Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 277-257-2 | CAS number: 73049-92-0
Endpoint summary
Administrative data
Description of key information
Reactive Blue 21 is practically non-toxic. The LD50 for oral administration is above 5000 mg/kg body weight.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted comparable to guidelines
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- 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
- rats Hoe WISKf(SPF71)
- Weight at study initiation: 160 - 178 g
- Fasting period before study:16 hours before gavage application and 2 hours after
- Housing: in macrolon cages on soft wood granulate
- Diet : Altromin 1324 rat diet, ad libitum
- Water : ad libitum
Start of study: November 26, 1979
End of study: December 10, 1979 - Route of administration:
- oral: gavage
- Vehicle:
- other: starch/water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25% - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 female rats
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Clinical signs: multiple times on Day 0 and daily for 14 days thereafter
- Body weight: weekly
- Necropsy of survivors performed: yes - Statistics:
- -
- Preliminary study:
- NA
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- no deaths
- Clinical signs:
- no clinical signs
- Body weight:
- no effects
- Gross pathology:
- no effects
- Other findings:
- kidney cortex discoloured turquoise
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral medial lethal dose is above 5000 mg/kg bw in female Hoe:WISKf(SPF71) 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
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The acute oral medial lethal dose is above 5000 mg/kg bw in female Hoe:WISKf(SPF71) rats. The kidney cortex was discoloured, but no other turquoise but no other clinical signs or effects were determined.
No local or systemic effects were noted in local irritation studies in rabbits. As the physico-chemical properties of the test item is indication of a poor dermal bioavailability, it is therefore deemed not scientifically justified to do an additional animal study for acute dermal toxic effects.
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
