Registration Dossier
Registration Dossier
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EC number: 250-792-9 | CAS number: 31765-95-4
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Type of information:
- other: assessment from available information
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- assessment from available information
- GLP compliance:
- no
- Radiolabelling:
- no
- Conclusions:
- According to current valid guidance the test substance with the result of LD50 in acute oral test higher than 2000 mg/kg is considered as non-toxic (after single oral application). Direct Black 112 did not penetrate into the organism through the skin after single application.The test substance is considered to be non-irritating to the eye and skin of rabbit. The test substance was shown to be a contact allergen in guinea pigs.The systemic toxicity after repeated oral administration of the test substance was observed. Microscopic changes in organs of digestive system, lymph nodes and kidneys, changed biochemical and haematological parameters were recorded.Test substance did not influenced reproduction parameters of males and females. Development of pups was not influenced by the test substance administration. Results recorded during the reproduction part of study with repeated oral administration showed that the test substance did not penetrate into the testes and through the placental barrier.No data about metabolism, distribution and excretion of the test substance were found.
Reference
Description of key information
According to current valid guidance the test substance with the result of LD50 in acute oral test higher than 2000 mg/kg is considered as non-toxic (after single oral application). Direct Black 112 did not penetrate into the organism through the skin after single application.
The test substance is considered to be non-irritating to the eye and skin of rabbit.
The test substance was shown to be a contact allergen in guinea pigs.
The systemic toxicity after repeated oral administration of the test substance was observed. Microscopical changes in organs of digestive system, lymph nodes and kidneys, changed biochemical and haematological parameters were recorded.
Test substance did not influenced reproduction parameters of males and females. Development of pups was not influenced by the test substance administration. Results recorded during the reproduction part of study with repeated oral administration showed that the test substance did not penetrate into the testes and through the placental barrier.
No data about metabolism, distribution and excretion of the test substance were found.
Key value for chemical safety assessment
Additional information
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.
