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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	72-43-5
Chemical Name	1,1,1-Trichloro-2,2-bis(4-methoxyphenyl)ethane (Methoxychlor)
Substance ID	H30-B-007-MHLW, MOE
Classification year (FY)	FY2018
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)	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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	- -	-	-	It is described that it is combustible (ICSC (1999) (J)), but the classification is not possible due to no data.
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 and oxygen (but not fluorine) which are chemically bonded only to carbon or hydrogen.
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available. Besides, there is information that it is slightly corrosive to iron and aluminum (HSDB (Accessed Jul. 2018)).

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1)-(4), it was classified as "Not classified" (Category 5 in UN GHS classification or corresponds to "Not classified"). The category was changed from the previous classification according to the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) LD50 values for rats: 3,460-7,000 mg/kg (ATSDR (2002), MAK/BAT (2014)) (2) LD50 value for rats: 5,000 mg/kg (ACGIH (1992)) (3) LD50 value for rats: 6,000 mg/kg (ACGIH (1992)) (4) LD50 values for rats: 5,000-7,000 mg/kg (IARC (1979))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	[Rationale for the Classification] Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Not applicable	- -	-	-	[Rationale for the Classification] Solid (GHS definition)
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
2	Skin corrosion/irritation	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Although information (1) indicating that this substance is not skin sensitizing was also obtained, adequate evidence was not obtained to judge as "Not classified." Therefore, it was classified as "Classification not possible." [Reference Data, etc.] (1) There is a description that this substance shows little or no skin sensitization (ACGIH (7th, 2001)).
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] From (1) and (2), it was classified as "Classification not possible" in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) As for in vivo, there are reports of being negative in a mouse dominant lethal test (IARC 20 (1979)), and negative in chromosomal aberration tests with mouse bone marrow cells and spermatogonial cells (MAK/BAT (2014), ATSDR (2002), ACGIH (1992), IRIS (1988), IARC 20 (1979)). (2) As for in vitro, bacterial reverse mutation tests were negative (MAK/BAT (2014), ACGIH (1992), IRIS (1988), IARC (1979)), gene mutation tests with cultured mammalian cells were positive or negative, a UDS test was negative (MAK/BAT (2014), ATSDR (2002 California), IRIS (1988)), and mouse lymphoma assays were positive or negative (ATSDR (2002), ACGIH (7th, 2001)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] There are no reports available in humans for carcinogenicity. From (1)-(4), it was classified as "Classification not possible." [Evidence Data] (1) After a commercial product of this substance (purity: 95% or more) was administered by feeding to rats at two doses of the low dose (448 ppm (males), 750 ppm (females)) or the high dose (845 ppm (males), 1,385 ppm (females)) for 78 weeks, the animals were slaughtered and necropsied after a 34-week observation period. A dose-related decreased body weight gain was observed, but there was no increase in the incidence of tumors, and it was concluded that this substance did not show carcinogenicity (NTP TR35 (1978)). (2) After a commercial product of this substance (purity: 95% or more) was administered by feeding with mice at two doses of the low dose (1,746 ppm (males), 997 ppm (females)) or the high dose (3,491 ppm (males),1,994 ppm (females)) for 78 weeks, the animals were slaughtered and necropsied after a 15-week observation period. A dose-related decreased body weight gain was observed, but there was no increase in the incidence of tumors, and it was concluded that this substance did not show carcinogenicity (NTP TR35 (1978)). (3) In addition to the results of the studies of (1) and (2), IARC summarized the results of multiple studies by oral administration with rats, pointed out that hepatocarcinogenicity observed in the early studies was not confirmed in later studies, and concluded that there is no evidence that this substance is carcinogenic in experimental animals (IARC 20 (1979)). (4) As for classification results by domestic and international organizations, it was classified in Group 3 by IARC (IARC Suppl. 7 (1987)), in A4 by ACGIH (ACGIH (7th, 2001)), and as D by EPA (IRIS (2003)).
