Latest GHS Classification Results by the Japanese Government (edited by NITE)

Japanese



GENERAL INFORMATION
 
Item Information
CAS RN 599-64-4
Chemical Name 4-(2-Phenylpropan-2-yl)phenol
Substance ID m-nite-599-64-4_v1
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) To Guidance List
UN GHS document (External link) To UN GHS document
FAQ(GHS classification results by the Japanese Government) To FAQ
List of Information Sources (Excel file) List of Information Sources
List of Definitions/Abbreviations Definitions/Abbreviations
Sample Label by MHLW (External link) To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link) To Workplace Safety Site (MHLW)
OECD/eChemPortal (External link) To OECD/eChemPortal (External link)

PHYSICAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification Classification year (FY) GHS Classification Guidance for the Japanese Government
1 Explosives Not classified (Not applicable)
-
-
- - There are no chemical groups associated with explosive properties present in the molecule. FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
2 Flammable gases Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
3 Aerosols Not classified (Not applicable)
-
-
- - Not aerosol products. FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
4 Oxidizing gases Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
5 Gases under pressure Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
6 Flammable liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
7 Flammable solids Classification not possible
-
-
- - No data available. FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
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. FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
9 Pyrophoric liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
10 Pyrophoric solids Classification not possible
-
-
- - No data available. FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
11 Self-heating substances and mixtures Classification not possible
-
-
- - Test methods applicable to solid (melting point <= 140 deg C) substances are not available. FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
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). FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
13 Oxidizing liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
14 Oxidizing solids Not classified (Not applicable)
-
-
- - The substance is an organic compound containing oxygen which is chemically bonded only to carbon or hydrogen. FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
15 Organic peroxides Not classified (Not applicable)
-
-
- - Organic compounds containing no bivalent -O-O- structure. FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
16 Corrosive to metals Classification not possible
-
-
- - Test methods applicable to solid substances are not available. FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
17 Desensitized explosives -
-
-
- - - - -

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification Classification year (FY) GHS Classification Guidance for the Japanese Government
1 Acute toxicity (Oral) Category 4


Warning
H302 P301+P312
P264
P270
P330
P501
There are two LD50 values for rats of > 2,000 mg/kg [OECD TG 401, GLP] (JECDB (Access on Dec. 2012)) and 1,770 mg/kg [FDA guideline, GLP] (USEPA/HPV (2002)), one of them corresponds to "Not classified," and the other corresponds to Category 4. It was classified in Category 4 by adopting a more hazardous category. FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
1 Acute toxicity (Dermal) Classification not possible
-
-
- - No data available. FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
1 Acute toxicity (Inhalation: Gases) Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - No data available. FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - No data available. FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
2 Skin corrosion/irritation Classification not possible
-
-
- - No data available. FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
3 Serious eye damage/eye irritation Classification not possible
-
-
- - No data available. FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
4 Respiratory sensitization Classification not possible
-
-
- - No data available. FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
4 Skin sensitization Classification not possible
-
-
- - No data available. FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
5 Germ cell mutagenicity Classification not possible
-
-
- - The classification is not possible due to no in vivo test data. Besides, as for in vitro, it is reported that it was negative in an Ames test (JECDB (2000), USEPA/HPV (2002)), negative in a chromosomal aberration test with CHL/lU cells (JECDB (2000)), positive in a chromosomal aberration test with CHO cells (HPVIS (2009)), and negative in a mouse lymphoma test (HPVIS (2009)). FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
6 Carcinogenicity Classification not possible
-
-
- - No data available. FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501
In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test by oral administration to rats (OECD TG 422, GLP), both male and female parent animals (F0) showed decreased weight gain before mating or during mating at or above 50 mg/kg/day, while a statistically significant decrease in the number of total implantations/litter was observed in the high dose group (300 mg/kg/day) (HPVIS (2005)). Therefore, it was classified in Category 2. Besides, no effects on the numbers of pups or live pups per litter were found in any dose group, and there was no evidence of toxicity in F1 offspring. FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- - In an acute oral toxicity test with rats (FDA guideline, GLP), red stains on the muzzle, piloerection, slight depression, brown-yellow stains on the urogenital area, rapid breathing, unkempt fur, etc. were observed at 625 or 1,250 mg/kg, and at 2,500 and 5,000 mg/kg, saliva-like stains on the muzzle and hunched posture were seen in addition to the above signs, and all the animals died (USEPA/HPV (2002)). It is reported that in another single administration test by oral administration to rats (OECD TG 401, GLP), diarrhea and reduced weight gain were found after the administration of 1,500 or 2,000 mg/kg, but there were no deaths, and no serious toxic signs were observed at 14-day observation after the administration (JECDB (Access on Dec. 2012)). It was hard to specify the target organ within the range of the above data, and effects are unknown at the limit value of the guidance values (2,000 mg/kg). Therefore, it was classified as "Classification not possible." FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
9 Specific target organ toxicity - Repeated exposure Category 2 (kidney)


Warning
H373 P260
P314
P501
It is reported that in a 28-day repeated oral administration toxicity test with rats (doses: 0, 100, 300, 1,000 mg/kg/day), granular casts, etc. in the kidney were observed in both males and females in the 1,000 mg/kg group (converted guidance value: 311 mg/kg) above the guidance value range, and an increase in drinking water and an increase in regeneration in the tubular epithelium (males), which were estimated to be related to kidney disorders, were found in the 300 mg/kg group (converted guidance value: 93.3 mg/kg) (JECDB (Access on Dec. 2012)). And in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test by oral administration to rats (OECD TG 422, GLP), dose-related lesions in the kidney were described as histopathological findings in the 300 mg/kg/day group (converted guidance value: 93.3 mg/kg/day) in males (HPVIS (2005)). Because the doses of the above findings correspond to the guidance values for Category 2, it was classified in Category 2 (kidney). Besides, findings in the liver were not adopted because they were just weight changes, not accompanied by histological changes at doses within the guidance value range. FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
10 Aspiration hazard Classification not possible
-
-
- - No data available. FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)

ENVIRONMENTAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification Classification year (FY) GHS Classification Guidance for the Japanese Government
11 Hazardous to the aquatic environment Short term (Acute) Category 2
-
-
H401 P273
P501
It was classified in Category 2 from 96-hour LC50 = 1.2 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2004)). FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
11 Hazardous to the aquatic environment Long term (Chronic) 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 (not readily degradable, a degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2002)), and 72-hour NOEC = 0.33 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 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 (not readily degradable, a degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2002)), and 96-hour LC50 = 1.2 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2004)).
From the above results, it was classified in Category 2.
FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)
12 Hazardous to the ozone layer Classification not possible
-
-
- - This substance is not listed in the Annexes to the Montreal Protocol. FY2012 GHS Classification Guidance by the Japanese Government (July, 2010)


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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