Registration Dossier
Registration Dossier
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EC number: 402-860-6 | CAS number: 110553-27-0 CG 25-1320; IRGANOX 1520; TK 12229/1
Endpoint summary
Administrative data
Description of key information
Summary of 28-day repeat dose study
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 250 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
No clinical symptoms related to the administration of the test article and no signs of systemic toxicity were observed during the 28-day study. The findings in treated groups were unremarkable and comparable to those of the controls. The investigations revealed a minimal higher activity of alkaline phosphatase in the male of group 4 (250 mg/Kg) and male and females of the high dose group (1000 mg/Kg). A trend to slightly increased liver weights was observed in treated males group 4 and 5 (250 + 1000 mg/Kg) and in females group 5. Macroscopical and microscopical examination revealed no changes which could be attributed to effects of the test compound.
No toxic effect level: 50 mg/Kg body weight
Due to this fact, and the fact that exposure to the test substance is expected to be very low, based on its granular form and its identified uses, further animal testing such as a 90-day sub-chronic toxicity study is considered not to be justified.
The following information is taken into account for any hazard / risk assessment:
Assessment of subacute exposure by oral route is discussed below.
Value used for CSA (route: oral):
NOAEL: 250 mg/kg bw/day (subacute; rat)
NOEL: 50 mg/kg bw/day (subacute:rat)
Justification for classification or non-classification
The above studies have all been ranked reliability 1 according to the Klimish et al system. This ranking was deemed appropriate because the studies were all conducted to GLP in compliance with recognised guidelines. The majority of the information has been provided from a migrated nons file referring to studies which are more than 12 years old, with the permission of ECHA.
The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for acute effects is therefore required.
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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