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] From (1), effects on fertility in the next generation were observed at doses where general toxicity and reproductive effects (decreased sperm counts and reproductive organs weight, decreased fertility index) were observed in maternal animals. On the other hand, this substance possesses estrogenic effects, and it is considered that effects on sexual function and fertility observed in female and male animals are likely to be applicable to humans from the viewpoint of endocrine mediated mechanisms such as estrogenic effects (ATSDR (2002)). Therefore, it was judged as reasonable to classify in category 1B. The category was changed because data were newly obtained from the information source in List 1. [Evidence Data] (1) In a 2-generation reproductive toxicity study with rats, decreased body weight gain and decreased food consumption were observed in both sexes of parental animals by the administration of 500 ppm or above, decreases in the sperm counts and reproductive organ weights in males, and prolonged estrous cycles and decreases in fertility index and in ovary weights in females were observed. Also in F1 pups, effects on fertility were similarly observed by the administration of 500 ppm or above (MAK/BAT (2014)). [Reference Data, etc.] (2) In a developmental toxicity test in which rats were administered by gavage from postnatal day 21 to sexual maturity, by administration of 25 mg/kg/day, earlier vaginal opening of females and increased FSH and TSH levels, and by administration of 50 mg/kg/day, decreased epididymal weight, decreased sperm counts, etc. in males are reported (MAK/BAT (2014), ATSDR (2002)). (3) In a study in which male rats were administered from gestational day 14 to postnatal day 42 (exposed via maternal animals until weaning, directly exposed after weaning), decreased testis weights of males, etc. are reported (MAK/BAT (2014), ATSDR (2002)).
8	Specific target organ toxicity - Single exposure	Category 2 (nervous system)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	[Rationale for the Classification] From (1), it was classified in Category 2 (nervous system). Besides, the human case in (2) was not used for classification since it was a case of only one person. [Evidence Data] (1) In a single oral dose test in which 1,000 mg/kg (within the range of Category 2) was administered to rats, effects on the nervous system such as tremors, dyspnea, convulsions, and paralysis were observed (ATSDR (2002)). [Reference Data, etc.] (2) As for humans, there is a case report that a 62-year-old man who ingested 125 mL of a commercial preparation containing 15 mg of this substance, showed no response to pain and verbal stimuli, resulting in decreased blood pressure, increased pulse rate, pale skin and profuse sweating (ATSDR (2002)).
9	Specific target organ toxicity - Repeated exposure	Category 2 (nervous system, liver, endocrine system, genetic organs)	Warning	H373	P260 P314 P501	[Rationale for the Classification] Based on (1)-(3), since it was decided that the adrenal gland is included in the endocrine system organs, it was classified in Category 2 (nervous system, liver, endocrine system, genetic organs). Besides, a new information source was added to information sources in the previous classification, and the target organ was reviewed. [Evidence Data] (1) In a 28-day study with rats dosed by gavage, in males, atrophy of the acinus of the breast at or above 20 mg/kg/day (converted guidance value: corresponds to 6.7 mg/kg/day, within the range of Category 1), atrophy of the epididymis, prostate, seminal vesicle, coagulating gland at or above 100 mg/kg/day (converted guidance value: corresponds to 31 mg/kg/day, within the range of Category 2), in females, abnormal sexual cycle, decreased serum luteinizing hormone, effects on the ovary (decreased weight, atrophy of the ovary due to decrease in the number of follicles and corpora lutea), proliferation of acinus of the breast, and hypertrophy of the endometrial epithelium and vaginal epithelium at or above 100 mg/kg/day were observed. In both males and females, hypertrophy of hepatocytes and adrenal gland cells, and elevation of serum triiodothyronine were observed at or above 100 mg/kg/day (MAK/BAT (2017)). (2) There is a report that in a test in which 1,000 ppm of this substance was administered by feeding to rats for 27 months, decreased weight, hydropic degeneration, necrosis and congestion in the liver were observed (IRIS (2003)). (3) There is a report that in a 2-year study with dogs dosed by feeding, tremors and convulsions were observed at or above 2,000 mg/kg/day within the range of Category 2 (IARC (1979)).
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.

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 96-hour EC50 (behavior) = 0.0018 mg/L for crustacea (Asellus communis) (ECETOC TR91: 2003).
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 because it is not rapidly degradable, and 140-day NOEC (lethal) = 0.023 mg/L for fish (Cyprinodon variegatus) (ECETOC TR91: 2003). Data in the species cannot be used for classification originally because it is ovoviviparous. However, the data were used because the lethal effects of the substance were large, and toxicity of similar or more than that is expected for other fish species. For a trophic level for which chronic toxicity data are not obtained (for algae), acute toxicity data were not obtained, therefore, the classification is not possible. From the above results, it was classified in Category 1.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.

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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