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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	50471-44-8
Chemical Name	(RS)-3-(3,5-Dichlorophenyl)-5-methyl-5-vinyl-1,3-oxazolidine-2,4-dione (Vinclozolin)
Substance ID	H30-B-008-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	FY2008
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	- -	-	-	No data available.
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There is a chemical group associated with self-reactive properties (ethylene group) present in the molecule, but the classification is not possible due to no data.
9	Pyrophoric liquids	Not applicable	- -	-	-	Solid (GHS definition)
10	Pyrophoric solids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures because it is stable at 50 deg C (HSDB (Accessed Jul. 2018)).
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.

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) and (2), it was classified as "Not classified." [Evidence Data] (1) LD50 value for rats: >10,000 mg/kg (EPA Pesticide (2000)) (2) LD50 value for rats: 15,000 mg/kg (JMPR (1995))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) LD50 value for rats: >2,500 mg/kg (EPA Pesticide (2000)) (2) LD50 value for rats: >5,000 mg (JMPR (1995))
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. Besides, the exposure time of (1) is unknown, and it cannot be used for classification. [Evidence Data] LD50 value for rats: >29 mg/L (EPA Pesticide (2000), JMPR (1995))
2	Skin corrosion/irritation	Classification not possible	- -	-	-	[Rationale for the Classification] Although there is data (1) showing irritation, it is a 24-hour application test, and no information was obtained other than this. Therefore, it was classified as "Classification not possible" due to lack of data. [Reference Data, etc.] (1) There is a report that in a skin irritation test with rabbits, the substance was applied for 24 hours and 5/6 animals showed definite erythema, one of which showed slight edema, and the animals recovered after 72 hours. (JMPR (1995), EPA Pesticide (2004)).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] Although the details of the test in (1) are not known, it was classified as "Not classified" based on the judgment of JMPR on the basis of the weight of evidence. [Evidence Data] (1) There is a report that in an eye irritation test with rabbits, as a result of application of this substance, slight conjunctival redness was observed after 24 hours and did not resolve within 72 hours. However, JMPR judged as "not irritating to the eyes" (JMPR (1995)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] Based on (1), it was classified in Category 1. [Evidence Data] (1) There is a report that when this substance was applied in a Maximization test (n=12 (male)) with guinea pigs, clear sensitization was observed (JMPR (1995)). [Reference Data, etc.] (2) This substance was classified as "Skin Sens. 1" by EU CLP.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (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, it was negative in a dominant lethal test with male mice (JMPR (1995)), comet assay, a micronucleus test (NTP DB (Accessed Jul. 2018)), and a sister chromatid exchange test with male and female hamsters (JMPR (1995)). (2) As for in vitro, negative results are reported in bacterial reverse mutation tests, DNA repair tests with Bacillus subtilis, gene mutation tests, a chromosomal aberration test and an unscheduled DNA synthesis test with mammalian cultured cells (JMPR (1995)). [Reference Data, etc.] (3) It is also concluded in JMPR (1995) that it is not genotoxic.
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] As for carcinogenicity, there are no available reports in humans. Based on the animal test results in (1) and (2), and classifications by other organizations in (3), it was classified in Category 2. [Evidence Data] (1) In a carcinogenicity study in which male and female rats were orally administered (feeding) at 150-4,500 ppm for 2 years, tumors of the Leydig cells at 150 ppm, benign stromal tumors of the sex cord in the ovary at 500 ppm in females, adrenal tumors at 1,500 ppm in females, and hepatocellular carcinomas at 4,500 ppm in males were observed (JMPR (1995)). (2) In a carcinogenicity study in which male and female rats were orally administered (feeding) at 50-3,000 ppm for 2 years, adenocarcinomas of the uterus were observed at 3,000 ppm in females. And in an 18-month study in which male and female mice were orally administered, hepatocellular carcinomas were observed at 8,000 ppm (JMPR (1995)). (3) As for classification results by domestic and international organizations, it was classified as Group C by EPA (EPA Pesticide (2000)) and in Carc. 2 by EU CLP.
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] From (1) and (2), developmental effects including malformations were observed in male pups as significant effects at or below the doses where maternal toxicity was manifested. Therefore, it was classified in Category 1B. [Evidence Data] (1) In a multigeneration study with rats, male sterility due to feminization of the outer genital organs in pups, was observed by the administration of 1,000 ppm, and a possibility of reduced fertility was suggested by the administration of 300 ppm. In F2 pups, decreased epididymal weight was observed by the administration of 50 ppm (JMPR (1995)). (2) In a developmental toxicity study with pregnant rats, reduced anogenital distance (AGD) were observed at lower doses than the dose where maternal toxicity was manifested (JMPR (1995)). [Reference Data, etc.] (3) By the administration of lower dose levels (at or above 3 mg/kg/day) to rats, androgen-dependent organs and functions were affected by androgen receptor inhibition, and effects such as decreased prostate weight of male rats, decreased weights of other reproductive organs, development of nipple/areolas processes, and effects on AGD were significantly observed. In addition, by the administration of higher dose levels, a further decrease in genital weight, malformations such as ectopic testes and vaginal pouches were observed (EPA Pesticide (2000)). (4) In a developmental toxicity test with rabbits, by the administration of 800 mg/kg/day, increased mortality rate was observed, but no teratogenicity was observed (JMPR (1995)). (5) It was classified in "Repr. 1B" by EU CLP.
