GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 107-19-7
Chemical Name 2-Propyn-1-ol
Substance ID H30-B-005-MHLW, MOE
Classification year (FY) FY2018
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 FY2006  
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 Classification not possible
-
-
- - There is a chemical group associated with explosive properties (acetylenes) present in the molecule, but the classification is not possible due to no data.
2 Flammable gases (including chemically unstable gases) Not applicable
-
-
- - Liquid (GHS definition)
3 Aerosols Not applicable
-
-
- - Not aerosol products.
4 Oxidizing gases Not applicable
-
-
- - Liquid (GHS definition)
5 Gases under pressure Not applicable
-
-
- - Liquid (GHS definition)
6 Flammable liquids Category 3


Warning
H226 P303+P361+P353
P370+P378
P403+P235
P210
P233
P240
P241
P242
P243
P280
P501
A flash point is 33 deg C (closed cup) (ICSC (1997)).
7 Flammable solids Not applicable
-
-
- - Liquid (GHS definition)
8 Self-reactive substances and mixtures Classification not possible
-
-
- - There is a chemical group associated with explosive properties (acetylenes) present in the molecule, but the classification is not possible due to no data.
9 Pyrophoric liquids Not classified
-
-
- - It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 365 deg C (GESTIS (Accessed Jul. 2018)).
10 Pyrophoric solids 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 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
-
-
- - 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 applicable
-
-
- - Liquid (GHS definition)
15 Organic peroxides Not applicable
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule.
16 Corrosive to metals Classification not possible
-
-
- - No data available.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Category 3


Danger
H301 P301+P310
P264
P270
P321
P330
P405
P501
[Rationale for the Classification]
Based on (1)-(4), 2 cases correspond to Category 2-Category 3 and 6 cases to Category 3. Therefore, it was classified in Category 3 adopting the category with the larger number of cases. Since new information sources were used and the GHS classification guidance for the Japanese Government was revised from the previous classification, the category was changed.

[Evidence Data]
(1) LD50 values for rats: 93 mg/kg (male), 55 mg/kg (female) (PATTY (6th, 2012), NTP TR552 (2008), ACGIH (7th, 2001))
(2) LD50 values for rats: 110 mg/kg (male), 54 mg/kg (female) (PATTY (6th, 2012), NTP TR552 (2008))
(3) LD50 values for rats: 20-50 mg/kg, 56 mg/kg, 70 mg/kg (PATTY (6th, 2012))
(4) LD50 values for rats: 35-110 mg/kg (MAK/BAT (2005))
1 Acute toxicity (Dermal) Category 1


Danger
H310 P302+P352
P361+P364
P262
P264
P270
P280
P310
P321
P405
P501
[Rationale for the Classification]
Based on (1)-(3), one case corresponds to Category 1, one case to Category 1-Category 2 and one case to Category 2. Therefore, the category with the higher hazard was adopted, and it was classified in Category 1.

[Evidence Data]
(1) LD50 value for rabbits: 16 mg/kg (PATTY (6th, 2012), NTP TR552 (2008))
(2) LD50 value for rabbits: 88 mg/kg (PATTY (6th, 2012), NTP TR552 (2008))
(3) LD50 values for rabbits: 16-190 mg/kg (MAK/BAT (2005))
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - [Rationale for the Classification]
Liquid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Category 3


Danger
H331 P304+P340
P403+P233
P261
P271
P311
P321
P405
P501
[Rationale for the Classification]
Based on (1) and (2), it was classified in Category 3. Besides, the exposure concentration was lower than 90% of the saturated vapor concentration (15,198 ppm), so the reference values in units of ppm were applied as a vapor with little mist. The category was changed from the previous classification by use of the new information sources.

[Evidence Data]
(1) LC50 value (2 hours) for rats: 2,000 mg/m3 (872 ppm) (converted 4-hour equivalent value: 617 ppm) (MAK/BAT (2005))
(2) LC50 values (one hour) for rats: 1,040-1,200 ppm (converted 4-hour equivalent value: 520-600 ppm) (PATTY (6th, 2012), NTP TR552 (2008), ACGIH (7th, 2001))
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 1B


Danger
H314 P301+P330+P331
P303+P361+P353
P305+P351+P338
P304+P340
P260
P264
P280
P310
P321
P363
P405
P501
[Rationale for the Classification]
Based on (1) and (2), it was classified in Category 1B.

