Registration Dossier
Registration Dossier
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EC number: 814-835-0 | CAS number: 1310672-91-3
Endpoint summary
Administrative data
Description of key information
Supporting data on repeated dose toxicity are available for CD08467 and for the read-across partner CD08479.
In a repeated dose toxicity study, the test item CD08467 (purity 98.3%LC) was applied orally by gavage to Göttingen® minipigs (1/sex/dose) at dose levels of 0, 300, 600 and 1200 mg/kg bw/day for 14 days. At 1200 mg/kg/day, notable effects on physiological parameters, such as reduced body weight and food consumption, were noticed. These signs were associated with microscopic findings in the female of high-dose level group such as multifocal ulcers/erosions in the cardia region of the stomach and slight but diffuse hepatocytes vacuolation of the liver. These microscopic findings associated with effects on physiological parameters could be related to the high dose level. Since this study has methodological limitations (1 animal per sex per dose used, 14-day exposure, study not performed under the scope of GLP), it cannot be used to dertermine a NOAEL and has to be regarded as supportive information for repeated dose toxicity.
In a 14-day repeated dose toxicity study, the test item CD08479 (purity: 98.1%) was applied orally by gavage to Wistar rats (6/sex/dose) at dose levels of 0, 90, 260 or 420 mg/kg bw/day in carboxymethyl cellulose (CMC) 0.1% / PG 4% / 0.2% Poloxamer 124 for 14 consecutive days. In this study, no adverse effects were observed up to the highest dose.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
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.
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