GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 123-86-4
Chemical Name Butyl acetate
Substance ID H26-B-118, R-068
Classification year (FY) FY2014
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 FY2009   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)
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
-
-
- - 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 2


Danger
H225 P303+P361+P353
P370+P378
P403+P235
P210
P233
P240
P241
P242
P243
P280
P501
It was classified in Category 2 based on a flash point of 22 deg C (closed cup) and a boiling point of 126 deg C (ICSC (2003)).
Besides, it is classified in Class 3, PG II (UN1123) in UNRTDG.
7 Flammable solids Not applicable
-
-
- - Liquid (GHS definition)
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 classified
-
-
- - It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 420 deg C (ICSC (2003)).
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 Not classified
-
-
- - Steel and aluminum can be used as a container (Hommel (1991)).

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 reports of LD50 values of 3,200-14,130 mg/kg (SIDS (2009)), 10,700-14,130 mg/kg (DFGOT vol. 19 (2003)), 12,760 mg/kg (male), 10,736 mg/kg (female) (SIDS (2009)), 13,100 mg/kg (male), 11,000 mg/kg (female) (CICAD 64 (2005)), and 14,130 mg/kg (CICAD 64 (2005), Environmental Risk Assessment for Chemical Substances Vol.1 (Ministry of the Environment, 2002), ACGIH (7th, 2001)) for rats, it was classified as "Not classified."
1 Acute toxicity (Dermal) Not classified
-
-
- - Based on reports of LD50 values of > 5,000 mg/kg (ACGIH (7th, 2001)), > 5,000-17,600 mg/kg (SIDS (2009)), > 14,080 mg/kg (male, female) (SIDS (2009)), and > 20 mL/kg (=17,600 mg/kg) (DFGOT vol. 19 (2003), ACGIH (7th, 2001)) for rabbits, it was classified as "Not classified."
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Liquid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - There were 4 reports of LC50 values (4 hours) of 2,000 ppm (ACGIH (7th, 2001)), > 4,000 ppm (DFGOT vol. 19 (2003)), > 32,000 mg/m3 (=6,752 ppm) (CICAD 64 (2005)) and of an LC50 value (6 hours) of > 8,000 ppm (male, female) (converted 4-hour equivalent value: 9,798 ppm) for rats (SIDS (2009)). Among these, one value corresponded to Category 3, but the category could not be identified from the other 3 values, therefore, it was classified as "Classification not possible." New information sources (SIDS (2009), CICAD 64 (2005), DFGOT vol.19 (2003)) were added, and the category was revised.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - There were 7 reports of LC50 values (4 hours) of 0.74 mg/L (OECD TG 403) (SIDS (2009)), 0.74 mg/L, 1.8 mg/L, 5.1 mg/L, > 45 mg/L (CICAD 64 (2005)), 1.86 mg/L (DFGOT vol.19 (2003), ACGIH (7th, 2001)) and > 23.4 mg/L (OECD TG 403) (SIDS (2009)) for rats. Since there was large variability even among OECD TG 403 compliant data, it was classified as "Classification not possible."
2 Skin corrosion/irritation Not classified
-
-
- - There are reports that after application of this substance (99.6%) to rabbits for 4 hours, no irritative reaction was observed and scores of eschar formation and edema were both 0 (SIDS (2009)), and that no irritation was observed in a test with guinea pigs (SIDS (2009)). In addition, there is a report that it was not irritating in a patch test by 48-hour occlusive application of 4% of this substance to volunteers (SIDS (2009)). From the above results, it was classified as "Not classified" (Category 3 in UN GHS classification).
3 Serious eye damage/eye irritation Category 2B
-
Warning
H320 P305+P351+P338
P337+P313
P264
There is a report that after application of 0.1 mL of this substance to the eyes of rabbits, slight to moderate iritis was observed but this disappeared after 48 hours (SIDS (2009)), and there were multiple results with mild irritation or no irritation in other eye irritation tests with rabbits (SIDS (2009)). In addition, there is a report that very slight irritation was observed in volunteers exposed to this substance (70-1400 mg/m3) (SIDS (2009)). From the above results, it was classified in Category 2B.
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, although there are reports that no sensitization was observed in a test with guinea pigs or in an ear swelling test with mice (SIDS (2009)), and there is a description no sensitization was observed in humans (Environmental Risk Assessment for Chemical Substances Vol.1 (Ministry of the Environment, 2002)), since details of the test methods and results were unknown, the data were judged to be inadequate for classification.
5 Germ cell mutagenicity Classification not possible
-
-
- - Classification not possible due to lack of data. There are no in vivo data. As for in vitro, it was negative in bacterial reverse mutation tests and a chromosomal aberration test with cultured mammalian cells (SIDS (2009), ACGIH (7th, 2001), DFGOT vol. 19 (2003), NTP DB (Access on October 2014), HSDB (Access on September 2014)).
6 Carcinogenicity Classification not possible
-
-
- - Classification not possible due to lack of data.
7 Reproductive toxicity Classification not possible
-
-
- - Classification not possible due to lack of data.
Although in a teratogenicity test with rats by the inhalation route, at doses where maternal toxicity (decreased body weight) was observed, reduced fetal growth and abnormal formation of the ribs (wavy, fused, branched) were found, and in a teratogenicity test with rabbits by the inhalation route, without maternal toxicities, increased incidences of misaligned sternebrae and retinal folds, and morphological variations of the gall bladders were observed in fetuses, these were considered not malformations but variations, and no adverse effects were observed in development including teratogenicity (SIDS (2009), CICAD 64 (2005), DFGOT vol. 19 (2003), ACGIH (2001)).
In a test in which female rats were exposed by inhalation for 3 weeks before mating, then mated with untreated male animals, and subsequently exposed by inhalation until Day 16 of gestation, although maternal toxicities (decreased food consumption, decreased body weight, decreased absolute liver weight, increased relative kidney and lung weights) were observed, there were no effects on fertility, and delayed fetal growth was observed for the fetuses (CICAD 64 (2005), DFGOT vol. 19 (2003), Environmental Risk Assessment for Chemical Substances Vol.1 (Ministry of the Environment, 2002), ACGIH (2001)).
Since in these studies, teratogenicity was not observed, and delayed fetal growth and variations of the fetuses were only slight effects, it was not adopted as evidence of the classification according to the GHS Classification Guidance for the Japanese Government.
From the above, no effects on the developmental toxicity and fertility in female animals were observed. However, since the information on the fertility in male animals was not sufficient, it was classified as "Classification not possible."
8 Specific target organ toxicity - Single exposure Category 3 (respiratory tract irritation, narcotic effects)


