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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	89-72-5
Chemical Name	o-sec-Butylphenol
Substance ID	H26-B-027, R-064
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	Not classified	- -	-	-	From a flash point of 107 deg C (unknown test methods) (ICSC (2002)), it was judged to be above 93 deg C also in prescribed test methods. Therefore, it was classified as "Not classified."
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 270 deg C (GESTIS (Access on July 2014)).
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. Besides, there is information that because this substance is corrosive to steel, it is not suitable 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)	Category 4	Warning	H302	P301+P312 P362+P364 P264 P270 P330 P501	There are 5 reports of LD50 values of 320 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.9, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2011)), 340 mg/kg (SIDS (2013)), 500-1,000 mg/kg (JECDB (Access on July 2014), SIDS (2013)), 200-2,000 mg/kg (SIDS (2013)) and 2,700 mg/kg (ACGIH (7th, 2001)) for rats. It was classified in Category 4 to which the larger number of data (3 cases) corresponded according to the revised GHS classification guidance for the Japanese government. Besides, the remaining values corresponded to Category 3 or Category 4 or "Not Classified," respectively.
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on a report of an LD50 value of 5,560 mg/kg for rabbits (SIDS (2013)), it was classified as "Not classified."
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, although there is a report of an LC50 value (4 hours) of >1.78 mg/L for rats (Environmental Risk Assessment for Chemical Substances Vol.9, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2011), SIDS (2013)), classification could not be specified.
2	Skin corrosion/irritation	Category 1	Danger	H314	P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501	In a skin irritation test (OECD TG 404) with rabbits, by application of 0.5 mL of the undiluted liquid of this substance for 3 minutes, moderate to severe edema was observed 1 hour after administration and slight edema was observed 7 days after administration, therefore, it is judged that it was a corrosive substance (SIDS (2013)). In addition, there is a report that it was corrosive in another test with rabbits (SIDS (2013)). Moreover, there is a report that skin burns occurred in occupational exposures (ACGIH (7th, 2001)). From the above, it was classified in Category 1. Besides, in the animal tests, since there were no descriptions on details such as the scores, sub-categorization was not conducted.
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	In a Draize test with rabbits, after application of 0.5 mL of the undiluted liquid of this substance to the eyes, it was corrosive (SIDS (2013)). In addition, there was a report that in another study with rabbits, severe eye injury was observed (ACGIH (2001)). From the above, it was classified in Category 1.
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, it was negative in a micronucleus test with rat bone marrow cells (JECDB (Access on June 2014), SIDS (2013)). As for in vitro, it was negative in a bacterial reverse mutation test, and it was positive in a chromosomal aberration test with cultured mammalian cells (JECDB (Access on June 2014), SIDS (2013), NTP DB (Access on July 2014)).
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.
7	Reproductive toxicity	Classification not possible	- -	-	-	There is a report that in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats dosed orally (gavage), no reproductive and developmental effects (copulation rate, fertility index, maintenance of pregnancy in female animals, delivery and lactation and viability, sex ratio, development and morphology in offspring) were observed (JECDB (Access on June 2014), SIDS (2013)). However, since it was a screening toxicity test and there were insufficient data on developmental toxicity including teratogenicity, 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	In humans, this substance was irritating to the respiratory tract (ACGIH (7th, 2001), Environmental Risk Assessment for Chemical Substances Vol.9, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2011)) and may cause slight inflammation of the respiratory tract. There are reports of burning sensation of the pharynx and chest, abdominal pain, vomiting, shock or collapse by the oral ingestion, and cough and sore throat in the inhalation (Environmental Risk Assessment for Chemical Substances Vol.9, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2011)). In rats, since decreased locomotor activity, prone position, lateral position, crouching position, abnormal gait, decreased respiratory rate, respiratory murmur, tachypnea, salivation and death were observed by oral administration at 500-2,000 mg/kg, target organs were described as respiratory organs and digestive system (JECDB (Access on June 2014), SIDS (2013)). In addition, by oral administration to rats, salivation, ptosis and coma at 2,000-5,000 mg/kg and sluggishness, drowsiness and decreased respiratory rate at 85-1,370 mg/kg were reported (SIDS (2013)). However, in these tests, the direct effect on the respiratory organs was considered to be only respiratory murmur, and this respiratory murmur occurred only in 1 of 18 deaths. Therefore, here, it was not judged to be an effect by administration of this substance. In addition, the effects on the digestive system were considered to be due to irritation. From the above, this substance was considered to cause respiratory tract irritation and narcotic effects, therefore, it was classified in Category 3 (respiratory tract irritation, narcotic effects).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats dosed by gavage, although no effects by administration of the test substance were observed except for decreased locomotor activity in males early in the treatment period at 60 mg/kg/day (converted guidance value: 28 mg/kg/day), clinical symptoms such as decreased locomotor activity and prone position and increased relative liver weight in males and females, hypertrophy of the centrilobular hepatocytes in males were observed at 300 mg/kg/day (converted guidance value: 140-163 mg/kg/day) (JECDB (Access on June 2014), SIDS (2013)). Although clear effects were observed in the treatment group of 300 mg/kg/day, it is not clear whether the effects were observed at the upper limit dose of Category 2 or not, therefore, the results in this test were not available for classification. There were no other data available for classification. Therefore, classification was 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 2	- -	H401	P273 P501	It was classified in Category 2 from 96-hour LC50 = 1.3 mg/L for crustacea (Crangon septemspinosa) (SIDS, 2013).
11	Hazardous to the aquatic environment (Long-term)	Category 2	-	H411	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 2 due to being not rapidly degradable (a degradation rate by BOD: 0% (SIDS, 2013)), and 21-day NOEC = 0.32 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1998), SIDS, 2013). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 2 due to being not rapidly degradable (a degradation rate by BOD: 0% (SIDS, 2013)), and 96-hour LC50 = 6 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1998), SIDS, 2013). From the above results, it was classified in Category 2.
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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