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
9	Specific target organ toxicity - Repeated exposure	Category 1 (visual organs), Category 2 (adrenal gland, genetic organs (men))	Danger Warning	H372 H373	P260 P264 P270 P314 P501	[Rationale for the Classification] Although lesions of the eyes in (7) were observed as effects only in rats, the visual organs were regarded as target organs, because there were plural reports and the dose at which the findings were exhibited was smaller than the guidance value of Category 1. Therefore, male genitalia including the testis, visual organs and the adrenal glands were adopted as target organs for this substance. Therefore, it was classified in Category 1 (visual organs), Category 2 (adrenal gland, genetic organs (men)). Besides, as for the effects on the thyroid and spleen, since severe tissue changes were not described, it was considered to be not serious effects. Because the findings with the kidney in (4) were not observed in (5) of longer-term, and as for findings in the liver in (3), similar findings were not observed in (7) of longer-term and higher doses, these organs were excluded from the target organs. The data of IRIS (1992) used as evidence information in the previous classification were not confirmed and the classification was reviewed using the new information source, and the target organs and category were changed. [Evidence Data] (1) There are reports that in two studies in which mice were administered by feeding for three months, the findings of hepatotoxicity, the findings related to anti-androgen activity, and changes of the adrenal gland were observed at or above 100 ppm (20 mg/kg/day, within the range of Category 2) (JMPR (1995)). (2) There are reports that in 3-month feeding studies with rats, an effect on the adrenal glands (lipidosis) was observed at or above 300 ppm (equivalent to 15 mg/kg/day, within the range of Category 2) in addition to similar effects as (1) (JMPR (1995)). (3) There is a report that in a study with rats dosed by feeding for 3 months, hypertrophy of the adrenal cortex, cystoid degeneration in the pituitary, Leydig-cell hyperplasia, cloudy swelling of hepatocytes, single cell necrosis, vacuolization of luteal cells in the ovary, etc. were observed at or above 1,000 ppm (converted guidance value: 73 mg/kg/day, within the range of Category 2) (JMPR Part II (1995)). (4) There is a report that in a study with dogs dosed by feeding for 6 months, an increase in adrenal gland weights at 300 ppm (7.5 mg/kg/day, within the range of Category 1), vacuolation of the zona fasciculata of the adrenal grands (female), and increased fatty droplets of distal tubules of the kidney (male) at or above 600 ppm (15 mg/kg/day, within the range of Category 2) were observed (IRIS (2002)). (5) There is a report that in a study with dogs dosed by feeding for 12 months, increases in tissue weights and other effects were observed in the thyroid, liver, spleen, prostate, testis, and adrenal glands at or above 150 ppm (3.75 mg/kg/day, within the range of Category 1), but no clinical signs were observed (JMPR Part II (1995)). (6) There is a report that in a carcinogenicity study with mice, hepatotoxicity, Leydig-cell hyperplasia, atrophic uteri, and lipidosis in the cortico-medullary region of the adrenal glands were observed at 3,000 ppm exceeding Category 2 (JMPR (1995)). (7) Cataract and other lens lesions were observed at or above 50 ppm (2.5 mg/kg/day, within the range of Category 1) in a long-term study with rats, but eye lesions were not observed in mice and dogs (JMPR (1995)). Besides, also in a two-year feeding study with rats, nuclear degeneration and calcification of the lens were observed at 150 ppm (7.5 mg/kg/day, within the range of Category 1) (JMPR (1995)). In addition, there is a report that no liver damage was observed even at a dose of 3,000 ppm in a two-year feeding study with rats (JMPR Part II (1995)).
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 2	- -	H401	P273 P501	It was classified in Category 2 from 96-hour LC50 = 1.8 mg/L for crustacea (Americamysis bahia) (NLM HSDB: 2018, EPA AQUIRE: 2018, EPA Pesticide Ecotoxicity Database (1992)).
11	Hazardous to the aquatic environment (Long-term)	Category 1	Warning	H410	P273 P391 P501	It was classified in Category 1 because it is not rapidly degradable, and 175-day NOEC (hatching, growth, survival) = 0.05 mg/L for fish (Pimephales promelas) (EPA AQUIRE: 2018, EPA Pesticide Ecotoxicity Database Agency (1992)).
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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