Registration Dossier
Registration Dossier
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EC number: 251-410-3 | CAS number: 33229-34-4
Endpoint summary
Administrative data
Description of key information
The test item, HC Blue No 2, when administered daily by gavage to Sprague-Dawley rats at the dose level of 100, 300 or 1000 mg/kg bw/day for 13 weeks was well absorbed and caused purple colouration of urine and, as a consequence, of extremities and excessive salivation in all the treated animals. At 1000 mg/kg bw/day, higher absolute and relative liver and kidney weights were observed in both sexes at the end of the dosing period and the recovery period (except for kidneys in males) while no changes were noted on hematology or biochemistry parameters. Only relative liver increases in females given 1000 mg/kg bw/day were considered to be test item related adverse effects. No treatment related findings were noted at histopathological examination. After a 4 week treatment free period, coloured urine and excessive salivation were no longer observed while the slight increase in liver weights were still observed in females given 1000 mg/kg bw/day. Under the experimental conditions of the study the NOAEL of the test item was considered to be 300 mg/kg bw/day.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
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.
