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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	78-84-2
Chemical Name	Isobutyraldehyde
Substance ID	H30-B-006-METI, MOE
Classification year (FY)	FY2018
Ministry who conducted the classification	Ministry of Economy, Trade and Industry (METI)/Ministry of the Environment (MOE)
New/Revised	Revised
Classification result in other fiscal year	FY2008
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	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 -24 deg C (closed cup) and a boiling point of 63-64 deg C (ICSC (J) (2015)). Besides, it is classified in Class 3, PG II (UN2045) 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 165 deg C (ICSC (J) (2015)).
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 4	Warning	H302	P301+P312 P264 P270 P330 P501	[Rationale for the Classification] Based on (1)-(3), as a result of adopting the category with the highest hazard, it was classified in Category 4. [Evidence Data] (1) LD50 for rats: 3,730 mg/kg (male) (SIDS (2004)) (2) LD50 for rats: 1,600-3,700 mg/kg (SIDS (2004)) (3) LD50 for rats: 960 mg/kg (NTP TR472 (1999), Environmental Risk Assessment for Chemical Substances Vol.8, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2010)).
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) LD50 for rabbits: ca.7.1 mL/kg (ca. 5,630 mg/kg) (SIDS (2004)) (2) LD50 for guinea pigs: > 20,000 mg/kg (SIDS (2004))
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	[Rationale for the Classification] Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1)-(3), it was classified as "Not classified." Besides, the test concentrations shown in (1)-(3) were less than 90% of the saturated vapor concentration (223,800 ppm), and then the reference value of a vapour was applied as a vapour without mist. [Evidence Data] (1) LC50 for rats: 62.6 mg/L (converted value based on 60,000 ppm of LC50 in a 30-minute inhalation test with rats) (NTP TR472 (1999)) (2) LC50 for mice: 28.9 mg/L (converted value based on 13,860 ppm of LC50 in a 2-hour inhalation test with mise) (NTP TR472 (1999)) (3) LC50 for rats (4 hours): between 8,000 ppm (23.6 mg/L) and 16,000 ppm (47.2 mg/L) (death cases: 1/6 at 8,000 ppm, 6/6 at 16,000 ppm) (SIDS (2004))
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] Based on (1) and (2), it was classified as "Not classified." Besides, because (3)-(5) are data in 1952, and the test details are unknown, and (6) is information from ICSC, these were not adopted for classification. [Evidence Data] (1) There is a report that in a skin irritation test with rabbits (OECD TG404, GLP, n=3), after 4-hour semi-occlusive application of this substance itself (purity 99% or more), erythema (score: 0.7-1.7) and edema (score: 0-0.3) were observed with recovery within 7 days (REACH registration dossier (Accessed Oct. 2018)). (2) There is a report that in a skin irritation test with rabbits (OECD TG404, GLP, n=4), in which this substance itself (purity 98%) was applied by using a patch for 4 hours, PII was is 0.13 in 72 hours (ECETOC TR66 (1995)). [Reference Data, etc.] (3) There is a report that in a skin irritation test with rabbits (n=6), after open application of this substance, significant erythema was observed in one animal (SIDS (2004)). (4) There is a description that this substance causes moderate to severe skin irritation and burns in rabbits (SIDS (2004)). (5) There is a description that this substance may be corrosive at extremely high concentrations (SIDS (2004)). (6) There is a description that this substance is corrosive to the skin, and that it causes pain, redness, blisters, and burns upon contact with the skin (Environmental Risk Assessment for Chemical Substances Vol.8, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2010)).
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2B. Besides, although there is information ((3)-(5)) which indicates that this substance is corrosive, it was classified based on highly reliable information for which test details can be confirmed. By using new information sources, the category was changed from the previous classification. [Evidence Data] (1) There is a report that in an eye irritation test with rabbits (OECD TG405, GLP, n=3), in which this substance itself (purity 99% or more) was applied, the conjunctiva score of 2.3 and the conjunctival edema score of 2 were obtained with recovery within 7 days (REACH registration dossier (Accessed Oct. 2018)). (2) There is a report that in an eye irritation test with rabbits (n =1), in which one drop of this substance itself (purity 95%) was applied, the corneal opacity score of 1, the conjunctiva score of 2 and the conjunctival edema score of 2 were obtained with recovery within 7 days (REACH registration dossier (Accessed Oct. 2018)). [Reference Data, etc.] (3) There is a report that, in which undiluted liquid of this substance was applied to rabbit eyes, moderate corneal irritation at 0.005 mL and severe corneal damage at 0.02 mL occurred (SIDS (2004)). (4) There is information that this substance causes severe eye irritation to rabbit eyes, and it may be corrosive at extremely high concentrations (SIDS (2004)). (5) There is information that this substance is corrosive to the eyes, and that it causes pain, redness, severe burns, and loss of vision if it enters into the eyes (Environmental Risk Assessment for Chemical Substances Vol.8, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2010)).
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] There is a GLP data of (1) but no other data. Therefore, it was classified as "Classification not possible" due to lack of data. [Evidence Data] (1) There is a report that in an auricle swelling test with mice (GLP, n = 8/dose), in which each 3-30% solution of this substance (acetone: olive oil (4:1)) was applied, no sign of skin sensitization was observed with or without adjuvant (SIDS (2004), NTP TR472 (1999), REACH registration dossier (Accessed Oct. 2018)).
