GHS Classification Result

Chemical Name:Disodium 6,6'-(Biphenyl-4,4'-diylbisazo)bis(4-amino-5-hydroxy-2,7-naphthalenedisulfonate); Direct Blue 6
CAS:2602-46-2

Result:
ID: 55
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2007
Reference Manual: GHS Classification Manual (10 Feb, 2006)
Technical Guidance Document on the GHS Classification (6 Dec, 2005)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - It does not contain chemical groups (aliphatic azo group) associated with explosive properties.
2 Flammable gases (including chemically unstable gases) Not applicable - - - - Solid
3 Aerosols Not applicable - - - - Not aerosol products.
4 Oxidizing gases Not applicable - - - - Solid
5 Gases under pressure Not applicable - - - - Solid
6 Flammable liquids Not applicable - - - - Solid
7 Flammable solids Classification not possible - - - - No data available.
8 Self-reactive substances and mixtures Not applicable - - - - It does not contain chemical groups (aliphatic azo group) associated with explosive properties or those associated with self-reactive properties.
9 Pyrophoric liquids Not applicable - - - - Solid
10 Pyrophoric solids Classification not possible - - - - No data available.
11 Self-heating substances and mixtures Classification not possible - - - - No data 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
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.
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure
16 Corrosive to metals Classification not possible - - - - No data available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
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.
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.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Solid
1 Acute toxicity (Inhalation: Vapours) Classification not possible - - - - No data available.
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.
2 Skin corrosion/irritation Classification not possible - - - - No data available.
3 Serious eye damage/eye irritation Classification not possible - - - - No data available.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - No data available.
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.
6 Carcinogenicity Category 1B Danger H350: May cause cancer P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
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.
7 Reproductive toxicity Category 1B Danger H360: May damage fertility or the unborn child P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
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.
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.
9 Specific target organ toxicity - Repeated exposure Category 2 (liver) Warning H373: May cause damage to organs through prolonged or repeated exposure (liver) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ...
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).
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (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.
11 Hazardous to the aquatic environment (Long-term) Classification not possible - - - - No data available.


NOTE:
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.

Reference:
Reference Manual

Definitions / Abbreviations

Model Label by MHLW

MHLW Website (in Japanese Only)

Model SDS by MHLW

MHLW Website (in Japanese Only)


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