NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	30525-89-4
Chemical Name	Paraformaldehyde
Substance ID	R03-B-020-METI
Classification year (FY)	FY2021
Ministry who conducted the classification	Ministry of Economy, Trade and Industry (METI)
New/Revised	Revised
Classification result in other fiscal year	FY2018 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 (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	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
7	Flammable solids	Category 2	Warning	H228	P370+P378 P210 P240 P241 P280	It was classified in Category 2 because it is classified in Division 4.1, PG III in UNRTDG (UN2213).
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.
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
10	Pyrophoric solids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 300 deg C (ICSC (2006)).
11	Self-heating substances and mixtures	Not classified	- -	-	-	It is estimated that it does not correspond to self-heating substances and mixtures, hazards of the highest precedence, because it is classified in Division 4.1, PG III in UNRTDG (UN2213). Therefore, it was classified as "Not classified."
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).
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
15	Organic peroxides	Not classified (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.
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	[Rationale for the Classification] Based on (1), it was classified in Category 4. [Evidence Data] (1) LD50 for rats: 800 mg/kg (Canada CMP (2019)) [Reference Data, etc.] (2) Paraformaldehyde, which is a target substance to be classified, is part of a broader group of formaldehyde polymers called poly(oxymethylenes) (POM) and the degree of polymerization lies between 8 and 100 (Canada CMP (2019)).
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." Also, based on the new findings, the classification result was changed. [Evidence Data] (1) LD50 for rabbits: 10,000 mg/kg (Canada CMP (2019))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified."
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Category 4	Warning	H332	P304+P340 P261 P271 P312	[Rationale for the Classification] Based on (1), it was classified in Category 4. [Evidence Data] (1) LC50 (4 hours) for rats: 1.07 mg/L (Canada CMP (2019))
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	[Rationale for the Classification] Based on (1), it was classified in Category 2. [Evidence Data] (1) This substance was a skin irritant (Canada CMP (2019)). [Reference Data, etc.] (2) It was reported that, in a skin irritation test (500 mg, 24-hour application) with rabbits, it was severely irritating to the rabbits' skin (Patty (6th, 2012), GESTIS (Accessed Aug. 2021)).
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2A. [Evidence Data] (1) This substance was an eye irritant (Canada CMP (2019)). (2) It was reported that, in an eye irritation test with rabbits (instillation of 100 mg), it was severely irritating to the eyes (Patty (6th, 2012), GESTIS (Accessed Aug. 2021)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) This substance may be a sensitizer to the respiratory tract (Canada CMP (2019)). (2) This substance becomes a source of free formaldehyde when it is heated, and the most likely health effects for risk characterization are sensory irritation and allergic reaction on skin. Sensory irritation is defined as irritation of the nerve endings in the eyes and nose and can produce symptoms such as stinging or burning sensations in the eyes and nose and a sore throat (AICIS IMAP (2019)).
4	Skin sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) This substance may be a sensitizer to the skin (Canada CMP (2019)). (2) This substance becomes a source of free formaldehyde when it is heated, and the most likely health effects for risk characterization are sensory irritation and allergic reaction on skin. Sensory irritation is defined as irritation of the nerve endings in the eyes and nose and can produce symptoms such as stinging or burning sensations in the eyes and nose and a sore throat (AICIS IMAP (2019)).
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) As for in vitro, in a chromosomal aberration assay using the cultured mammalian cells (CHO), this substance was negative, while in a sister chromatid exchange assay using the CHO and a gene mutation assay using the mouse lymphoma cells, it was positive (Canada CMP (2019)). (2) The results in (1) suggested that this substance was mutagenic and clastogenic. However, there was no information on whether this substance or formaldehyde contributed to these effects (Canada CMP (2019)). (3) Poly(oxymethylenes) of this substance, which has a polymerization number of 100 or higher, is a target substance in the Guidelines for Preventing Health Impairment by Chemical Substances with Mutagenicity Recognized of the Ministry of Health, Labour and Welfare (the Labour Standards Bureau Notification No. 312 dated May 17, 1993).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) Formaldehyde, which is a monomer, is classified in Category 1A for this hazard class (GHS classification result in FY2017).
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) Classification of the monomer for this hazard class is considered not possible due to lack of data (GHS classification result in FY2017).
8	Specific target organ toxicity - Single exposure	Category 1 (respiratory organs)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	[Rationale for the Classification] Based on (1) to (3), it was classified in Category 1 (respiratory organs). [Evidence Data] (1) This substance is a source of free formaldehyde and the most likely health effects for risk characterization are sensory irritation and allergic reaction on skin. Sensory irritation is defined as irritation of the nerve endings in the eyes and nose and can produce symptoms such as stinging or burning sensations in the eyes and nose and a sore throat (AICIS IMAP (2019)). (2) Inhalation exposure to this substance can irritate the lungs causing coughing and shortness of breath. Exposures at higher concentrations can cause pulmonary edema and severe shortness of breath (HSFS (2000)). (3) It was reported that, in an acute inhalation exposure test with rats (1.07 mg/L, 4 hours), symptoms of irritation (lacrimation, salivation, difficulty in breathing) were observed at 1.07 mg/L (within the range for Category 2) (GESTIS (Accessed July 2021)). [Reference Data, etc.] (4) It was reported that, in an acute dermal toxicity test with rabbits, somnolence, corrosive effects on skin, and decreased body temperature were observed at 10,000 mg/kg (Patty (2012)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
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 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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