GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 57018-52-7
Chemical Name 1-tert-Butoxy-2-propanol
Substance ID R02-B-029-MHLW, MOE
Classification year (FY) FY2020
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised Revised
Classification result in other fiscal year FY2011  
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) 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 classified (Not applicable)
-
-
- - There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."
2 Flammable gases Not classified (Not applicable)
-
-
- - Liquid (GHS definition). It was classified as "Not classified."
3 Aerosols Not classified (Not applicable)
-
-
- - Not aerosol products. It was classified as "Not classified."
4 Oxidizing gases Not classified (Not applicable)
-
-
- - Liquid (GHS definition). It was classified as "Not classified."
5 Gases under pressure Not classified (Not applicable)
-
-
- - Liquid (GHS definition). It was classified as "Not classified."
6 Flammable liquids Category 3


Warning
H226 P303+P361+P353
P370+P378
P403+P235
P210
P233
P240
P241
P242
P243
P280
P501
It was classified in Category 3 based on a flash point of 45 deg C (closed cup) (GESTIS (Access on April 2020)).
7 Flammable solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition). It was classified as "Not classified."
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. It was classified as "Not classified."
9 Pyrophoric liquids Not classified
-
-
- - It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from an autoignition temperature of 373 deg C (ICSC (2006)).
10 Pyrophoric solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition). It was classified as "Not classified."
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). It was classified as "Not classified."
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. It was classified as "Not classified."
14 Oxidizing solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition). It was classified as "Not classified."
15 Organic peroxides Not classified (Not applicable)
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified."
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. It was classified as "Not classified."

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: 3,771 mg/kg (Patty (6th, 2012), NTP TR515 (2004), IARC 88 (2006))
(2) LD50 for rats: 4,599 mg/kg (ECETOC TR95 vol.ll (2005))
1 Acute toxicity (Dermal) Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) There was no death case in a test in which rabbits were applied at 2,000 mg/kg for 24 hours (Patty (6th, 2012), NTP TR515 (2004), IARC 88 (2006)).
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. There is information in (1), but because the category cannot be determined with the data alone, it was classified as "Classification not possible." Besides, because the exposure concentration was lower than 90% of the saturated vapor pressure concentration (6,185 ppm), the reference value in the unit of ppm was applied as a vapor with little mist.

[Reference Data, etc.]
(1) LC50 for rats (4 hours): > 500 ppm (Patty (6th, 2012), NTP TR515 (2004), IARC 88 (2006))
(2) Vapor pressure of this substance: 4.7 mmHg (20 deg C) (HSDB (Access on April 2020)) (converted value for the saturated vapor pressure concentration: 6,185 ppm)
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), (2).

[Evidence Data]
(1) In a skin irritation test by 24-hour occlusive application of this substance to rabbits (application amount 2 g/kg), desquamation, erythema, fissures, discoloration, etc. were seen. And in another similar test, slight erythema and desquamation were observed over 7 days, and the primary irritation index (PII) was reported to be 0.6 (NTP TR515 (2004), Patty (6th, 2012), GESTIS (Access on April 2020), HSDB (Access on April 2020)).

[Reference Data, etc.]
(2) This substance was a moderate irritant in a skin irritation test by 24-hour occlusive application to rabbits (ECETOC TR 95 vol.II (2005)).
3 Serious eye damage/eye irritation Category 2A


Warning
H319 P305+P351+P338
P337+P313
P264
P280
[Rationale for the Classification]
It was classified in Category 2A from (1).

[Evidence Data]
(1) In an eye irritation test with rabbits on this substance, reversible corneal opacity, transient conjunctival redness, chemosis, and discharge were observed, and it was judged as a severe eye irritant (NTP TR515 (2004), ECETOC TR 95 vol.II (2005), Patty (6th, 2012), GESTIS (Access on April 2020), HSDB (Access on April 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), (2).

[Evidence Data]
(1) It was negative in a skin sensitization test with guinea pigs according to OECD TG 406 (GESTIS (Access on April 2020), Patty (6th, 2012)).
(2) No sensitization was observed in a skin sensitization test with guinea pigs (maximization test) (ECETOC TR 95 vol.II (2005)).
5 Germ cell mutagenicity Not classified
-
-
- - [Rationale for the Classification]
From (1), (2), it was classified as "Not classified" based on expert judgment.

[Evidence Data]
(1) As for in vivo, it was reported to be weakly positive in a micronucleus test with the peripheral blood after 3-month inhalation exposure of mice (IARC 119 (2019), IARC 88 (2006), NTP TR515 (2004)). The positive result in the test was very weak, which was not found in males (IARC 88 (2006)).
(2) As for in vitro, it was reported to be negative and positive (weakly positive in TA97) in bacterial reverse mutation tests, negative in a chromosomal aberration test and a sister chromatid exchange test with cultured mammalian cells (IARC 119 (2019), IARC 88 (2006), NTP TR515 (2004)), and negative in a chromosomal aberration test with human peripheral blood lymphocytes and a gene mutation test with L5178Y mouse lymphoma (ECETOC TR 95 vol.II (2005)).
6 Carcinogenicity Category 2


Warning
H351 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
It was classified in Category 2 from (1), (2).

