NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	95-33-0
Chemical Name	N-Cyclohexyl-2-benzothiazolesulfenamide
Substance ID	H30-B-013-MHLW, MOE
Classification year (FY)	FY2018
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

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	- -	-	-	Solid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Solid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Solid (GHS definition)
6	Flammable liquids	Not applicable	- -	-	-	Solid (GHS definition)
7	Flammable solids	Classification not possible	- -	-	-	No data available. Besides, it is described that it is poorly flammable (GESTIS (Accessed Aug. 2018)).
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 applicable	- -	-	-	Solid (GHS definition)
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 deg C) 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	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	Not applicable	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine.
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1)-(4), it was classified as "Not classified." [Evidence Data] (1) LD50 value for rats: > 5,000 mg/kg (EU-RAR (2008), SIDS SIAP (2008)) (2) LD50 value for rats: 5,300 mg/kg (EU-RAR (2008)) (3) LD50 value for rats: 6,850 mg/kg (EU-RAR (2008)) (4) LD50 value for rats: > 7,940 mg/kg (Patty (2012))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) LD50 value for rabbits: > 7,940 mg/kg (EU-RAR (2008), SIDS SIAP (2008), Patty (2012))
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	[Rationale for the Classification] Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Not applicable	- -	-	-	[Rationale for the Classification] Solid (GHS definition)
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)-(3), it was classified as "Not classified." [Evidence Data] (1) There is a report that irritation was not shown when a patch test was conducted on 200 people using this substance itself (EU-RAR (2008)). (2) There is a report that when a patch test was conducted with a 70% preparation of the substance (in petrolatum) to 51 people, erythema as a sign of irritation was observed in 8 people (EU-RAR (2008)). However, there are some information sources which judge that this is not irritating (PATTY (6th, 2012)). (3) There is a report that in a skin irritation test with rabbits (n=3/sex, GLP-compliant), after 24-hour semi-occlusive application of this substance (saline), erythema of score one was observed in 3 animals, but these resolved after 72 hours (EU-RAR (2008), REACH registration dossier (Accessed Aug. 2018)).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified" (Category 3 in UN GHS classification). [Evidence Data] (1) There is a report that in an eye irritation test with rabbits (n=3, GLP-compliant), after application of this substance, each score of iritis, corneal opacity and conjunctival edema was 0, and the score of conjunctival redness was 1.3, but these resolved within 96 hours (REACH registration dossier (Accessed Aug. 2018)). (2) There is a report that in an animal test with rabbits (n=3, males and females), after application of this substance, the Draize score of 1.8/110 was obtained, slight conjunctival redness and moderate secretion were observed in 5/6 animals after 24 hours, but these resolved after 48 hours (SIDS (2008), REACH registration dossier (Accessed Aug. 2018)). [Reference Data, etc.] (3) It is reported that this substance causes eye irritation by occupational exposure to humans (PATTY (6th, 2012)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] Based on (1) -(3), it was classified in Category 1. [Evidence Data] (1) There is a report that when a patch test was conducted with a 0.33% preparation of this substance (in a mixture of mercapto compounds) in 32 patients with rubber contact dermatitis, sensitization was observed in 3 patients (positive rate of 9%) (Allergen manual (Japanese Society for Contact Dermatitis)). (2) There is a report that when a patch test was conducted with a 70% preparation of the substance (in petrolatum) in 51 people, sensitization was observed in 5 people (EU-RAR (2008), PATTY (6th, 2012)). (3) It is reported in Spain, Poland, Denmark and India that this substance is sensitizing to humans (workers and consumers) (EU-RAR (2008)). [Reference Data, etc.] (4) There is a report that no sensitization was observed in a Buehler test (10 males and 10 females) with guinea pigs after using a 25% preparation of this substance (in ethanol) (EU-RAR (2008), PATTY (6th, 2012)). (5) This substance was classified as "Skin Sens. 1" by EU CLP and as Sh by DFG.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] There is no in vivo data. Therefore, classification was not possible due to lack of data. [Evidence Data] (1) As for in vitro, there are reports that the results of a bacterial reverse mutation test (PATTY (6th, 2012), SIDS (2008), JECDB (Accessed Aug. 2018)), and a mammalian cell gene mutation test (PATTY (6th, 2012), SIDS (2008)) and a mammalian cell chromosome aberration test (SIDS (2008), JECDB (Accessed Aug. 2018)) are negative.
