NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	10222-01-2
Chemical Name	2,2-Dibromo-2-cyanoacetamide (2,2-Dibromo-3-nitrilopropionamide)
Substance ID	H30-B-002-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	- -	-	-	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	Not classified	- -	-	-	It is not combustible (HSDB (Accessed Sept. 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	Not classified	- -	-	-	It is not combustible (HSDB (Accessed Sept. 2018)).
11	Self-heating substances and mixtures	Not classified	- -	-	-	It is not combustible (HSDB (Accessed Sept. 2018)).
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	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
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)	Category 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	[Rationale for the Classification] Based on (1)-(4), three cases correspond to Category 3, and one case corresponds to Category 4. It was classified in Category 3 adopting a category with the largest number of cases. [Evidence Data] (1) LD50 for rats: 178 mg/kg (EPA Pesticide (1994)) (2) LD50 for rats: 235 mg/kg (EPA Pesticide (1994)) (3) LD50 for rats: 284 mg/kg (female) (EPA Pesticide (1994)) (4) LD50 for rats: 375 mg/kg (male) (EPA Pesticide (1994))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified" (corresponding to Category 5 or "Not classified" in UN GHS classification). [Evidence Data] (1) LD50 for rabbits: > 2,000 mg/kg (male) (EPA Pesticide (1994)) (2) LD50 for rabbits: > 2,000 mg/kg (male and female) (EPA Pesticide (1994))
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	[Rationale for the Classification] Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Category 2	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	[Rationale for the Classification] Based on (1), it was classified in Category 2. Besides, the test concentration was higher than 90% of the saturated vapor concentration, 1.07 ppm (0.01 mg/L), so the reference values of the dust were applied. [Evidence Data] (1) LC50 of a 4-hour inhalation with rats (4 hours): 0.32 mg/L (EPA Pesticide (1994))
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	[Rationale for the Classification] Based on (1), (2), it was classified in Category 2. [Evidence Data] (1) There is a report that in a skin irritation test (OECD TG404, GLP-compliant) in which 0.5 g of this substance (purity 98.2%) was applied to rabbits for 4 hours, the mean scores of 3.3 for erythema and 2.1 for edema were obtained, but they resolved after 14 days (EU CLH proposal document (2018)). (2) There is a report that in a skin irritation test in which 0.5 g of this substance was applied to rabbits for 4 hours, erythema and edema occurred, and detachment of the epidermis was observed after 5 days. Based on this, it is judged as moderate skin irritation (EPA Pesticide (1994)).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1. [Evidence Data] (1) There is a report that serious corneal damage considered to be an irreversible effect was observed in all the animals in an eye irritation test with rabbits (EPA Pesticide (1994)). (2) There is a report that in an eye irritation test with rabbits (OECD TG405), this substance showed corrosivity, with the opacity showing a maximum value within 1 hour (EPA Pesticide (1994), EU CLH proposal document (2018)). [Reference Data, etc.] (3) EPA concluded that this substance is a corrosive substance (EPA Pesticide (1994)).
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)-(4), it was classified in Category 1. Besides, there exist both data for classification in Category 1A ((1), (2)) and those for classification in Category 1B ((4)), so it was judged that the data are insufficient to subcategorize, and it was classified in Category 1. [Evidence Data] (1) Based on a report that in a test similar to the Buehler test with guinea pigs, a 2% preparation (in acetone) of this substance was applied 3 times in total for 6 hours to induce, and the animals then challenged 29 days later, a positive reaction was observed in 6 of the 20 animals, it is judged that this substance is weakly sensitizing (EU CLH proposal document (2018)). (2) There is a report that in sensitization tests (2 cases) with guinea pigs, in which a 5% preparation (in a 9:1 mixture of DOWANOL DPM and Tween 80) of this substance (purity unknown) was applied to induce twice a week for 3 weeks, and then applied to challenge 2 weeks later, positive results were observed in 7 of the 10 animals (EU CLH proposal document (2018)). (3) Based on reports that weakly positive reactions were observed in skin sensitization tests (2 cases) with guinea pigs, EPA judged that this substance is a skin sensitizer (EPA Pesticide (1994)). (4) In a Buehler test (OECD TG 406, GLP-compliant) with guinea pigs, in which the animals were induced with a 25% preparation (in 0.5% Methocel) of this substance (98.2% purity) a total of 3 times for 6 hours each while in the case of the challenge with a 0.5% preparation (in 0.5% Methocel) all 10 animals were negative, in the case of the challenge with a 5% preparation (in 0.5% Methocel) positive results were observed in all 10 animals. But at the latter dose, responses were also observed in the naive control group, therefore, it was judged that the reaction was due to irritation (EU CLH proposal document (2018)). (5) There are multiple data showing sensitization in humans, but due to the limited number of samples or because the details of these studies including information on the test substance are unknown, the sponsor country, Denmark, considered that subcategorization cannot be judged from human data (EU CLH proposal document (2018)). [Reference Data, etc.] (6) Skin Sens. 1 was proposed as a harmonized classification in May 2018 in the EU CLH proposal document.
