NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	2602-46-2
Chemical Name	Disodium 6,6'-(Biphenyl-4,4'-diylbisazo)bis(4-amino-5-hydroxy-2,7-naphthalenedisulfonate); Direct Blue 6
Substance ID	m-nite-2602-46-2_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)	- -	-	-	It does not contain chemical groups (aliphatic azo group) associated with explosive properties.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	It does not contain chemical groups (aliphatic azo group) associated with explosive properties or those associated with self-reactive properties.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
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).	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
14	Oxidizing solids	Classification not possible	- -	-	-	It is an organic compound containing oxygen (but not fluorine or chlorine), which is chemically bonded to sulfur. Since no test results based on standardized testing methods are available, classification is not possible.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
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)	Not classified	- -	-	-	Based on the report that rat LD50 = 8.76 g/kg (HSDB, 2003), the substance was classified into the "Not classified" category.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on the report that rabbit LD50 >= 8.0 g/kg (HSDB, 2003), the substance was classified into the "Not classified" category.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	Since no mortality was observed in rats exposed to approx. 154 mg/L for 1 hour (HSDB, 2003), we determined that LC50 is > 154 mg/L (1 hour). The estimated LC50 for 4-hour exposure= 1 hour*(> 154 mg/L)/4 hours = > 38.5 mg/L. Consequently, using classification criteria for dust, the substance was classified into the "Not classified" category.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
5	Germ cell mutagenicity	Classification not possible	- -	-	-	In treated rats, DNA adduct formation and DNA damage were observed (RTECS, accessed in October 2007), and mouse lymphoma test gave positive results (NTP DB, accessed in October 2007). However, these positive results are considered to not act as sufficient evidence in terms of reliability. Thus, classification is not possible due to insufficient test results available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	It is rated as "2A" by Japan Society for occupational Health (2007) and "2" by the EU (2007). Based on these ratings, the substance was classified into Category 1B.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	Mice were administered this substance at dose levels of 0, 50, 75, 100, or 200 mg/kg/day (administration route not provided) on days 6 through 15 of gestation, and a Cesarean section was performed on day 18 of gestation (HSDB (2003)). Decreased weight gain was observed in parental animals administered at 100 mg/kg/day or above, and cleft palates and wavy ribs were noted in the offspring administered at 75 mg/kg/day (HSDB (2003)). In this study, since malformations were observed in the offspring at doses that did not affect parental animals, the substance was classified into Category 1B.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	Classification not possible due to lack of data. As additional background information, in rats administered single doses of the substance through forced oral administration, congestion of the lungs was reported (HSDB, 2003). Also there are other studies indicating adverse effects of this substance. However, these studies do not explain the relationship between doses and their effects. Consequently, classification is not possible based on these studies.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
9	Specific target organ toxicity - Repeated exposure	Category 2 (liver)	Warning	H373	P260 P314 P501	In a 13-week mixed diet administration test using rats, biliary hyperplasia was noted (NTP TR 108, 1978). Evaluating this report, we determined that the liver is the target organ of this substance, and this effect was seen at doses that fall under the range of Category 2 guidance values. Thus, the substance was classified into Category 2 (liver).	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）

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)	Classification not possible	- -	-	-	Its 96-hour LC50 is > 180 mg/L for fish (fathead minnow) (ECOTOX, 2007). As its water solubility is 0.000137 mg/L (SRC, 2005), classification is not possible based on these test results.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
12	Hazardous to the ozone layer	-	- -	-	-	-	-	-

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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