[Evidence Data]
(1) There are reports that in two skin irritation tests with rabbits, irritation and superficial necrosis after application of this substance itself and mild irritation after application of a 10% solution were observed (PATTY (6th, 2012), ACGIH (7th, 2001)).
(2) There is a report that in a skin irritation test (test method equivalent to OECD TG404) with rabbits, in the case of 1-minute application, slight necrosis was observed after 8 days and in the case of application for 5 or 15 minutes, severe necrosis was observed after 8 days (BUA 213 (1999), REACH registration dossier (Accessed Jul. 2018)).

[Reference Data, etc.]
(3) This substance was classified as "Skin Irrit. 1B" in EU CLP.
3 Serious eye damage/eye irritation Category 1


Danger
H318 P305+P351+P338
P280
P310
[Rationale for the Classification]
Although there are information (1) indicating eye damage and information (2) indicating irritation, by giving priority to the former, it was classified in Category 1.

[Evidence Data]
(1) There is a report that in an eye irritation test with rabbits, after application of the undiluted liquid of this substance, marked pain and irritation occurred, and corneal damage was irreversible (PATTY (6th, 2012)).

[Reference Data, etc.]
(2) There is a report that in an eye irritation test with rabbits, after application of a 10% solution of this substance, slight irritation occurred but this resolved within a few days (PATTY (6th, 2012)).
4 Respiratory sensitization Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Skin sensitization Classification not possible
-
-
- - [Rationale for the Classification]
Although information (1) indicating that this substance is not a skin sensitizer was obtained, the details of the test are unknown and adequate evidence to judge as "Not classified" is not obtained. Therefore, it was classified as "Classification not possible." Besides, by reviewing the weight of evidence, the category was changed from the previous classification.

[Reference Data, etc.]
(1) There is a report that as a result of skin sensitization test with guinea pigs, no skin sensitization was shown (ACGIH (7th, 2001), PATTY (6th, 2012)).
5 Germ cell mutagenicity Classification not possible
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was classified as "Classification not possible" in accordance with the GHS Classification Guidance for the Japanese Government. Besides, information sources different from the previous classification were added and reviewed, and the classification result was changed.

[Evidence Data]
(1) As for in vivo, negative (male) or equivocal (female) results were found in a micronucleus test with mouse peripheral blood by inhalation exposure (NTP TR552 (2008), PATTY (6th, 2012)), and a negative result was obtained in a micronucleus test with mouse bone marrow by oral administration (PATTY (6th, 2012), MAK/BAT (2005)).
(2) As for in vitro, negative or positive results in bacterial reverse mutation tests (NTP TR552 (2008), PATTY (6th, 2012)) and a positive result in a mammalian cell chromosome aberration test (PATTY (6th, 2012), MAK/BAT (2005)) were obtained.
6 Carcinogenicity Category 2


Warning
H351 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
As for carcinogenicity, there are no available reports on humans.
According to (1) and (2), since the tumors observed in two species of experimental animals were mostly benign tumors, it was classified in Category 2. Besides, the classification result was reviewed using new information sources, and the category was assigned.

[Evidence Data]
(1) In a carcinogenicity study in which rats were exposed by inhalation to the vapor of this substance for 2 years, in males in the high dose (64 ppm) group, nasal respiratory epithelial adenomas were observed in 3/50 animals, and the incidence is higher than the range in historical control data. In addition, an increased incidence of mononuclear leukemia is reported in males in the same group (NTP TR552 (2008), PATTY (6th, 2012)).
(2) In a carcinogenicity study in which mice were exposed by inhalation to the vapor of this substance for 2 years, the incidence of nasal respiratory epithelial adenomas tended to increase in both sexes, and a significant increase was observed in the high dose (32 ppm) group (NTP TR552 (2008), PATTY (6th, 2012)). In addition, an increased incidence of Harderian gland adenoma was observed in males in the high dose (NTP TR552 (2008)).
(3) The NTP concluded that there is some evidence of carcinogenicity of this substance in male rats and male and female mice (NTP TR552 (2008)).
(4) There are no classification results by domestic and international organizations.
7 Reproductive toxicity Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
8 Specific target organ toxicity - Single exposure Category 3 (Respiratory tract irritation)


Warning
H335 P304+P340
P403+P233
P261
P271
P312
P405
P501
[Rationale for the Classification]
Based on (1), it was classified in Category 3 (respiratory tract irritation). Besides, information sources different from the previous classification were added and reviewed, and the classification result was changed since the target organ is considered to be the respiratory tract.

