GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 78-83-1 |
| Chemical Name | Isobutyl alcohol |
| Substance ID | H29-B-071 |
| Classification year (FY) | FY2017 |
| 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 |
| 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 3 |
 Warning |
H226 |
P303+P361+P353
P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501 |
Based on a flash point of 28 deg C (closed cup), and a boiling point of 108 deg C (ICSC (J) (2005)), it was classified in Category 3. Besides, it is classified in Class 3, PGIII in UNRTDG (UN 1212). |
| 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 415 deg C (ICSC (J) (2005)). |
| 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. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Not classified |
- |
- | - | Based on reported LD50 values for rats of 2,460 mg/kg (OEL Documentations (Japan Society For Occupational Health (JSOH),1987), EHC 65 (1987), SIDS (2005), PATTY (6th, 2012)), 2,650 mg/kg, 2,740 mg/kg (SIDS (2005)), 3,100 mg/kg (EHC 65 (1987), SIDS (2005), PATTY (6th, 2012)), and 3,350 mg/kg (SIDS (2005)), it was classified as "Not classified" (Category 5 in UN GHS classification). The category was changed from the previous classification according to the GHS Classification Guidance for the Japanese Government. |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | Based on a reported LD50 value for rabbits of 2,460 mg/kg (females) (SIDS (2005)), 3,400 mg/kg (SIDS (2005), PATTY (6th, 2012)), 4,240 mg/kg (EHC 65 (1987), SIDS (2005)), it was classified as "Not classified" (Category 5 in UN GHS classification). The category was changed from the previous classification based on the GHS classification guidance for the Japanese government. |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Category 4 |
 Warning |
H332 |
P304+P340
P261 P271 P312 |
Based on reported LC50 values of 6,336 ppm (19.2 mg/L) (EHC 65 (1987), SIDS (2005)), and 8,000 ppm (OEL Documentations (Japan Society For Occupational Health (JSOH), 1987)) in a 4-hour inhalation exposure test with rats, it was classified in Category 4. It was classified in Category 5 in the previous classification, but as a result of reconfirming the data, the category was changed. Besides, since the LC50 values were lower than 90% of the saturated vapor pressure concentration (11,881 ppm), a reference value in the unit of ppm was applied as vapour with little mist. |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 2 | Skin corrosion/irritation | Category 2 |
Warning |
H315 |
P302+P352
P332+P313 P362+P364 P264 P280 P321 |
Based on a description that in a skin irritation test (compliant with OECD TG 404) with rabbits, erythema and edema occurred in all of 6 animals to which this substance was applied, and slight irritation symptoms remained in 4 even at 14 days after application (SIDS (2005)), and a description that slight erythema occurred after an application to human skin (OEL Documentations (Japan Society For Occupational Health (JSOH), 1987), ACGIH (7th, 2001), PATTY (6th, 2012)), it was classified in Category 2. Besides, this substance was classified as "Skin Irrit. 2, H315" in EU CLP classification (ECHA CL Inventory (Access on June 2017)). |
| 3 | Serious eye damage/eye irritation | Category 1 |
 Danger |
H318 |
P305+P351+P338
P280 P310 |
There is no case in which the liquid was applied to humans, but there is a report that 8 factory workers who were engaged in producing a coating agent containing this substance and butyl acetate developed visual deficits due to vacuolization of the corneal epithelium after severe conjunctival irritations (PATTY (6th, 2012), DFGOT Vol. 19 (2003), OEL Documentations (Japan Society For Occupational Health (JSOH), 1987), Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013)), and a description that in an eye irritation test (compliant with OECD TG 405) with rabbits, slight to moderate corneal injury, iritis, severe conjunctival irritation occurred, and slight conjunctival redness was observed even 21 days after application (SIDS (2005)), therefore, it was classified in Category 1. Besides, this substance was classified as "Eye Dam. 1, H318" in EU CLP classification (ECHA CL Inventory (Access on June 2017)). The information including new one was revised, and the category was changed. |
| 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 |
- |
- | - | The substance was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese Government. As for in vivo, a micronucleus test with mice was negative (SIDS (2005), PATTY (6th, 2012)), and a micronucleus test with rat bone marrow cells was negative (Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013)). As for in vitro, bacterial reverse mutation tests, a gene mutation test, a mouse lymphoma assay, a micronucleus test, and a chromosomal aberration test with mammalian cultured cells were all negative (SIDS (2005), DFGOT Vol. 19 (2003), JECFA FAS 40 (1998), PATTY (6th, 2012), Environmental Risk Assessment for Chemical Substances Vol. 11 (Ministry of the Environment, 2013)). |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | In a 2-year carcinogenicity test with rats or mice dosed by drinking water, no increase of tumor incidence was observed in either sex in rats and mice, and it was concluded that there was no carcinogenicity (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, Access on June 2017)). Other than that, there is no data available for classification. From the above, since it was negative in 2 species of experimental animals, it corresponds to "Not classified" in the oral route, but there is no data on the inhalation route, therefore, it was classified as "Classification not possible" due to lack of data. |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - |
