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EC number: 282-468-8 | CAS number: 84229-70-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Endpoint summary
Administrative data
Description of key information
The test substance is practically non-toxic.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25.05. to 08.06. 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Internal Guideline Hoechst AG
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: -
- Weight at study initiation: 191 to 202 g
- Fasting period before study: 16 hours before to 2 hours after dosing
- Housing: group-caging (10/cage)
- Diet: Altromin 1324 ad libitum
- Water: tap ad libitum
- Acclimation period: -
IN-LIFE DATES: From: 25. May To: 08. June 1982 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25%
- Amount of vehicle (if gavage): 20 mL/kg - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: body weight: weekly; clinical signs: at least daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- -
- Preliminary study:
- NA
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- no deaths
- Clinical signs:
- other: no effects
- Gross pathology:
- no effects
- Other findings:
- Within 15 minutes after dosing all animals showed bluish discoloration of skin, apathia, bluish discoloration of feces and diarrhea. 25 minutes after application the animals showed hunched and prone position and piloerection as well as bluish urine. All effects were fully reversible within 24 hours.
Behaviour and gain of body weight were not effected during the recovery period. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 above 5000 mg/kg bw.
No classification necessary - Executive summary:
A study was conducted to assess the acute oral toxicity of the test substance in rats after a single dose with a 14-day post observation period. Ten fasted female Wistar rats received a single oral (gavage) dose of 5000 mg/kg bw. A 25% suspension of test substance was prepared in softened water and administered at a volume of 20 mL/kg bw.
No mortality occurred. Fifteen minutes after test substance administration,all treated rats showed apathia, blue skin blue faeces and diarrhea. After 25 minutes, hunched posture, prone position, piloerection and bluish discoloured urine was observed.
No clinical signs of toxicity were observed from 24 hours onward and no significant macroscopic abnormalities were seen at necropsy.
Under the study conditions, the oral LD50 was found to be >5000 mg/kg bw in rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From June 05, 2002 to June 19, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD Guideline 402, EU Method B.3 and EPA OPPTS 870.1200 Method, in compliance with GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Gartenstrasse 27, D-33178 Borchen
- Age at study initiation: 6 to 10 weeks
- Weight at study initiation: Males: mean=266.2 g (=100%) (S.D.=±12.7 g); female animals: mean=219.4 g (= 100%) (S.D.=±7.5 g)
- Housing: In transparent macrolon® cages (type III) on soft wood granulate in an air-conditioned room, 1 animal per cage
- Diet: Ssniff® R/M-H (V 1534), ad libitum
- Water: Tap water in plastic bottles, ad libitum
- Acclimation period: At least 5 d
-Animal identification: Cage numbering
-Randomization procedure: Computer generated algorithm (archived with raw data) randomization schemes 2001.0453 and 2001.0455
ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C (except short lasting deviations due to disturbances of air condition)
- Humidity: 50±20 % (except short lasting deviations due to disturbances of air condition)
- Photoperiod: 12 h light/dark cycle
IN-LIFE DATES: From: To: June 05, 2002 to June 19, 2002 - Type of coverage:
- occlusive
- Vehicle:
- other: sesame oil
- Details on dermal exposure:
- TEST SITE
Before dermal treatment the fur was mechanically removed from the dorsal skin of the animals over an area of approximately 30 cm². The appropriate amountof the test substance was moistened on a two-ply gauze and an aluminum foil (6 x 8 cm) and distributed as uniformly as possible. Together with the foil the test substance was administered to the shaved and intact dorsal skin. The foil was held in place with an elastic plaster bandage fixed around the animal's body (Fixomull and Elastoplast, 8 cm in width, both manufactured by Beiersdorf Aktiengesellschaft).
REMOVAL OF TEST SUBSTANCE
At the end of the dermal exposure period of 24 h the bandage was removed and the treated skin area washed with warm water in order to remove any unabsorbed remnants of the test substance.
PREPARATION OF THE TEST SUBSTANCE
0.5 g of test substance was moistened with 0.25 mL sesame oil - Duration of exposure:
- 24 h
- Doses:
- 2,000 mg/kg bw
- No. of animals per sex per dose:
- Five/sex/dose
- Control animals:
- not specified
- Details on study design:
- The observation period after the dermal administration lasted for 14 d.
Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays only once. During this time the animals were weighed weekly. At the end of the observation period the animals were killed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the whole study
- Clinical signs:
- other: No symptoms were observed after administration of test substance. The skin of the animals was discolored by the test substance from 2 d onwards. However, in most animals the discoloration disappeared at 6 d of the study. Only two females showed persistent
- Gross pathology:
- The animals killed at the end of the observation period showed no macroscopically visible changes.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the study conditions, the dermal LD50 of the test substance was found to be >2,000 mg/kg bw in rats
- Executive summary:
A study was conducted to assess the acute dermal toxicity of the test substance in Hsd:Sprague Dawley (SD) rats according to OECD Guideline 402, EU Method B.3. and EPA OPPTS 870.1200, in compliance with GLP.
Groups of five female and five male rats received a single dermal dose of 2,000 mg/kg bw.
500 mg of test substance was moistened with 0.25 mL sesame oil and was applied topically under occlusive conditions for 24 h.
No mortality occurred, no clinical symptoms were observed and no significant macroscopic abnormalities were seen at necropsy. Body weight was also not impaired. However, the skin of the animals was discolored by the test substance from 2 d onwards. Except in two females, discoloration disappeared in all other treated animals at 6 d of the study.
Under the study conditions, the dermal LD50 of the test substance was found to be >2,000 mg/kg bw in rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
A study was conducted to assess the acute oral toxicity of Reactive Blue 203 in rats after a single dose with a 14-day post observation period. Ten fasted female Wistar rats received a single oral (gavage) dose of 5000 mg/kg bw. A 25% suspension of test substance was prepared in softened water and administered at a volume of 20 mL/kg bw.
No mortality occurred. Fifteen minutes after test substance administration,all treated rats showed apathia, blue skin blue faeces and diarrhea. After 25 minutes, hunched posture, prone position, piloerection and bluish discoloured urine was observed.
No clinical signs of toxicity were observed from 24 hours onward and no significant macroscopic abnormalities were seen at necropsy.
Under the study conditions, the oral LD50 was found to be >5000 mg/kg bw in rats.
The acute dermal toxicity of Reactive Blue 203 was assessed via read-across from Structural Analogue 01 performed according to OECD 402. Groups of five female and five male rats received a single dermal dose of 2000 mg/kg bw.
500 mg of test substance was moistened with 0.25 mL sesame oil and was applied topically under occlusive conditions for 24 h.
No mortality occurred, no clinical symptoms were observed and no significant macroscopic abnormalities were seen at necropsy. Body weight was also not impaired. However, the skin of the animals was discolored by the test substance from 2 day onwards. Except in two females, discoloration disappeared in all other treated animals at 6 d of the study.
Under the study conditions, the dermal LD50 of the test substance was found to be >2000 mg/kg bw in rats.
Inhalative exposure of workers to Reactive Blue 203 is very unlikely, as production and spray drying is done in a closed process without isolation of reaction products. The isolated products are liquid, dust free granules or dedusted powders (non-dusty solid) therefore inhalative exposure of down-stream users is very unlikely.
Justification for classification or non-classification
No classification necessary.
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