GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 98-29-3
Chemical Name 4-tert-Butylcatechol
Substance ID H28-A-006, C-017A
Classification year (FY) FY2016
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 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) 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 solids 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 Classification not possible
-
-
- -  No data available.
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
-
-
- -  It is a substance with a melting point of 55 deg C or lower, but the classification is not possible due to no data.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Not classified
-
-
- -  Based on the LD50 value of 2,820 mg/kg for rats (NTP TOX-70 (2002)), the substance was classified as "Not classified" (Category 5 in UN GHS classification).
1 Acute toxicity (Dermal) Category 3


Danger
H311 P302+P352
P361+P364
P280
P312
P321
P405
P501
 Based on the LD50 value of 630 mg/kg for rabbits (NTP TOX-70 (2002)), the substance was classified in Category 3.
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
-
-
- -  Classification not possible due to lack of data.
2 Skin corrosion/irritation Classification not possible
-
-
- -  Classification not possible due to lack of data.
 Besides, although the details of the test were unknown, it is described that severe skin irritation was observed in a skin irritation test (24 hours) using rabbits, and it is also described that skin irritation was observed in humans (NTP TOX-70 (2002)).
3 Serious eye damage/eye irritation Classification not possible
-
-
- -  Classification not possible due to lack of data.
 Besides, although the details of the test were unknown, it is described that severe eye irritation was observed in an eye irritation test using rabbits and that it is an eye irritant in humans (NTP TOX-70 (2002)).
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.
5 Germ cell mutagenicity Classification not possible
-
-
- -  As for in vivo, micronucleus tests using bone marrow cells of rats or mice were negative, and as for in vitro, a bacterial reverse mutation test was negative (NTP DB (Access on June 2016)). Therefore, the substance was classified as "Classification not possible" in accordance with the GHS classification guidance for the Japanese government.
6 Carcinogenicity Category 2


Warning
H351 P308+P313
P201
P202
P280
P405
P501
 In a two-year carcinogenicity studies using rats and mice dosed by feeding, tumor (squamous cell papilloma) was observed in the forestomach of high dose groups of male and female rats and male mice (rats: 4,000 ppm, mice: 5,000 ppm) (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare) (Access on May 2016)). Moreover, it is reported that in a test in which rats were administered an initiator (MNNG) as single dose by gavage followed by administration of this substance for a year at 15,000 ppm by feeding, papilloma and carcinoma were observed in forestomach, indicating this substance has promoting activity (NTP TOX-70 (2002)).
 From the above, based on the fact that the site of tumor formation observed in two species of experimental animals are in the forestomach which does not exist in human and as it was a benign tumor, it was judged that the classification in Category 2 is appropriate for this substance.
 Besides, this substance corresponds to a substance subject to the guidelines in order to prevent the impairment of workers' health based on the Industrial Safety and Health Law Article 28, Paragraph 3.
7 Reproductive toxicity Classification not possible
-
-
- -  Classification not possible due to lack of data.
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- -  Classification not possible due to lack of data.
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- -  No data available for humans.
 As for experimental animals, two 14-week repeated dose toxicity studies using rats dosed by feeding were performed. In one study, hyperkeratosis of the forestomach epithelium was observed in the group of 781 ppm (males and females: 70 mg/kg/day) in a range of Category 2 (NTP TOX-70 (2002)). In the other study, hyperplasia of the forestomach epithelium was observed at 1,600 ppm (males: 93 mg/kg/day, females: 107 mg/kg/day) in a range of Category 2 (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, Access on May 2016).
 From the absence of ulceration and inflammation in the forestomach, it was judged that the hyperkeratosis and hyperplasia were not caused by irritation (NTP TOX-70 (2002)).
 As above, the effect on the forestomach was observed in a range of Category 2. However, the substance was classified as "Classification not possible" because the forestomach does not exist in human.
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) Classification not possible
-
-
- -  No data available.
11 Hazardous to the aquatic environment (Long-term) Classification not possible
-
-
- -  No data available.
12 Hazardous to the ozone layer Classification not possible
-
-
- -  No data available.


NOTE:
* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted.
* Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement.
Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file.
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government,
and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.
* Codes assigned to each of the hazard statements and codes for each of the precautionary statement are
based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations.

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