airplane was 13.1% in comparison with 1.6% of the control group (IARC 79 (2001)). However, it was unclear whether the cause of these cases depended on the direct effects of this substance (ATSDR (1996)). As for in vitro studies, positive results in the Ames test and negative results in the HPRT test using Chinese hamster V79 cells were reported (IARC 79 (2001)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	The substance was classified as Category 2 based on the carcinogenicity criteria of "Group 2B" in the IARC (IARC 79 (2001)), "A3" in the ACGIH (ACGIH (2001)), and "Category 3" in the EU (EU-Annex 1 (Access on May 2009)). As relevant information, in the 80-week dietary tests using rats and mice, the increases in the incidences of thyroid tumors in rats and hepatocellular carcinomas in mice were reported (NTP TR37 (1979)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Not classified	- -	-	-	In the three-generation study (EHC 45 (1984)) or two-generation study (DFGMAK-Doc.19 (2003)) by oral administration in rats, no effects on sexual functions, reproductive performance, fertility, and lactation were observed at the dose levels that cause general toxicity in parental animals. In addition, five generation study by oral administration in mice (IARC 79 (2001)), no embryotoxic or teratogenic effects were observed. Furthermore, in the oral administration studies using rats or mice during the organogenetic period, increase in the incidence of extra ribs in rats, and increase in the incidence of encephalocele in mice were reported (IARC 79 (2001)). However, since these effects were observed only at the high dose level that maternal deaths were produced, the observation of the study was not adopted as the basis for classification. In these studies administered during the organogenetic period, other effects containing teratogenicity were not reported (IARC 79 (2001)). Therefore, since in these multi generation studies and developmental toxicity studies in rats or mice, no adverse effects were observed, the substance was classified as "Not classified".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	As the acute poisoning symptoms after ingestion of the substance in humans, clinical signs such as involuntary jerking movements of the extremities, muscle spasms, nausea and vomiting appeared (DFGMAK-Doc. 19 (2003)), and convulsions occurred in all patients, regardless of survival or death (ACGIH (2001), DFGMAK-Doc. 19 (2003)). Moreover, there was a description stating that the substance induced general stimulation of the central nervous system (ACGIH (2001)). Furthermore, it was also reported that signs such as clonic-tonic convulsions, salivation, vomiting and hyperreflexia, etc. were observed in the acute inhalation study in mice exposed at 20 mg/m3 over 2 hours (converted value as that of 4h-exposure: 0.01 mg/L) (ACGIH (2001)). Based on the above findings, the substance was classified as Category 1 (central nervous system).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver, kidney, thyroid), Category 2 (central nervous system)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	In the 13-week feeding study in rats (4, 20, 100 and 500 mg/kg diet; 0.4, 2, 10 and 50 mg/kg bw), severe histopathological changes were noted in the kidneys and the adaptive changes were observed in the liver and thyroid with dose dependency. The focal and severe injuries in the proximal tubules (anisokaryosis and necrosis) in the kidneys were found at 2 mg/kg bw which corresponded to Category 1 of GHS classification. The changes in the thyroid included increased epithelial height by multifocal papillary proliferation and reduced colloid density were observed in males at 2 mg/kg bw which corresponded to Category 1of GHS classification and in females at 50 mg/kg/ bw which corresponded to Category 2 (IARC vol. 79 (2001)). In the 13-week oral dose study in dogs (0.2, 2 and 5 mg/kg bw), increase in alkaline phosphatase activity as well as mild to moderate histopathological changes in the liver, thyroid and kidneys were seen at 5 mg/kg bw which corresponded to Category 1 of GHS classification. Thus, the substance was classified as Category 1 (kidney). Moreover, as the findings in the liver, centrilobular hepatocellular hypertrophy and fatty intracytoplasmic inclusion bodies were observed at dietary concentrations of 50 - 200 ppm (converted values as the actual intake: 5 - 20 mg/kg/day) in the 2 to 9 months feeding study in rats (DFGMAK-Doc. 19 (2003)), and centrilobular hepatocellular hypertrophy and peripheral margination of increase in eosinophilic cells and basophilic granules were observed at dietary concentrations of 100 - 400 ppm (converted values as the actual intake: 5 - 20 mg/kg/day) in the life-time feeding study in rats (EHC 45 (1984)). Since these changes were observed from the dose range equivalent to Category 1, the substance was classified as Category 1 (liver). Furthermore, as the thyroids, significant increase in TSH (thyroid stimulating hormone) was found in the oral administration study in rats administered at 100 mg/kg bw for three days and thereafter at 75 mg/kg bw for 25 days (IARC vol. 79 (2001)), and increased epithelial height by multifocal papillary proliferation and reduced colloid density in the thyroid were observed in males at 2 mg/kg bw which corresponded to Category 1 of GHS classification (IARC vol. 79 (2001)). Thus, the substance was also classified as Category 1 (thyroid). Otherwise, there was the description that toxic signs such as generalized body tremors, leg paralysis and ataxia, etc. were observed at higher dose levels (1080 - 1112 ppm, converted values as the actual intake: approx. 55 mg/kg/day, equivalent to Category 2) in the 80-week feeding study in rats (NTP TR 37 (1979)). Therefore, the substance was additionally classified as Category 2 (central nervous system).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Category 1	Warning	H400	P273 P391 P501	Classified into Category 1 from its 96h-LC50 = 0.0011 mg/L for fish (Cyprinodon variegatus) (EHC 45, 1984).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Classified into Category 1 since its acute toxicity is Category 1 and it is estimated not to be rapidly degradable (BIOWIN).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

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.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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