GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 103-60-6
Chemical Name 2-Phenoxyethyl isobutyrate
Substance ID R02-A-061-METI, MOE
Classification year (FY) FY2020
Ministry who conducted the classification Ministry of Economy, Trade and Industry (METI)/Ministry of the Environment (MOE)
New/Revised New
Classification result in other fiscal year  
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)  
Model SDS by MHLW (External link)  
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)
-
-
- - Liquid (GHS definition)
3 Aerosols Not classified (Not applicable)
-
-
- - Not aerosol products.
4 Oxidizing gases Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
5 Gases under pressure Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
6 Flammable liquids Not classified
-
-
- - A flash point was 137 deg C (Closed cup) (GESTIS (Accessed Sep. 2020)).
7 Flammable solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
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
-
-
- - It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 504 deg C (ECHA (Accessed Sep. 2020)).
10 Pyrophoric solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
11 Self-heating substances and mixtures Classification not possible
-
-
- - Classification is not possible because test methods applicable to liquid substances are not available.
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)
-
-
- - The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
14 Oxidizing solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
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
-
-
- - No data 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) Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) LD50 for rats: > 5,000 mg/kg (GESTIS (Accessed Oct. 2020))

1 Acute toxicity (Dermal) Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) LD50 for rats: > 2,000 mg/kg (OECD TG402, GLP) (REACH registration dossier (Accessed Oct. 2020))

1 Acute toxicity (Inhalation: Gases) Not classified
-
-
- - [Rationale for the Classification]
Liquid (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) Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.

2 Skin corrosion/irritation Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) It is reported that in a skin irritation test with rabbits (n = 8) (equivalent to OECD TG 404, semi-occlusive, 4-hour application, 72-hour observation), slight erythema in 2 animals and slight erythema and edema in 2 were observed after 24 hours, and slight erythema in 1 and slight erythema and edema in 2 persisted after 72 hours (erythema/eschar score: 0/1/0.3/0/0/0/1/1, edema score: 0/0/0/0/0/0/1/1.3) (REACH registration dossier (Accessed Oct. 2020)).
3 Serious eye damage/eye irritation Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) It is reported that in an eye irritation test with rabbits (n = 2) (OECD TG 405, GLP, 72-hour observation), conjunctival irritation was observed in both the animals after 1 hour, but one recovered within 24 hours, and the other recovered within 48 hours (corneal opacity score: 0/0, iritis score: 0/0, conjunctival redness score: 0.3/0, chemosis score: 0/0) (REACH registration dossier (Accessed Oct. 2020)).
4 Respiratory sensitization Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Skin sensitization Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) It is reported that in a local lymph node assay (LLNA) with mice (n = 4/group) (OECD TG 429, GLP), stimulation index (SI values) was 1.0 (0.1%), 1.2 (1%), 1.1 (10%), 1.6 (100%) (REACH registration dossier (Accessed Oct. 2020)).
5 Germ cell mutagenicity Not classified
-
-
- - [Rationale for the Classification]
Based on (1) to (3), it was classified as "Not classified."

[Evidence Data]
(1) In a micronucleus test using the bone marrow from mice, negative results were reported (REACH registration dossier (Accessed Sep. 2020), EFSA (2007)).
(2) In a bacterial reverse mutation test, negative results were reported (REACH registration dossier (Accessed Sep. 2020), EFSA (2007)).
(3) In a gene mutation test using the mouse lymphoma cells, negative results were reported (REACH registration dossier (Accessed Sep. 2020)).
6 Carcinogenicity Classification not possible
-
-
- - [Rationale for the Classification]
Classification was not possible due to lack of data.
7 Reproductive toxicity Classification not possible
-
-
- - [Rationale for the Classification]
Classification was not possible due to lack of data.
8 Specific target organ toxicity - Single exposure Category 3 (Narcotic effects)


Warning
H336 P304+P340
P403+P233
P261
P271
P312
P405
P501
[Rationale for the Classification]
Based on (1), it was classified in Category 3 (narcotic effects).

[Evidence Data]
(1) It was reported that in an acute oral toxicity test with mice dosed by gavage, lethargy, signs of stress, labored breathing, and hypothermia were observed at 2,060 mg/kg (in the range corresponding to "Not classified") and semicoma was observed at 5,150 mg/kg (in the range corresponding to "Not classified") (REACH registration dossier (Accessed Oct. 2020)).

[Reference Data, etc.]
(2) It was reported that in an acute dermal toxicity test with rats (OECD TG 402, GLP), no effect was observed at 2,000 mg/kg (upper limit of Category 2) (REACH registration dossier (Accessed Oct. 2020)).
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - [Rationale for the Classification]
Based on (1), it was classified as "Not classified" in the dermal route. However, classification was not possible due to lack of data since there was not sufficient information available for classification in other routes.

[Evidence Data]
(1) It was reported that in a 90-day subchronic dermal toxicity study by occlusive dermal application on rats (OECD TG 411, GLP, 6 hours/day), at 1,000 mg/kg/day (in the range corresponding to "Not classified"), a very mild epidermal thickening (partially with hyperkeratosis) in the skin was observed in all animals with the exception of one female in the control group, but beyond that, no systemic effect was observed (REACH registration dossier (Accessed Oct. 2020)).
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) Category 3
-
-
H402 P273
P501
It was classified in Category 3 from 96-hour LC50 = 13.3 mg/L for fish (Danio rerio) (REACH registration dossier, 2021).
11 Hazardous to the aquatic environment Long term (Chronic) Category 3
-
-
H412 P273
P501
Sufficient data on rapid degradability were not obtained.
If chronic toxicity data are used, then it is classified as "Not classified" from 72-hour NOErC = 1.6 mg/L for algae (Raphidocelis subcapitata) (REACH registration dossier, 2021).
If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 3 from 96-hour LC50 = 13.3 mg/L for fish (Danio rerio) (REACH registration dossier, 2021).
By drawing a comparison between the above results, it was classified in Category 3.
12 Hazardous to the ozone layer Classification not possible
-
-
- - This substance is not listed in the Annexes to the Montreal Protocol.


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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