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] As for carcinogenicity, there are no available reports on humans. From the results of animal studies, there is no evidence of carcinogenicity, and only limited evidence stating negative results of mice in (1). There are also no classification results by other organizations. Therefore, it was classified as "Classification not possible" due to lack of data. [Evidence Data] (1) In a study in which 2-strain male and female mice were orally given by gavage, 215 mg/kg/day for 21 days followed by 17 months in the diet (95.3 mg/kg/day), there was no difference in the survival rate between the treated group and the control group (EU-RAR (2008)). In addition, tumors were observed in all the groups, but no statistically significant difference was observed. (2) There are no classification results by domestic and international organizations.
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1)-(3), 3 test data in developmental toxicity tests with pregnant rats administered orally in their organogenesis period, are obtained. Decreased body weight gain in maternal animals and a reduced mean body weight of pups were also observed. In addition, in (1), developmental effects including malformations in pups were observed at or below doses where maternal toxicity occurred, but the EU concluded that the effects observed did not indicate a teratogenic potential because there are no available background data for the particular rat strain used in this study (EU-RAR (2008)). Therefore, it was classified in Category 2. [Evidence Data] (1) In a study in which DAK rats of gestational Day 6-15 were administered by gavage at 50, 150 and 450 mg/kg/day, for pups, by administration of 450 mg/kg/day, effects such as significantly increased frequency of early resorptions in litters, late resorptions per litter and increased postimplantation losses were observed. Dose-related increases in internal hydrocephalus were observed at or above 150 mg/kg/day (EU-RAR (2008)). (2) In a study in which rats of gestational Day 0-20 were administered by feeding at 0.7, 7.1, 69.6 and 288.8 mg/kg/day, in maternal animals, decreased body weight gain at or above 69.6 mg/kg/day, and decreased food consumption at 288.8 mg/kg/day were observed, and lower values of fetal and placenta weight were observed at 288.8 mg/kg/day (EU-RAR (2008)). (3) In a study in which rats of gestational Day 6-15 were administered by gavage at 100, 300 and 500 mg/kg/day, decreased body weight gain in maternal animals and lower values of fetal weight were observed at 500 mg/kg/day (EU-RAR (2008)).
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
9	Specific target organ toxicity - Repeated exposure	Category 2 (kidney)	Warning	H373	P260 P314 P501	[Rationale for the Classification] Based on (1), it was classified in Category 2 (kidney). The classification result was changed from the previous classification by using the new information sources. Besides, the haemal system was not adopted as the target organ because the effect on the blood observed in (2) is shortening of prothrombin time which is considered to be of lower toxicological significance. [Evidence Data] (1) Effects of administration of this substance on experimental animals were observed at or above 250 mg/kg/day and were concluded to be signs of a coagulopathy of the blood (male and female) and effects on the kidney (males) (EU-RAR (2008), SIDS SIAP (2008)). (2) In a study with rats dosed by gavage for 28 days, significant shortening of prothrombin time (male), an increase in urinary ketone bodies (males), and an increase in hyaline droplets in proximal tubular epithelium in the kidneys (male) were observed at or above 250 mg/kg/day (converted guidance value: 77.8 mg/kg/day) within the range of Category 2 (JECDB (Accessed Jul. 2018)). (3) In a 28-day inhalation exposure test (6 hours/day, 5 days/week) with rats, increased serum GOT (AST) activity (male and female) at or above 0.0144 mg/L (converted guidance value: 0.0032 mg/L) within the range of Category 1, and an increase in hemosiderin deposition in the spleen (female) and increased brown pigment within sinusoidal macrophages in the lymph nodes at 0.048 mg/L (Converted guidance value: 0.011mg/L) within the range of Category 1 were observed. Since there was no histological change in the liver, the increase in serum AST activity was judged not to be an adverse effect, and it was assumed that the increase in hemosiderin deposition in the spleen might be due to erythrocyte hemolysis, but the toxicological significance was judged to be low because of the no change in erythrocyte parameters (EU-RAR (2008)). (4) In a 21-day dermal exposure test with rabbits, no abnormality was observed even at the highest dose of 2,000 mg/kg/day (EU-RAR (2008)).
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 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 72-hour EC50 (growth rate) = 0.15 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2018)).
11	Hazardous to the aquatic environment (Long-term)	Category 1	Warning	H410	P273 P391 P501	It was classified in Category 1 because it is not rapidly degradable (not readily degradable, a degradation rate by BOD: 12% (J-CHECK, 1978)), and 72-hour NOEC (growth rate) = 0.0084 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 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.

To GHS Information