GHS Classification Result

日本語で表示



GENERAL INFORMATION
Item Information
CAS RN 6386-38-5
Chemical Name Methyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate
Substance ID 25A0038
Classification year (FY) FY2013
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)/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 by the Japanese Government (July, 2013)
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 applicable
-
-
- - There are no chemical groups associated with explosive properties present in the molecule.
2 Flammable gases (including chemically unstable gases) Not applicable
-
-
- - Solid (GHS definition)
3 Aerosols Not applicable
-
-
- - Not aerosol products.
4 Oxidizing gases Not applicable
-
-
- - Solid (GHS definition)
5 Gases under pressure Not applicable
-
-
- - Solid (GHS definition)
6 Flammable liquids Not applicable
-
-
- - Solid (GHS definition)
7 Flammable solid Classification not possible
-
-
- - No data available.
8 Self-reactive substances and mixtures Not applicable
-
-
- - There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9 Pyrophoric liquids 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 182 deg C (IUCLID (2000)).
11 Self-heating substances and mixtures Classification not possible
-
-
- - Test methods applicable to solid (melting point <= 140 deg C) substances are not available.
12 Substances and mixtures which, in contact with water, emit flammable gases 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 applicable
-
-
- - Solid (GHS definition)
14 Oxidizing solids 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 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.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Not classified
-
-
- - It was classified as "Not classified" based on a report on an LD50 value of > 5,000 mg/kg for rats (SIDS (2004)).
1 Acute toxicity (Dermal) Not classified
-
-
- - It was classified as "Not classified" based on a report on an LD50 value of > 3,000 mg/kg for rabbits (SIDS (2004)).
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Not applicable
-
-
- - Solid (GHS definition)
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - There is a report on an LC50 value (4 hours) of > 0.0555 mg/L for rats, but it is described that because the particle size was above 10 micrometers for more than 99.5% of the particle used, there was no substantial systemic uptake (SIDS (2004)). Therefore, the classification is not possible.
2 Skin corrosion/irritation Not classified
-
-
- - It was classified as "Not classified" (Category 3 in UN GHS classification) because multiple reports are stating that no irritation was observed in a test with rabbits (SIDS (2004), IUCLID (2000)).
3 Serious eye damage/eye irritation Not classified
-
-
- - In SIDS (2004), there are reports on the results of two tests, which resulted in slight irritation or no irritation. Therefore, it was classified as "Not classified."
4 Respiratory sensitization Classification not possible
-
-
- - Classification not possible due to lack of data.
4 Skin sensitization Classification not possible
-
-
- - Classification not possible due to lack of data. Besides, it is described in SIDS (2004) that in an experiment in human volunteers, there was nobody who showed sensitization to a 0.5% solution, but the details are unknown.
5 Germ cell mutagenicity Classification not possible
-
-
- - Classification not possible due to lack of data. There are no in vivo data, and as for in vitro, it was negative in a bacterial reverse mutation test (SIDS (2004)).
6 Carcinogenicity Classification not possible
-
-
- - Classification not possible due to lack of data.
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501
In a reproduction/developmental toxicity screening test (OECD TG 421) with rats in the oral route, reproductive toxicity (decreased litter size, decreased pup weights, decreased pup viability on day 4) was observed at the dose where parental toxicity (decreased body weights and food consumption, increased liver weights, hypertrophy of the hepatocytes, cholangiofibrosis) was found (SIDS (2004)). Sufficient information on developmental toxicity including malformations was not obtained. Therefore, it was classified in Category 2.
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- - Classification not possible due to lack of data. Besides, after oral administration to rats, slight to moderate dyspnea, ruffled fur, and slight exophthalmos were observed at the dose (5,000 mg/kg) above the guidance value range, but these disappeared within 10 days (SIDS (2004)), and in the dermal route, no clear adverse effects were found at the dose (3,000 mg/kg) within the guidance value range (SIDS (2004)). Therefore, it corresponds to "Not classified" in the oral and dermal routes. On the other hand, it is reported that for rats in the inhalation route, no toxicity symptoms were observed at the dose within the guidance value for Category 1 (SIDS (2004)), but there is no information on adverse effects at the dose above the guidance value for Category 2. Therefore, it was classified as "Classification not possible" due to lack of data.
9 Specific target organ toxicity - Repeated exposure Category 2 (liver, thyroid)


Warning
H373 P260
P314
P501
In a 28-day diet administration test with rats, enlargement and histological changes in the liver (homogeneous cytoplasm containing eosinophilic droplets, abnormalities of the nucleus (nuclei varying in size, binucleated cells)) were observed at the dose (68.4 mg/kg/day (converted guidance value)) within the guidance value range for Category 2 (SIDS (2004)). Furthermore, in a 90-day diet administration test with rats, activated appearance in the thyroid (resembling a thyroid of rats given TSH (thyroid-stimulating hormone)) was observed from the dose (70 mg/kg/day) within the guidance value range for Category 2, and findings in the liver similar to those in 28-day administration were found at the high dose (140 mg/kg/day) corresponding to "Not classified" (SIDS (2004)). From the above, it was classified in Category 2 (liver, thyroid).
10 Aspiration hazard Classification not possible
-
-
- - 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 (Acute) Category 2
-
-
H401 P273
P501
From 72-hour EC50 = 2.3 mg/L for algae (Desmodesmus subspicatus) (SIDS, 2004), it was classified in Category 2.
11 Hazardous to the aquatic environment (Long-term) Category 2


-
H411 P273
P391
P501
If chronic toxicity data are used, then it is classified in Category 2 due to being not rapidly degradable (BIOWIN), and NOEC = 0.123 mg/L for crustacea (Daphnia magna) (SIDS, 2004).
If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 2 due to being not rapidly degradable (BIOWIN), and 72-hour EC50 = 2.3 mg/L for algae (Desmodesmus subspicatus) (SIDS, 2004).
From the above results, it was classified in Category 2.
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.

To GHS Information