NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	81-88-9
Chemical Name	Rhodamine B
Substance ID	m-nite-81-88-9_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)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2010	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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2010	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)	- -	-	-	The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified	- -	-	-	Although the substance is an organic compound containing chlorine, since it is a "chlorine ion" which is ionically bonded to amine, it is not considered to have oxidizing properties.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2010	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	Based on the mouse LD50 value of 887 mg/kg bw (RTECS (2006), original literature: TOERD9 Toxicological European Research.1, 23, (1978)), the substance was classified as Category 4.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	The classification was not possible due to insufficient data available. As relevant notes, it was reported that the acute symptom (pain and itching of the skin) was complained by workers of the automotive maintenance shop who were exposed to the powder of the substance for about 30 minutes. The symptom disappeared in 63% of workers within 4 hours and for all within 24 hours. The symptom was transit irritation, and no aftereffect was noted (HSDB (2002), The EFSA Journal 263 (2005)). Based on the documents, the substance was considered to have skin irritation, but there was not sufficient information for the classification.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	The classification was not possible due to insufficient data available. As relevant notes, it was reported that the acute symptoms (burning of the eyes and excessive lacrimation) were complained by workers of the automotive maintenance shop who were exposed to the powder of the substance for about 30 minutes. The symptoms disappeared in 63% of workers within 4 hours and for all within 24 hours. Symptoms were transit irritation, and no aftereffect was noted (HSDB (2002), The EFSA Journal 263 (2005)). Based on the documents, the substance was considered to have eye irritation, but there was not sufficient information for the classification.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The classification was not possible due to lack of in vivo test data. As relevant information, as for in vitro studies, negative and positive results in the Ames test, positive results in the chromosome aberration test using fibroblast cells from muntjac were reported. However, the positive results of the Ames test were reported to be caused by the impurities (The EFSA Journal 263 (2005)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	The classification was concluded as "Classification not possible" based on the criterion of "Group 3" in the carcinogenicity assessment by the IARC (IARC 16 (1978). As relevant information, in the long-term (approximately 2-year) oral and dermal administration studies in rats and mice, no evidence of carcinogenicity of the substance was reported (IARC 16 (1978)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Classification not possible	- -	-	-	The classification was not possible due to lack of sufficient data. As relevant information, there were multiple reports that the teratogenicity was not observed in mouse, rat, rabbit, dog (HSDB (2002), Birth Defects, 3rd (2000), Teratogenic, 12th (2007)). However, the effects on sexual functions and fertility of parental animals were unknown.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 3 (Respiratory tract irritation)	Warning	H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	It was reported that workers of automobile maintenance shop who were exposed to the powder of the substance for about 30 minutes complained about acute symptoms containing nasal burning, chest pain and/or constriction, cough, dyspnea, burning of the throat, or heartburn (HSDB (2002), The EFSA Journal 263 (2005)). Based on the information, the substance was classified as Category 3 (respiratory tract irritation).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In the 18-week feeding study in rats (dose levels: 0, 0.1, 0.25, 0.5, 1.0 or 2.0%: 100, 250, 500, 1000 mg/kg/day), liver damage was observed in the highest dose group (IARC 16 (1987)). The doses tested were those equivalent to "Not classified" category, so the classification was not possible from these data only. In conclusion, the substance was judged as "Classification not possible" due to lack of sufficient data.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2010	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 3	- -	H402	P273 P501	Classified into Category 3 from its 48h-LC50 = 22.9 mg/L for crustacea (Daphnia magna) (AQUIRE, 2011).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 3	- -	H412	P273 P501	Classified into Category 3 since its acute toxicity is Category 3 and it is not rapidly degradable (Non-biodegradable, BOD degradation rate: 0% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 1987)).	FY2010	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.	FY2010	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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