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, it was negative in a bacterial reverse mutation test, a mammalian cell gene mutation test and an unscheduled DNA synthesis test with rat hepatocytes, and it was weakly positive in a chromosomal aberration test with human lymphocytes (EPA Pesticide (1994)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] There are no available reports in humans for carcinogenicity. Although there is information of (1), classification was not possible due to lack of data. [Evidence Data] (1) No treatment-related increase in the incidence of tumors was observed in a carcinogenicity test with rats dosed by feeding for 2 years (EU CLH proposal document (2018)). (2) There are no classification results by domestic and international organizations.
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] According to (1), no effects on fertility were detected in a two-generation reproductive toxicity test with rats. On the other hand, according to (2), since the finding was not adopted as evidence for classification because it was regarded as slight developmental effects according to the GHS Classification Guidance for the Japanese Government, there is no information on developmental effects. Therefore, classification was not possible due to lack of data. [Evidence Data] (1) There is a report that in a two-generation reproductive toxicity test with rats by oral route (gavage), severe toxicity such as dyspnea and death occurred in parental animals by administration of high dose (40 mg/kg/day), but no adverse effect on fertility was observed in parental animals and pups even at lower doses (CLH proposal document (2018)). (2) There is a report that in a developmental toxicity test with pregnant rabbits dosed by gavage on organogenesis period (gestational Day 7-19), in maternal animals, deaths, decreased body weight gain, and decreased food consumption were observed at 60 mg/kg/day of the highest dose, but no abnormality was observed at 30 mg/kg/day of the middle dose, and in fetuses, delayed ossification (multiple bones) was observed at or above 30 mg/kg/day (EPA Pesticide (1994)).
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 (1), it was classified in Category 3 (respiratory tract irritation). [Evidence Data] (1) There is a description of accident cases in which irritation symptoms of the eye, throat and respiratory tract, runny nose and headache occurred in humans who spilled or misused preparations of this substance (EPA Pesticide (1994)).
9	Specific target organ toxicity - Repeated exposure	Category 2 (systemic toxicity)	Warning	H373	P260 P314 P501	[Rationale for the Classification] Because the target organ that showed toxicity could not be identified in (1), it was classified in Category 2 (systemic toxicity). [Evidence Data] (1) There is a report that in a test with rats dosed by gavage for 90 days, some animals with reduced body weight and dyspnea died at 13 and 30 mg/kg/day within the range of Category 2 (EPA Pesticide (1994)). [Reference Data, etc.] (2) In a dermal application test with rats for 90 days, at 309 mg/kg/day exceeding the range of Category 2, local irritation of application sites, and at 1,031 mg/kg/day, abnormal blood biochemistry values and an increase in urine pH were observed (EPA Pesticide (1994)).
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 96-hour LC50 = 0.72 mg/L for crustacea (Mysidopsis bahia) (EPA RED: 1994).
11	Hazardous to the aquatic environment (Long-term)	Category 1	Warning	H410	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 1 due to being not rapidly degradable (not readily degradable, an average degradation rate by BOD: 0% (J-CHECK, 2001)), and 28-day NOEL (unknown effects) < 0.02 mg/L for crustacea (Daphnia magna) (EPA RED: 1994). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 1 due to being not rapidly degradable (not readily degradable, an average degradation rate by BOD: 0% (J-CHECK, 2001)), and 96-hour LC50 = 1.0 mg/L for fish (Oncorhynchus mykiss) (EPA RED: 1994). From the above results, it was classified in Category 1.
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