[Evidence Data]
(1) As for classification results by domestic and international organizations, it was classified in Group 2B by IARC (IARC 119 (2019)) and Group 2B by the Japan Society for Occupational Health (JSOH) (Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), proposed in 2018)).
(2) In carcinogenicity tests by 104-week inhalation exposure to this substance of male and female rats and mice, based on marginally increased incidences of renal tubule and liver neoplasms found in male rats, it was concluded that there was equivocal evidence of carcinogenicity in male rats. There was no evidence of carcinogenicity in female rats. And in mice, significant increases in the incidences of liver neoplasms were observed in both males and females, and it was concluded that there was clear evidence of the carcinogenicity of this substance in male and female mice (NTP TR 515 (2004)).
7 Reproductive toxicity Not classified
-
-
- - [Rationale for the Classification]
Based on (1) to (3), it was classified as "Not classified."

[Evidence Data]
(1) In a one-generation reproduction toxicity study with orally dosed rats, at doses at which salivation was observed after the administration as an effect on dams, a slightly lower birth body weight and a slight decrease in survival rate on postnatal day 4 were observed in offspring, but neither of these differences was significant (ECETOC TR 95 vol. II (2005)).
(2) In an inhalation exposure test with female rats on days 6-15 of gestation, no effect on fetuses was observed at doses at which maternal toxicity (pallor, an increase in liver weight) were observed (IARC 88 (2006), ECETOC TR 95 vol. II (2005)).
(3) In an inhalation exposure test with female rabbits on days 7-19 of gestation, no maternal toxicity or fetal toxicity was observed (IARC 88 (2006), ECETOC TR 95 vol. II (2005)).
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]
There was no report on single exposure to this substance in humans. Based on the results of (1) obtained in the experimental animals, it was classified in Category 3 (narcotic effects).

[Evidence Data]
(1) In an oral toxicity test by administration of this substance to rats, at or above 2,239 mg/kg (within the range exceeding Category 2), lethargy, ataxia, prostration, and irregular breathing were observed (NTP TR515 (2004), Patty (6th, 2012)).

[Reference Data, etc.]
(2) It was reported that in an inhalation exposure test by administration of this substance to rats, at 2.68 mg/L (within the range for Category 1), hepatic extra-medullary hematopoiesis was observed, but since no further details were available, it was not used as the rationale for the classification (NTP TR515 (2004)).
(3) It was reported that in a dermal exposure test by administration of this substance to rabbits, at 2,000 mg/kg (within the range for Category 2), no adverse effects were observed during the 14-day observation period after the exposure (NTP TR515 (2004)).
9 Specific target organ toxicity - Repeated exposure Category 2 (respiratory organs, liver, kidney)


Warning
H373 P260
P314
P501
[Rationale for the Classification]
There was no report on repeated exposure to this substance in humans. Based on (1) and (2), in experimental animals, at doses for Category 2, the effects on the respiratory organs, liver, and kidney were observed. Therefore, it was classified in Category 2 (respiratory organs, liver, kidney). After a review of the information, the classification result was changed from the previous classification.

[Evidence Data]
(1) In a 104-week inhalation exposure test with mice (exposed to vapors for 6 hours/day, 5 days/week), at 600 ppm (converted guidance value 2.52 mg/L equivalent, within the range exceeding Category 2), centrilobular hypertrophy of hepatocytes of the liver was observed; and at 1,200 ppm (converted guidance value 5.05 mg/L equivalent, within the range exceeding Category 2), squamous metaplasia of the respiratory epithelium of the nasal cavity was observed (NTP TR515 (2004)).
(2) In a 104-week inhalation exposure test with rats (exposed to vapors for 6 hours/day, 5 days/week), at 75 ppm (0.406 mg/L equivalent, within the range for Category 2), hyaline degeneration of the olfactory epithelium was observed, and furthermore, basophilic foci of the liver and chronic nephropathy were observed in males. In rats, alpha 2mu-globulin nephropathy peculiar to males was known, but since the finding of chronic nephropathy was also observed in females at or above 1,200 ppm (6.49 mg/L equivalent, within the range exceeding Category 2), it was suggested that it was not related to alpha 2mu-globulin nephropathy (NTP TR515 (2004)).
10 Aspiration hazard Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data. Besides, from (1), kinematic viscosity was calculated as 3.8 mm2/sec at 25 deg C, and kinematic viscosity was not more than 14 mm2/s at 40 deg C, but no other information could be obtained.

[Reference Data, etc.]
(1) Kinematic viscosity was 3.8 mm2/s at 25 deg C (calculated from viscosity at 25 deg C: 3.3 mPa*s (HSDB (Access on April 2020)) and density of 0.872 g/cm3 (HSDB (Access on April 2020))).

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) Classification not possible
-
-
- - No data available.
11 Hazardous to the aquatic environment Long term (Chronic) Classification not possible
-
-
- - No data available.
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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