Warning
H335
H336
P304+P340
P403+P233
P261
P271
P312
P405
P501
This substance was irritating to the respiratory tract (OEL Documentations (Japan Society For Occupational Health (JSOH), 1994), Environmental Risk Assessment for Chemical Substances Vol.1 (Ministry of the Environment, 2002), ACGIH (7th, 2001), CICAD 64 (2005), DFGOT vol. 19 (2003)).
In humans, headache and nausea by inhalation exposure of the vapour, and dizziness, dyspnea, unconsciousness and weakness at high concentrations were reported (OEL Documentations (Japan Society For Occupational Health (JSOH), 1994), ACGIH (7th, 2001), CICAD 64 (2005), DFGOT vol. 19 (2003)).
As for experimental animals, ataxia, forced respiration and narcotic effects by an inhalation exposure of rats at 1.3 mg/L, dyspnea as well as these symptoms by an inhalation exposure of rats at 32.6 mg/L were observed (CICAD 64 (2005), ACGIH (7th, 2001), SIDS (2009)). Symptoms such as coordination ataxia reported in an inhalation exposure of rats were considered to be due to narcotic effects of this substance.
From the above, this substance was judged to have respiratory tract irritation and narcotic effects, and it was classified in Category 3 (respiratory tract irritation, narcotic effects).
Besides, the following items were not adopted in the findings described in the previous classification. That is, the case of combined exposure in humans was not adopted due to the possibility of effects caused by other substances. The findings of "In an aerosol inhalation test with rats, pulmonary congestion, alveolar hemorrhage, sloughing of the bronchiolar mucosa, necrosis of the alveolar epithelial cells and pulmonary edema, etc. were observed at 540 ppm/4 hours (2.57 mg/4 hours) (ACGIH (7th, 2001))" were not adopted due to the data being on dead animals.
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - As for experimental animals, in a study in which rats were exposed by inhalation to this substance (presumed to be the vapour) for 13 weeks, only effects on the respiratory organs (nasal irritation symptoms, necrosis of the olfactory epithelium) were observed at high concentrations corresponding to "Not classified" (1,500 ppm or above: 7.05 mg/L/6 hours) (SIDS (2009), CICAD 64 (2005), DFGOT vol. 19 (2003)). In addition, there is a description that also in a test in which guinea pigs were exposed by inhalation to this substance for 28 days, no effects were observed in a hematological test (blood counts), urine examinations and pathological examination (necropsy) at 4,840 mg/m3 (converted guidance value: 1.00 mg/L/6 hours) (Environmental Risk Assessment for Chemical Substances Vol.1 (Ministry of the Environment, 2002), CICAD 64 (2005)). However, there was no toxicity information through other routes and findings in humans, therefore, it was classified as "Classification not possible" due to lack of data.
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 3
-
-
H402 P273
P501
It was classified in Category 3 from 96-hour LC50 = 18 mg/L for fish (Pimephales promelas) (CICAD 64, 2005, SIDS, 2009).
11 Hazardous to the aquatic environment (Long-term) Not classified
-
-
- - If chronic toxicity data are used, then it is classified as "Not classified" due to rapid degradability (a degradation rate by BOD: 98% (SIDS, 2009)), and 72-hour EC10 = 296 mg/L for algae (Desmodesmus subspicatus) (CICAD 64, 2005).
If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" due to rapid degradability (a degradation rate by BOD: 98% (SIDS, 2009)), a low bioaccumulation estimate (LogKow = 1.78 (PHYSPROP Database, 2009)) despite 96-hour LC50 = 18 mg/L for fish (Pimephales promelas) (CICAD 64, 2005, SIDS, 2009).
From the above results, it was classified as "Not classified."
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.

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