Registration Dossier
Registration Dossier
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EC number: 219-708-8 | CAS number: 2503-73-3
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Remarks:
- Assessment of available information
- Type of information:
- other: Assessment of Toxicokinetic Behaviour
- Adequacy of study:
- key study
- Study period:
- January-May 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
- Objective of study:
- toxicokinetics
- Qualifier:
- no guideline required
- GLP compliance:
- 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 Blue 78 did not penetrate into the organism through the skin after single application.The test compound is considered to be non-irritating to the eye of rabbit.The target organ of systemic toxicity after repeated oral administration in organism of males seems to be kidneys. The test substance is absorbed through the blood circulation and systemic effect occurs. But the extent of this effect is very small and it is manifested in animals of male sex only. 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.
Reference
Description of key information
Evaluation of toxicokinetics of the test substance Direct Blue 78 -CAS No.2503-73-3 was performed according to the demand given in part 8.8.1 of Annex VIII to the Directive (EC) No. 1907/2006 (REACH): “Assessment of the toxicokinetic behavior of the substance to the extent that could be derived from the relevant available 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 asnon-toxic (after single oral application).
Direct Blue 78 did not penetrate into the organism through the skin after single application.
The test compound is considered to be non-irritating to the eye of rabbit.
The target organ of systemic toxicity after repeated oral administrationin organism of males seems to be kidneys.The test substance is absorbed through the blood circulation and systemic effect occurs. But the extent of this effect is very small and it is manifested in animals of male sex only. Results recorded during the reproduction part of study with repeated oral administration showed that the test substancedid not penetrate into the testesand throughthe placental barrier.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
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.
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