NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	1309-37-1
Chemical Name	Diiron trioxide
Substance ID	R01-B-042
Classification year (FY)	FY2019
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)
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	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified (Not applicable)."
2	Flammable gases	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
3	Aerosols	*	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."
4	Oxidizing gases	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
5	Gases under pressure	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
6	Flammable liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
7	Flammable solids	*	- -	-	-	It was classified as "Not classified" from information that it is not combustible (ICSC (2004)).
8	Self-reactive substances and mixtures	*	- -	-	-	There are no chemical groups associated with explosive or self-reactive properties present in the molecule. It was classified as "Not classified (Not applicable)."
9	Pyrophoric liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
10	Pyrophoric solids	*	- -	-	-	It was classified as "Not classified" from information that it is not combustible (ICSC (2004)).
11	Self-heating substances and mixtures	*	- -	-	-	It was classified as "Not classified" from information that it is not combustible (ICSC (2004)).
12	Substances and mixtures which, in contact with water, emit flammable gases	*	- -	-	-	It is a metal compound, but it was classified as "Not classified" because it is estimated that it does not react vigorously with water from information that it is insoluble in water (ICSC (2004)).
13	Oxidizing liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
14	Oxidizing solids	*	- -	-	-	It is an inorganic compound containing oxygen (but not halogen). However, the classification is not possible due to no data.
15	Organic peroxides	*	- -	-	-	Inorganic compound. It was classified as "Not classified (Not applicable)."
16	Corrosive to metals	*	- -	-	-	Classification is not possible because test methods applicable to solid substances are not available.
17	Desensitized explosives	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: > 15,000 mg/kg (JECFA FAS6 (1975)) (2) LD50 for rats: > 10,000 mg/kg (HSDB (Access on July 2019)) [Reference Data, etc.] (3) LD50 for mice: > 15,000 mg/kg (JECFA FAS6 (1975))
1	Acute toxicity (Dermal)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Gases)	*	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified (Not applicable)."
1	Acute toxicity (Inhalation: Vapours)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	*	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) Inhalation exposure with rats (4 hours, dust) : no death at more than 5.05 mg/L (REACH registration dossier (Access on August 2019))
2	Skin corrosion/irritation	*	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." Besides, the classification was changed using the new data obtained. [Evidence Data] (1) In a skin irritation test with rabbits conducted according to OECD TG 404 (4-hour semi-occlusive application), no skin reaction was observed, and the mean scores for erythema and edema were 0 for 24/48/72 hours (REACH registration dossier (Access on August 2019)).
3	Serious eye damage/eye irritation	*	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." Besides, since IUCLID (2000), which was the basis for the previous classification, cannot be currently confirmed, the classification was changed based on the new data. [Evidence Data] (1) In an eye irritation test with rabbits conducted according to OECD TG 405, it was reported that the irritation score at 24/48/72 hours was 0, indicating no irritation (REACH registration dossier (Access on August 2019)). [Reference Data, etc.] (2) In an eye irritation test with rabbits conducted according to OECD TG 405 (but with an application volume of 30 mg), it was reported that the irritation score at 24/48/72 hours was 0, indicating no irritation (REACH registration dossier (Access on August 2019)).
4	Respiratory sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	*	- -	-	-	[Rationale for the Classification] There is data of (1), however, classification was not possible due to lack of data. [Evidence Data] (1) In a skin sensitization test with guinea pigs (Maurer optimization test, intradermal induction: 0.1% x 10 injections), no skin reaction was observed and it was concluded to be negative (REACH registration dossier (Access on August, 2019)).
5	Germ cell mutagenicity	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), since negative findings were observed in in vivo and in vitro tests, it was classified as "Not classified." [Evidence Data] (1) As for in vivo, there are negative reports in a comet assay and an unscheduled DNA synthesis test with rats (HSDB (Access on July 2019)). (2) As for in vitro, there are negative reports in bacterial reverse mutation tests and a chromosomal aberration test with cultured mammalian cells (HSDB (Access on July 2019)).
6	Carcinogenicity	*	- -	-	-	[Rationale for the Classification] Based on classification results by other organizations in (1), it was classified as "Classification not possible" in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) 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, 2006)). [Reference Data, etc.] (2) Some studies on metal workers exposed to the dusts of this substance have shown an increased incidence of lung cancer, but the influence of factors other than ferric oxide (soots, silica and asbestos in foundry work) cannot be discounted. In other studies on metal and chemical workers exposed to this substance, the incidence of lung cancer was not increased (IARC Suppl 7 (1987)). (3) No carcinogenic effect due to this substance by itself was observed in tests which mice, hamsters or guinea-pigs were given ferric oxide intratracheally or by inhalation (IARC Suppl 7 (1987), ACGIH (7th, 2006)).
7	Reproductive toxicity	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
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), since it was presumed to be probable that inhalation of this substance causes respiratory symptoms and pulmonary inflammation in humans, it was classified as Category 1 (respiratory organs). By using the new information, the category was changed from the previous classification. [Evidence Data] (1) Fume fever with cold-like symptoms such as fever, chills, pain, chest tightness and coughing may occur due to exposure to the dust or fume of this substance (HSDB (Access on July 2019)). (2) When 10 volunteers were given 5 mg of the particles of this substance (particle size: 2.6 micrometer) by single instillation into the lung with the use of a bronchoscope, a transient inflammatory response (an increased number of neutrophils and alveolar macrophages, and increased amounts of protein, lactate dehydrogenase and interleukin-8 in bronchoalveolar lavage fluid) was observed in the lung (ACGIH (7th, 2006), HSDB (Access on July 2019)). (3) Although the number of exposures was not described, there is a report that 3 men exposed to the welding fumes of this substance developed coughing and shortness of breath, and diffuse fibrosis in the lungs by X-ray examination (HSDB (Access on July 2019)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] Based on (1) and (2), since effects on the lungs in humans were observed on inhalation, it was classified as Category 1 (respiratory organs). [Evidence Data] (1) Inhalation of dust containing this substance causes siderosis (a harmless form of pneumoconiosis) in the lungs (ACGIH (7th, 2006), DFGOT vol.2 (1991)). (2) Six to 10 years of exposure to iron oxide fume is required in order to produce siderosis. Pulmonary siderosis is considered a benign condition and does not progress to fibrosis. Little or no clinical change was found in workers diagnosed with pulmonary siderosis (ACGIH (7th, 2006)). [Reference Data, etc.] (3) A number of workers with exposure to mixed substances containing this substance developed pneumoconiosis. There is a report that workers exposed to iron oxide fume and silica may develop "a mixed dust pneumoconiosis" (ACGIH (7th, 2006)).
10	Aspiration hazard	*	- -	-	-	[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)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	Classification not possible due to lack of data.

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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