GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 102-54-5
Chemical Name Dicyclopentadienyl iron; Ferrocene
Substance ID R01-B-012
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 is a C-metal (C-Fe) bond, a chemical group associated with explosive properties, present in the molecule, but the classification is not possible due to no data.
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 *
-
-
- - No data available. Besides, there is information that it is combustible (ICSC (2004)).
8 Self-reactive substances and mixtures *
-
-
- - It contains a C-metal (C-Fe) bond, a chemical group associated with explosive properties, and an unsaturated bond, a chemical group associated with self-reactive properties, in the molecule, but the classification is not possible due to no data.
9 Pyrophoric liquids *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
10 Pyrophoric solids *
-
-
- - It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from an autoignition temperature of > 150 deg C (GESTIS (Access on May 2019)).
11 Self-heating substances and mixtures *
-
-
- - No data available.
12 Substances and mixtures which, in contact with water, emit flammable gases *
-
-
- - It contains a metal (Fe) in the molecule, but it was classified as "Not classified" because it is estimated that it does not react vigorously with water from the observation result that it is insoluble (ICSC (2004)).
13 Oxidizing liquids *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
14 Oxidizing solids *
-
-
- - Organic compounds containing no oxygen, fluorine or chlorine. It was classified as "Not classified (Not applicable)."
15 Organic peroxides *
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule. 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 *
-
-
- - It was classified as "Not classified" because it is not desensitized by wetting, dilution, etc.

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: 1,320 mg/kg (PATTY (6th, 2012), HSDB (Access on May 2019))
1 Acute toxicity (Dermal) *
-
-
- - [Rationale for the Classification]
Based on (1), it was classified as "Not classified."

[Evidence Data]
(1) LD50 for rats: > 3,000 mg/kg (REACH registration dossier (Access on July 2019))
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]
Classification not possible due to lack of data.
2 Skin corrosion/irritation *
-
-
- - [Rationale for the Classification]
Based on (1), it was classified as "Not classified." Besides, the category was changed since new data was obtained.

[Evidence Data]
(1) It was reported that in a skin irritation test according to OECD TG 404, the mean scores were 0.56 for erythema and 0 for edema, and the primary dermal irritation index (PII) was 0.5 (REACH registration dossier (Access on June 2019)).

[Reference Data, etc.]
(2) This substance may cause eye, skin, and respiratory tract irritation (PATTY (6th, 2012)).
3 Serious eye damage/eye irritation Category 2B
-
Warning
H320 P305+P351+P338
P337+P313
P264
[Rationale for the Classification]
Based on (1), it was classified in Category 2B.

[Evidence Data]
(1) In an eye irritation test according to OECD TG 405, slight irritation in the conjunctiva was observed, but all this disappeared after 7 days. It was reported that the mean scores for corneal opacity, iris, and conjunctiva at 24, 48, and 72 hours were 0, 0, and 2.5, respectively, whereas conjunctiva effects were resolved at 24 hours (REACH registration dossier (Access on June 2019)).

[Reference Data, etc.]
(2) This substance may cause eye, skin, and respiratory tract irritation (PATTY (6th, 2012), HSDB (Access on May 2019)).
4 Respiratory sensitization *
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Skin sensitization *
-
-
- - [Rationale for the Classification]
Based on (1), it was classified as "Not classified." Besides, the category was changed since new data was obtained.

[Evidence Data]
(1) In a skin sensitization test with guinea pigs according to OECD TG 406 (guinea pig maximisation test), no skin reaction was observed, and it was judged to be non sensitising (REACH registration dossier (Access on June 2019)).
5 Germ cell mutagenicity *
-
-
- - [Rationale for the Classification]
Based on (1) and (2), since it was all negative in standard combination tests including in vivo and in vitro, it corresponds to "Classification not possible" of the GHS classification guidance for the Japanese government. Therefore, it was classified as "Not classified." Since new data were available, the classification result was changed from the previous classification.

[Evidence Data]
(1) As for in vivo, it was negative in a micronucleus test with mice (REACH registration dossier (Access on July 2019)).
(2) As for in vitro, negative results were obtained in bacterial reverse mutation tests and a chromosomal aberration test with cultured mammalian cells (PATTY (6th, 2012), NTP DB (Access on May 2019)).
6 Carcinogenicity *
-
-
- - [Rationale for the Classification]
There were no data available for classification or carcinogenicity classifications by international organizations. Therefore, it was classified as "Classification not possible."

[Reference Data, etc.]
(1) In a test (animal species unknown) in which this substance was administered by intramuscular injection (total dose: 5,175 mg/kg) for 2 years, tumors were observed at the injection site (PATTY (6th, 2012)).
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
Based on (1), it was classified in Category 2. Besides, the classification result was changed from the previous classification since new information was added.

[Evidence Data]
(1) In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats dosed by gavage, clear effects on reproduction (decreased fertility, pre-implantation loss and post-implantation loss) were observed at the dose where parental toxicity (decreased body weight gain, decreased erythrocyte count, hemosiderin deposition, etc.) was observed (REACH registration dossier (Access on June 2019)).

[Reference Data, etc.]
(2) In a 6-month repeated dose toxicity test with dogs by gavage (capsule administration), testicular hypoplasia was observed at 100 and 300 mg/kg/day (ACGIH (7th, 2001), PATTY (6th, 2012)).
8 Specific target organ toxicity - Single exposure *
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data. Although (1) is described, there is no information on the original source, and no details could be confirmed. In the previous classification, it was classified in Category 3 (respiratory tract irritation) based on the same description in PATTY (5th, 2001), but it was judged to be insufficient as evidence for classification. The classification result was changed since there was no other information supporting respiratory tract irritation.

[Reference Data, etc.]
(1) This substance may cause eye, skin, and respiratory tract irritation (PATTY (6th, 2012), HSDB (Access on May 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 lesions were observed in the nasal cavity within the range of Category 1 by inhalation exposure of experimental animals, it was classified in Category 1 (respiratory organs). Besides, the dose conversion and target organs in the previous classification were reviewed and the classification result was changed.

[Evidence Data]
(1) When rats and mice were exposed to the vapour at 3-30 mg/m3 (converted guidance value: 0.002-0.02 mg/L, within the range of Category 1) by inhalation for 13 weeks (6 hours/day, 5 days/week), iron accumulation in the nose, larynx, trachea, lungs, and liver, and dose-dependent nasal lesions (necrosis, inflammation, metaplasia, and regeneration) were observed, and increased liver weight, etc. were observed at or above 10 mg/m3 (PATTY (6th, 2012)).
(2) When rats and mice were exposed to the vapour at 2.5-40 mg/m3 (converted guidance value: 0.0004-0.006 mg/L, within the range of Category 1) by inhalation for 2 weeks (6 hours/day), inflammation of the nasal turbinates and decreased body weight gain were observed (PATTY (6th, 2012)).
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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