Registration Dossier
Registration Dossier
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EC number: 229-390-2 | CAS number: 6505-30-2
Endpoint summary
Administrative data
Description of key information
In an acute oral toxicity study the test substance was applied as a single dose of 2500 mg/kg bw to 10 male Wistar rats per gavage. The animals were inspected for mortality and signs of intoxication during the following 14-day observation period. A dose of 2500 mg/kg body weight was tolerated without signs of poisoning by all animals. The discriminating dose was 2500 mg/kg bw.
No acute inhalation or dermal toxicity studies are available.
According to Commission Regulation (EU) 2016/863 of May 2016 acute toxicity testing by the dermal route (Annex VII, point 8.5.3., column 2) ‘does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure’. The registered substance conforms with the requirements given above. Therefore, it can be concluded for acute dermal toxicity that the available information is conclusive for non-classification.
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- 10 male rats received a single dose of Acilanbrillantblau FFR 200% = Special Brilliant Blue FFR in lutrol by gavage. The rats were observed during 14 days for clinical signs and mortality.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- Acilanbrillantblau FFR 200% = Special Brilliant Blue FFR
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Doses:
- 2500 mg/kg bw.
- No. of animals per sex per dose:
- 10 male rats/dose
- Control animals:
- no
- Statistics:
- Probit-Analysis (Fink und Hund, Arzneimittelforsch. 15, 624 (1965)
- Key result
- Sex:
- male
- Dose descriptor:
- discriminating dose
- Effect level:
- 2 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None of the animals died.
- Clinical signs:
- other: No signs
- Gross pathology:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- None of the animals died. The discriminating dose was 2500 mg/kg bw (rat, male).
- Executive summary:
A single dose of 2500 mg/kg bw of the test substance was applied to 10 male Wistar rats per gavage. The animals were inspected fpor mortality and signs of intoxication during the following 14-day observation period. A dose of 2500 mg/kg body weight was tolerated without signs of poisoning by all animals. The discriminating dose was 2500 mg/kg bw.
Reference
Based on technical reasons, the highest applied dose was 2500 mg/kg bw.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 500 mg/kg bw
- Quality of whole database:
- Scientifically acceptable and well documented.
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
Justification for classification or non-classification
In an acute oral toxicity study the discriminating dose for male rats was 2500 mg/kg body weight.
According to Commission Regulation (EU) 2016/863 of May 2016 acute toxicity testing by the dermal route (Annex VII, point 8.5.3., column 2) ‘does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure’. The registered substance conforms with the requirements given above. Therefore, it can be concluded for acute dermal toxicity that the available information is conclusive for non-classification.
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified for acute oral and dermal toxicity.
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.
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