In a 2-generation study with rats by the inhalation route, at doses up to 2,500 ppm (7,580 mg/m3), both general toxic effects and reproductive toxic effects on parental animals and effects on pups were not observed (SIDS (2005), Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013), PATTY (6th, 2012)). In addition, in developmental toxicity studies with pregnant rats or rabbits exposed by inhalation during the organogenesis period, no developmental effect was observed either in rats or in rabbits at up to 3,030 ppm (10,000 mg/m3) where decreased body weight gain was observed in maternal rabbits (SIDS (2005), Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013), PATTY (6th, 2012), DFGOT Vol. 19 (2003)). From the above, as for the inhalation route, all of the results of the 2-generation study with rats and the developmental toxicity studies with rats or rabbits were negative, and they are considered to correspond to "Not classified," but there is no toxicity information in an oral route, therefore, it was classified as "Classification not possible" due to lack of data for this hazard class. Besides, the classification result was changed from the previous classification ("Not classified"). |
| 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 |
There is no information on a single-exposure to this substance in humans. As for experimental animals, there is a report that in a 6-hour single inhalation exposure study with rats, at or above 9.09 mg/L (converted 4-hour equivalent value: 11.13 mg/L, corresponding to the range of Category 2), hypoactivity and decreased response to the startle reflex were observed (SIDS (2005)). In addition, there is a report that in a test in which rats were exposed by inhalation to the saturated vapor of this substance for 6 hours, hypoactivity, lacrimation, coma, prostration, short breaths, and shallow breaths were observed, but there was no death case (SIDS Dossier (2005)). The precise exposure concentration was not measured in this study, but the concentration converted to a 4-hour exposure from 11,881 ppm (36 mg/L) of the saturated vapor concentration was calculated to be 44 mg/L, which exceeds the range for Category 2. In addition, there is a report that in a 4-hour single inhalation exposure studies with rats and rabbits, at 15.7 mg/L within the range of Category 2, respiratory tract irritation was observed, and central nervous system depression was observed after 3 days (EHC 65 (1987), DFGOT Vol. 19 (2003)). From the above, it was classified in Category 3 (respiratory tract irritation, narcotic effects). Besides, the report in the previous classification that pharyngeal irritation was observed by exposure to this substance in humans (EHC 65 (1987), PATTY (4th, 1994), Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), 1993)) was not adopted because of the exposure to not only this substance but also butyl acetate. |
| 9 | Specific target organ toxicity - Repeated exposure | Classification not possible |
- |
- | - |
As for humans, there is a report that among seven workers who had handled and had been exposed to this substance and 1-butanol for half a month to 2 years in a photographic laboratory without ventilation, two workers felt discomfort, two workers complained of transient vertigo, and three workers complained of nausea, tinnitus, headaches, nystagmus, and visual deficits in addition to severe vertigo (Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013), PATTY (6th, 2012)). As for experimental animals, there are reports including those from 13-week toxicity studies with rats or mice dosed by drinking water (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, Access on June 2017)), a 92-93-day repeated oral dose toxicity study with rats, and a 3-month inhalation toxicity study with rats (Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, Vol.11, 2013), PATTY (6th, 2012), SIDS (2005)). Also, no effect was observed within the guidance range for the Category 2 in any of the studies. From the above, as for effects observed in humans, which were not by exposure only to this substance and could be transient acute effects, they could not be taken as evidence for classification, but since there is a possibility of effects on the nervous system, the substance was classified not as "Not classified" but as "Classification not possible." Since new information sources were used, the classification result was different from the previous classification. |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Besides, it was classified in Category 2 in the previous classification due to the description that this substance is classified in Category 2 for the aspiration hazard in the UN report. It is described in ICSC of the UN report, which is an information source in List 3, that "If this liquid is swallowed, aspiration into the lungs may result in chemical pneumonitis" (ICSC (2005)), but the original source could not be confirmed, and it is considered to be a description as a general precaution, therefore, it could not be adopted as the evidence for classification. Other than these, the evidence data in the previous classification (Category 2) could not be confirmed. In addition, according to Japanese Industrial Standards for classification of chemicals based on GHS (JIS Z7252:2014) which was revised after the previous classification, a substance is allocated to only Category 1 for this hazard class (not allocated to Category 2). |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (Acute) | Not classified |
- |
- | - | From 96-hour LC50 = 949 mg/L for crustacea (Orconectes immunis), 96-hour LC50 = 1,330 mg/L for fish (Oncorhynchus mykiss), and 48-hour EC50 (rate method) = 2,300 mg/L for algae (Desmodesmus subspicatus) (all Environmental Risk Assessment for Chemical Substances vol. 11 (Ministry of the Environment, 2013)), it was classified as "Not classified." |
| 11 | Hazardous to the aquatic environment (Long-term) | Not classified |
- |
- | - | Due to being rapidly degradable (readily biodegradable, a degradation rate by BOD: 90% (J-CHECK, 1976)), no bioaccumulation (LogKow: 0.76 (SRC PhysProp Database: 2017)), 21-day NOEC (reproduction inhibition) = 4.0 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances vol. 11 (Ministry of the Environment, 2013), ECETOC TR91: 2003), and 48-hour EC10 (rate method) = 900 mg/L for algae (Desmodesmus subspicatus) (Environmental Risk Assessment for Chemical Substances vol. 11 (Ministry of the Environment, 2013)), it was classified as "Not classified." |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
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* 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. |