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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	108-62-3
Chemical Name	2,4,6,8-Tetramethyl-1,3,5,7-tetraoxacyclooctane (synonym: Metaldehyde)
Substance ID	R03-C-058-MHLW
Classification year (FY)	FY2021
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)
New/Revised	Revised
Classification result in other fiscal year	FY2009
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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	-	- -	-	-	-
2	Flammable gases	-	- -	-	-	-
3	Aerosols	-	- -	-	-	-
4	Oxidizing gases	-	- -	-	-	-
5	Gases under pressure	-	- -	-	-	-
6	Flammable liquids	-	- -	-	-	-
7	Flammable solids	-	- -	-	-	-
8	Self-reactive substances and mixtures	-	- -	-	-	-
9	Pyrophoric liquids	-	- -	-	-	-
10	Pyrophoric solids	-	- -	-	-	-
11	Self-heating substances and mixtures	-	- -	-	-	-
12	Substances and mixtures which, in contact with water, emit flammable gases	-	- -	-	-	-
13	Oxidizing liquids	-	- -	-	-	-
14	Oxidizing solids	-	- -	-	-	-
15	Organic peroxides	-	- -	-	-	-
16	Corrosive to metals	-	- -	-	-	-
17	Desensitized explosives	-	- -	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	-	- -	-	-	-
1	Acute toxicity (Dermal)	-	- -	-	-	-
1	Acute toxicity (Inhalation: Gases)	-	- -	-	-	-
1	Acute toxicity (Inhalation: Vapours)	-	- -	-	-	-
1	Acute toxicity (Inhalation: Dusts and mists)	-	- -	-	-	-
2	Skin corrosion/irritation	-	- -	-	-	-
3	Serious eye damage/eye irritation	-	- -	-	-	-
4	Respiratory sensitization	-	- -	-	-	-
4	Skin sensitization	-	- -	-	-	-
5	Germ cell mutagenicity	-	- -	-	-	-
6	Carcinogenicity	-	- -	-	-	-
7	Reproductive toxicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (4), it was classified as "Not classified." Besides, in the EU, it was classified in Repr. 2 because testis toxicity was observed in a repeated dose toxicity study with dogs based on (5), but since there was no evidence of adverse effects on fertility in test animals, it was not adopted for the classification. [Evidence Data] (1) In a two-generation reproduction toxicity study with rats dosed by feeding (GLP, 50 to 2,000 ppm), no effects on fertility were observed in parent animals up to 2,000 ppm (134 to 164 mg/kg/day) at which hind limb paralysis, spinal fracture/luxation, and hemorrhage/necrosis of the spinal cord were observed in females of the P generation, and increases in absolute and/or relative liver weight were observed in F1 males and females. In offspring, only reduced body weight gain was observed in F1 and F2 female pups (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2018), CLH Report (2016), ECHA RAC Opinion (Background Doc.) (2017)). (2) In a developmental toxicity study (GLP, 25 to 150 mg/kg/day) with female rats dosed by gavage on days 6 to 15 of gestation, no developmental effects were observed in fetuses up to the highest dose (150 mg/kg/day) at which death (6/25 animals), reduced body weight and food consumption, dilated renal pelvis, hydronephrosis, and paravertebral hemorrhages were observed in dams (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2018), CLH Report (2016), ECHA RAC Opinion (Background Doc.) (2017)). (3) In a developmental toxicity study (GLP, 10 to 80 mg/kg/day) with female rabbits dosed by gavage on days 6 to 18 of gestation, no abnormalities were observed both in dams and fetuses up to the highest dose. In a preliminary test for dose settings, deaths were observed in dams at 100 mg/kg/day, and therefore, the highest dose in the test was set to 80 mg/kg/day (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2018), CLH Report (2016), ECHA RAC Opinion (Background Doc.) (2017)). (4) Based on (1) to (3), no effects on fertility nor teratogenicity were observed after administration of this substance (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2017)). [Reference Data, etc.] (5) Based on (1) to (3), no reproduction developmental effects were detected, but in 52-week chronic toxicity studies with dogs, testis toxicity (bilateral localized atrophy of the testis) was observed, which might adversely affect fertility. No testis toxicity was observed in rats, but the possibility of a difference between the species cannot be ruled out. This substance was classified in Repr. 2 by the ECHA RAC (Committee for Risk Assessment of the European Chemical Agency) based on the testis toxicity in chronic toxicity studies with dogs (ECHA RAC Opinion (2017)). (6) In the EU, it was classified in Repr. 2 (EU-CLP Classification Results (Accessed Nov. 2021)).
8	Specific target organ toxicity - Single exposure	-	- -	-	-	-
9	Specific target organ toxicity - Repeated exposure	-	- -	-	-	-
10	Aspiration hazard	-	- -	-	-	-

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
11	Hazardous to the aquatic environment Short term (Acute)	-	- -	-	-	-
11	Hazardous to the aquatic environment Long term (Chronic)	-	- -	-	-	-
12	Hazardous to the ozone layer	-	- -	-	-	-

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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