[Evidence Data]
(1) There is a description that this substance is irritating to the respiratory tract (NTP TR552 (2008), PATTY (6th, 2012)).
9 Specific target organ toxicity - Repeated exposure Category 1 (respiratory organs, liver, kidney)


Danger
H372 P260
P264
P270
P314
P501
[Rationale for the Classification]
Based on (1)-(5), the liver and the kidney are considered as target organs through the oral and inhalation routes, and through the inhalation route, the respiratory organs are also considered as target organs in (3)-(5), and all effects were found within the dose range of Category 1. Therefore, it was classified in Category 1 (respiratory organs, liver, kidney). Besides, information sources different from the previous classification were added and reviewed, and the respiratory organs were added as a target organ.

[Evidence Data]
(1) In a study with rats dosed by gavage for 28 days, at or above 45 mg/kg/day (converted guidance value: 15 mg/kg/day, within the range of Category 2), hepatocyte damage (hypertrophy, vacuolation, etc. of the nucleus), increases in GPT, alkaline phosphatase, glutamate dehydrogenase activity, and inhibition of cholinesterase activity were observed (Environmental Risk Assessment for Chemical Substances Vol.6, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008)).
(2) In a study with rats dosed by gavage for 13 weeks, at 15 mg/kg/day (within the range of Category 2), effects on the liver (increased liver weight, hepatocellular vacuolization, bile duct proliferation, megalocytosis) and effects on the kidney (increased kidney weight, karyomegaly of renal tubular epithelial cells) were observed (Environmental Risk Assessment for Chemical Substances Vol.6, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008), PATTY (6th, 2012), IRIS (1990)).
(3) As for the inhalation route, in a study in which rats were exposed by inhalation to the vapor of this substance over 3 months (7 hours/day, 5 days/week, 59 days of administration), at 80 ppm (converted guidance value: 0.14 mg/L, within the range of Category 1), in the liver and the kidney, degenerative changes were observed in addition to increased weight (ACGIH (7th, 2001), PATTY (6th, 2012)).
(4) In studies in which rats or mice were exposed by inhalation to the vapor of this substance for 14 weeks (6 hours/day, 5 days/week), at 16-64 ppm (converted guidance value: 0.03-0.12 mg/L, within the range of Category 1), in the nasal cavity of rats, hyperplasia and squamous metaplasia of the respiratory epithelium and necrosis of the olfactory epithelium were observed. In addition, in mice, suppurative inflammation in the nasal cavity, squamous metaplasia and hyaline degeneration of the respiratory epithelium, atrophy, necrosis, and glandular tissue hyperplasia of the olfactory epithelium, and atrophy of the nasal turbinate were observed (NTP TR552(2008), PATTY (6th, 2012)).
(5) In studies with rats and mice exposed by inhalation for 2 years, in both species, similar changes as in the 13-week inhalation exposure tests were observed in the respiratory epithelium and olfactory epithelium of the nasal cavity at concentrations at or above 16 ppm in rats and at or above 8 ppm in mice (converted guidance value: 0.015-0.03 mg/L, within the range of Category 1) (NTP TR552 (2008), PATTY (6th, 2012)).
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 (Acute) Category 2
-
-
H401 P273
P501
It was classified in Category 2 from 96-hour LC50 = 1.44 mg/L for fish (Pimephales promelas) (NLM HSDB: 2018, EPA AQUIRE: 2018, Geiger, D. L. et al. (1988)).
11 Hazardous to the aquatic environment (Long-term) Not classified
-
-
- - Chronic toxicity data were not obtained. It was classified as "Not classified" due to rapid degradability (readily biodegradable, an average degradation rate by BOD: 95% (J-CHECK, 2001)), and no bioaccumulation (LogKow: -0.38 (PHYSPROP Database: 2018)).
12 Hazardous to the ozone layer Classification not possible
-
-
- - No data available.


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.

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