NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	26530-20-1
Chemical Name	2-n-Octyl-4-isothiazolin-3-one
Substance ID	m-nite-26530-20-1_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	It is a liquid at normal temperatures (Merck (14th, 2006)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not an aerosol product.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	It is a liquid at normal temperatures (Merck (14th, 2006)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	It is a liquid at normal temperatures (Merck (14th, 2006)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	It is a liquid at normal temperatures (Merck (14th, 2006)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	It is a liquid at normal temperatures (Merck (14th, 2006)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No established test method suitable for liquid substances.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	Not containing metals or semimetals (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	An organic compound that contains oxygen which is not chemically bonded to elements other than carbon.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	It is a liquid at normal temperatures (Merck (14th, 2006)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	An organic compound that does not contain -O-O- structure.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	All reported seven LD50 values for rats (708 mg/kg, 562 mg/kg, 794 mg/kg, 681 mg/kg, 735 mg/kg, 355 mg/kg, 358 mg/kg) (DFGMAK-Doc. 16 (2001)) correspond to Category 4.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P361+P364 P280 P312 P321 P405 P501	Because the higher hazard category between two reported LD50 values for rabbits (311 mg/kg and about 1800 mg/kg) (DFGMAK-Doc. 16 (2001)) which correspond to Category 3 and Category 4 was adopted, it was classified in Category 3.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	It is a liquid at normal temperatures (Merck (14th, 2006)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Category 3	Danger	H331	P304+P340 P403+P233 P261 P271 P311 P321 P405 P501	From an LC50 value of 0.586 mg/L/4h for rats (DFGMAK-Doc. 16 (2001)), it was classified in Category 3. Besides, a reference value of mists was applied because exposure to an aerosol was described (DFGMAK-Doc. 16 (2001)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
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	From severe erythema and edema accompanied by scab formation and tissue damage, a maximal score of 8.0, and "corrosive" classification in a test applied 0.5 mL of a 45 to 50% solution in propylene glycol to rabbit skins for 4 hours (DFGMAK-Doc. 16 (2001)), it was classified in Category 1.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	From severe irritation to the conjunctiva, cornea, and iris persisted for longer than 7 days and "corrosive" classification in a test applied 0.1 mL of a 45% solution into rabbit conjunctival sac (DFGMAK-Doc. 16 (2001)), it was classified in Category 1. Besides, this substance is also classified as a corrosive substance to skins.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Category 1A	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	A maximization test in guinea pigs concluded from a positive rate of 25% (5/20) in a 0.2% solution, 35% (7/20) in a 0.1% solution on day 21 provocation after induction, and 40% (8/20) in a 0.1% solution on day 35 that it is a moderately sensitizing substance. (DFGMAK-Doc. 16 (2001)) On the other hand, there are many reports as follow: A case of a person who developed an allergic reaction to occupational exposure had a positive in a patch test. (DFGMAK-Doc. 16 (2001)) A case of a patient with eczema who had a positive in a patch test to this substance or a substance including this substance. (DFGMAK-Doc. 16 (2001)) A case where provocation caused allergic reactions in human subjects in a cumulative patch test. (DFGMAK-Doc. 16 (2001)) Furthermore, it is listed as a sensitizing substance in Contact Dermatitis (Frosch) (Contact Dermatitis (Frosch) (4th, 2006), corresponding to List 1). From the above, it is classified in Category 1A because high frequent human cases were reported and 35 to 40% of animals responded to the concentration of 0.1% in the maximization test in guinea pigs.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Not classified	- -	-	-	It was classified as "Not classified" due to a negative without the increase of structural chromosomal aberrations in a chromosome aberration test using rat bone marrow (in vivo somatic cell mutagenicity test) (DFGMAK-Doc. 16 (2001)). Besides, as in vitro tests, a negative in an Ames test, a positive in a chromosome aberration test using CHO cells, and a negative in an HPRT gene mutation test using CHO cells were reported respectively (DFGMAK-Doc. 16 (2001)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	Lack of data. Besides, in an 18-month diet administration test in mice, it is reported that incidences of lymphosarcomas, liver cell carcinomas, fibroadenomas, and pulmonary adenomas observed in a high-dose group at 1000 ppm did not differ from that of spontaneous neoplasms in a control group (DFGMAK-Doc. 16 (2001)). But the classification is not possible due to no other data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Classification not possible	- -	-	-	In oral administration tests in rats and rabbits during an organogenetic period, a decreased weight gain as general maternal toxicity was observed. But neither clear evidence of fetal toxicity nor adverse effects on the development of the offspring in both species except a slight increase in early resorptions not accompanied by post-implantation losses in a high dose in rats were reported. (DFGMAK-Doc. 16 (2001)) But, it was classified as "Classification not possible" due to lack of data on effects on sexual function and fertility in parent animals.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system, respiratory system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	In an oral administration test in rats, decreased activity at doses of 31.6 mg/kg and more, ataxia at 316 mg/kg and more, and losses of righting reflex at 1000 mg/kg and more were observed. And in another test, CNS depression and a hunched posture at 500 mg/kg and more, and tremor and prostration at 1000 mg/kg and more were observed. On the other hand, apathy, ataxia, prostration, and partial paresis of the hind limbs at 291 mg/kg and more in dermal administration to rabbits, and CNS depression symptoms such as ataxia, prostration, and apathy at 94 mg/m3 and more in inhalation administration (mist) to rats were reported. (DFGMAK-Doc. 16 (2001)) From the above, it was classified in Category 1 (central nervous system) because symptoms occurred within a dose range of Category 1 in Guidance values. Furthermore, in an inhalation administration test, dyspnea, bradypnea, and breathing noises were observed at 58 mg/m3/4h (mist) and more, and the lung changes at 229 to 671 mg/m3/4h in a gross pathological examination as the only finding significantly different from the historical control values were described. (DFGMAK-Doc. 16 (2001)) Therefore it was classified in Category 1 (respiratory system).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory tract)	Danger	H372	P260 P264 P270 P314 P501	Because in a 90-day inhalation exposure test (6 hours/day) (0.05, 0.64 and 6.39 mg/m3 (mist)) using rats, dyspnea, bradypnea, secretory cell hyperplasia of the septal mucosa, neutrophilic infiltration of the mucosa, squamous metaplasia of the respiratory epithelium, intraepithelial droplets in the nasal cavity were observed (DFGMAK-Doc. 16 (2001)) in a high-dose group at 6.39 mg/m3 corresponding to a range of Category 1 in Guidance values, it was classified in Category 1 (respiratory tract). Neither dose-related effects in 90-day diet administration in rats up to a dose of 115 mg/kg bw/day (DFGMAK-Doc. 16 (2001)) nor apparent dose-related changes in necropsy and a pathological test in 90-day dermal administration in rats up to a dose of 14.87 mg/kg/day except occasional changes in blood and biochemical tests (DFGMAK-Doc. 16 (2001)) were reported.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Category 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 96-hour LC50 = 0.047 mg/L for fish (Oncorhynchus mykiss) (U.S. EPA: RED, 2007).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	It was classified in Category 1 due to lack of rapid degradability (BIOWIN) and MATC = 0.012 mg/L in an early life stage test (ELS) for fish (Pimephales promelas) (U.S. EPA: RED, 2007).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）

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.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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