GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 103-95-7
Chemical Name 3-p-cumenyl-2-methylpropionaldehyde
Substance ID R02-A-006-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 Category 4
-
Warning
H227 P370+P378
P210
P280
P403
P501
A flash point was 79.5 deg C (closed-cup) (GESTIS (Accessed June 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 240 deg C (ECHA (Accessed June 2020)).
10 Pyrophoric solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
11 Self-heating substances and mixtures Classification not possible
-
-
- - 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" (Category 5 in UN GHS classification) from (1).

[Evidence Data]
(1) LD50 for rats: 3,810 mg/kg (JECFA (2004), REACH registration dossier (Accessed May 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: > 5,000 mg/kg (REACH registration dossier (Accessed May 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 Category 2


Warning
H315 P302+P352
P332+P313
P362+P364
P264
P280
P321
[Rationale for the Classification]
It was classified in Category 2 from (1), (2).

[Evidence Data]
(1) It is reported that in a skin irritation test with rabbits (n = 3) (semi-occlusive, 4-hour application, 7-day observation), skin irritation was observed (erythema/eschar score: 2.7/2/2, edema score: 3/3/2.7) (REACH registration dossier (Accessed May 2020)).
(2) It is reported that in a skin irritation test with rabbits (n = 4) (semi-occlusive, 4-hour application, 7-day observation), skin irritation was seen (erythema/eschar score: 2/2/2/2.7, edema score: 2.7/2.7/2.3/3) (REACH registration dossier (Accessed May 2020)).

[Reference Data, etc.]
(3) It is reported that in a skin irritation test with rabbits (n = 4) (semi-occlusive, 4-hour application, 7-day observation), skin irritation was found (erythema/eschar score: 2/2/2/2, edema score: 2.3/2.7/2/1.7) (REACH registration dossier (Accessed May 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 = 6) (7-day observation), no eye irritation was seen (corneal opacity score: 0/0.7/0.3/0/0.7/0, iritis score: 0.3/0.3/0/0.3/0.3/0.3, conjunctival redness score: 1.3/1/1.3/0.3/0.7/1, chemosis score: 0/0.3/0/0/0.7/0) (REACH registration dossier (Accessed May 2020)).
4 Respiratory sensitization Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Skin sensitization Category 1B


Warning
H317 P302+P352
P333+P313
P362+P364
P261
P272
P280
P321
P501
[Rationale for the Classification]
It was classified in Category 1B from (1).

[Evidence Data]
(1) It is reported that in a local lymph node assay (LLNA) with mice (n = 4) (OECD TG 429), irritation index (SI values) was 1 (0%), 1.4 (1%), 1.34 (2.5%), 1.84 (10%), 3.26 (25%), 5.16 (50%), the EC3 value was calculated as 22.3%, and it was weakly senstizing (REACH registration dossier (Accessed May 2020)).
5 Germ cell mutagenicity Classification not possible
-
-
- - [Rationale for the Classification]
Since there was no in vivo data available, classification was not possible due to lack of data.

[Evidence Data]
(1) In an in vitro mammalian cell (CHL) chromosome aberration test, negative results were reported (JECDB (Accessed May 2020)).
(2) In a bacterial reverse mutation test (OECD TG471 & EU Method B. 13/14, GLP), negative results were reported (REACH registration dossier (Accessed May 2020)).
6 Carcinogenicity Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
7 Reproductive toxicity Category 1B


Danger
H360 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
In (1), at the dose at which general toxicity appeared in parental animals, significant male infertility due to effects on the testes or sperms in parental male rats and increased incidences of the eye lesions in pups were observed. Since reproduction toxicity effects were observed at the dose at which general toxicity appeared in parental rats, it was classified as Category 1B with consideration given to the significance of the effects.

[Evidence Data]
(1) It was reported that in a one-generation reproduction toxicity study with rats dosed by gavage (OECD TG415, GLP, beginning 83 days prior to cohabitation, through cohabitation, continuing through the day before sacrifice (males), beginning 14 days before cohabitation, through cohabitation and gestation, to day 22 postpartum (females)), at 150 mg/kg/day, reduced body weight gains, an increase in liver weight, and findings on the adrenal glands were observed in parental animals, no occurrence of pregnancy following mating between treated male rats and untreated female rats (pregnancy occurred: 1 of 24 cases), masses on the cauda epididymis (sperm granulomas), an increase in epididymal weight, reduced sperm motility from sperm taken from the vas deferens (all rats) (due to the presence of drifting debris, headless sperm, detached heads, and/or less than the required number of sperm for evaluation), an increased number of litters having pups with a lenticular opacity (20 of 24 litters), lenticular opacities (first observed on day 16 and persisted until day 22 postpartum), an increased number of male and female rats with a lenticular opacity during the postweaning period, and a significant reduction in the anogenital distance of male pups at weaning were observed (REACH registration dossier (Accessed May 2020)).
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.

[Evidence Data]
(1) It was reported that in a 14-day oral administration test with rabbits dosed by gavage, at 300 mg/kg/day (converted guidance value: 46.7 mg/kg/day, within the range for Category 2), no changes in body weight, food consumption, clinical findings, and the weight of any reproductive or non-reproductive organs were observed. Also, it was reported that there were no histopathological findings in the testes or epididymis and no changes in sperm parameters (REACH registration dossier (Accessed May 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 2
-
-
H401 P273
P501
It was classified in Category 2 from 48-hour EC50 = 1.4 mg/L for crustacea (Daphnia magna) (REACH registration dossier, 2021).
11 Hazardous to the aquatic environment Long term (Chronic) Category 2


-
H411 P273
P391
P501
It was classified in Category 2 because it is not rapidly degradable (BIOWIN) and due to 21-day NOEC = 0.71 mg/L for crustacea (Daphnia magna) (REACH registration dossier, 2021).
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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