GHS Classification Result

Chemical Name:Rhodamine B
CAS:81-88-9

Result:
ID: 22A4118
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2010
Reference Manual: GHS Classification Guidance by the Japanese Government (July, 2010)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement 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.
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 - - - - 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 (GHS definition)
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.
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure.
16 Corrosive to metals Classification not possible - - - - Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Category 4 Warning H302: Harmful if swallowed P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P330: Rinse mouth.
P501: Dispose of contents/container to ...
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.
1 Acute toxicity (Dermal) Classification not possible - - - - No data available.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible - - - - No data available.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - - No data available.
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.
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.
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 - - - - 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)).
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)).
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.
8 Specific target organ toxicity - Single exposure Category 3 (Respiratory tract irritation) Warning H335: May cause respiratory irritation (respiratory tract irritation) P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
P405: Store locked up.
P501: Dispose of contents/container to ...
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).
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.
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) Category 3 - - H402: Harmful to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ...
Classified into Category 3 from its 48h-LC50 = 22.9 mg/L for crustacea (Daphnia magna) (AQUIRE, 2011).
11 Hazardous to the aquatic environment (Long-term) Category 3 - - H412: Harmful to aquatic life with long lasting effects P273: Avoid release to the environment.
P501: Dispose of contents/container to ...
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)).
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


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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