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] As for in vivo, there were cases among which (1) showed positive results under cytotoxicity, and (2) showed positive results near the lethal dose, but this substance was concluded to be negative. As for in vitro, it was negative in a bacterial reverse mutation test in (3) and was positive in (4) and (5). Based on the weight of evidence (WoE), because it was judged that the knowledge of classification in Category 2 was not agreed us on it was classified as "Classification not possible." Besides, because it was judged that (1) was not valid, the category was changed from the previous category based on WoE. [Evidence Data] (1) As for in vivo, in a chromosomal aberration test with mouse bone marrow, it was impossible to evaluate at the highest dose of 2,000 mg/kg due to animal death, but it was positive by a single intraperitoneal dose of 1,750 mg/kg (SIDS (2004)). (2) In in-vivo micronucleus tests with the bone marrow of mice and rats, it was negative in a 3 day intraperitoneal administration at maximum 1,250 mg/kg (SIDS (2004)). (3) As for in vitro, in bacterial reverse mutation tests, it was positive in Escherichia coli (without metabolic activation), but multiple negative results were obtained in Salmonella (SIDS (2004)). (4) An in vitro gene mutation test with mouse lymphoma was positive under a cytotoxic concentration (SIDS (2004)). (5) In a sister chromatid exchange test and a chromosomal aberration test with cultured mammalian cells (CHO) gave positive results (SIDS (2004)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] There is no available report on humans for carcinogenicity. Since animal test results are limited to (1), classification was not possible due to lack of data. [Evidence Data] (1) In a carcinogenicity test with rats and mice exposed by inhalation (500-2,000 ppm, 2 years), no increase in tumor incidence related to exposure was observed (NTP TR472 (1999)). (2) There are no classification results by domestic and international organizations.
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] Though the possibility of developmental effects by exposure to pregnant rats is considered to be low based on (1), there are no reproductive test data. Therefore, classification was not possible due to lack of data. [Reference Data, etc.] (1) In a developmental toxicity test with pregnant rats exposed by inhalation (1,000 to 4,000 ppm) to this substance during the organogenesis period (gestational Day 6-15), decreased body weight gain and nasal mucosa lesions were observed in maternal animals by administration of 2,500 ppm or more at which, however, no developmental effects were observed in the fetuses (SIDS (2004), Environmental Risk Assessment for Chemical Substances Vol.8, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2010)).
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 the data from (1) and (2), it was classified in Category 3 (respiratory tract irritation). [Evidence Data] (1) There are descriptions that inhalation of this substance may cause sore throat, cough, burning sensation, shortness of breath, and hardness of breathing, and that inhalation may cause pulmonary edema (Environmental Risk Assessment for Chemical Substances Vol.8, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2010)). (2) In the case of a single inhalation exposure of two strains of mice to the vapor of this substance, each RD50, the concentration at which their respiratory rate decreased to 50% of that in the control group was 3,016 ppm for B6C3F1 and 4,167 ppm for Swiss-Webster (SIDS (2004)).
9	Specific target organ toxicity - Repeated exposure	Category 2 (respiratory organs)	Warning	H373	P260 P314 P501	[Rationale for the Classification] Based on (1) and (2), in the inhalation route, histological changes were observed in the nasal cavity due to stimulation within the dose range of Category 2. Moreover, based on long-term test data of (3) and (4), the effect by stimulation to the nasal cavity was also observed, but no adverse effects were observed on organs other than the respiratory organs in any tests through the inhalation route. In the oral route, based on data of (5), no effect was observed within the dose range of Category 2. From the above, it was classified in Category 2 (respiratory organs). Besides, the guidance, tests of 14 days or longer should be generally adopted. However, based on that effects on the nasal cavity observed within 10 and 12 days, they were used for classification. [Evidence Data] (1) As a result of inhalation exposure of rats to 1,000 ppm of the vapor of this substance for 12 days, slight stimulus changes were observed in the nasal cavity (SIDS (2004)). They were findings at the converted guidance value of 0.39 mg/L within the range of Category 2. (2) As a result of inhalation exposure of rats to the vapor of this substance for 10 days, transitional epithelium hyperplasia of the anterior portion of the nasal cavity was observed at 2,500 ppm or higher (SIDS (2004)). It was a finding at the converted guidance value of 0.82 mg/L within the range of Category 2. (3) In a 13-week inhalation exposure test (500-8,000 ppm) and a 2-year inhalation exposure test (500-2,000 ppm) with rats, tissue changes were observed in the nasal cavity at concentrations (converted guidance value: 1.07 mg/L or higher) exceeding the range of Category 2 (NTP TR472 (1999), SIDS (2004), Environmental Risk Assessment for Chemical Substances Vol.8, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2010)). (4) Also in a 13-week inhalation exposure test and a 2-year inhalation exposure test with mice, tissue changes were observed in the nasal cavity at concentrations (converted guidance value: 2.13 mg/L or higher) exceeding the range of Category 2 (NTP TR472 (1999), SIDS (2004), Environmental Risk Assessment for Chemical Substances Vol.8, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2010)). (5) In a 90-day test with rats dosed by gavage, squamous epithelium hyperplasia in the boundary between the forestomach and glandular stomach was observed at or above 200 mg/kg/day exceeding the range of Category 2, and a decrease in uric pH value was observed at 600 mg/kg/day (Risk Assessment Report (Food additives) (Food Safety Commission of Japan, 2006), Environmental Risk Assessment for Chemical Substances Vol.8, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2010)).
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 3	- -	H402	P273 P501	It was classified in Category 3 from 96-hour LC50 = 23 mg/L for fish (Pimephales promelas) (OECD SIDS: 2004).
11	Hazardous to the aquatic environment (Long-term)	Not classified	- -	-	-	Chronic toxicity data were not obtained. It was classified as "Not classified" because it is rapidly degradable (readily biodegradable, a degradation rate by BOD: 81% (J-CHECK, 1979)), and no bioaccumulation is estimated (LogKow: 0.74 (EST, 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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