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Registration Dossier
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EC number: 418-280-1 | CAS number: 18600-59-4 CYASORB(R) UV-3638 LIGHT STABILISER
Endpoint summary
Administrative data
Description of key information
28-day Repeated dose toxicity
oral：NOAEL is 15 mg/kg bw/day (EU method B.7)
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 15 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
Repeated dose oral toxicity
The repeated dose toxicity was evaluated in a well conducted GLP and EU method B.7 study with Sprague-Dawley rats. 10 rats per group (5 per sex) were gavaged with Chiguard 380/Chiguard 380W at dose of 0 mg/kg bw/day, 15 mg/kg bw/day, 150 mg/kg bw/day and 1000 mg/kg bw/day for 7 days per weeks. The exposure duration is 28 days.
There were no clinical signs or mortalities, nor any adverse treatment-related changes in body weight (gain), food and water consumptions. No adverse treatment-related changes in haematology or biochemistry. Liver weight (adjusted for body weight) was statistically significantly increased (dose-dependently) in male rats given 150 and 1000 mg/kg bw/day. In the 1000 mg/kg group the increased liver weight was accompanied by an increased incidence of congestion (incidences were 1/5 and 4/5 in males of the control group and the 1000 mg/kg group, respectively.)
Microscopic examination of the testes reveled vacuolation of the Sertoli cells of some tubules in 0/5, 1/5, 2/5 and 3/ 5 males of the groups given 0, 15, 150 and 1000 mg/kg bw, resp.
NOAEL of 15mg/kg bw/day was established in the study.
Repeated dose dermal toxicity
No relevant information is available.
Repeated dose inhalation toxicity
No relevant information is available.
Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: liver
Justification for classification or non-classification
Based on the available information in the dossier, the substance Chiguard 380/Chiguard 380W (CAS# 18600-59-4) needs no classification for specific target organ toxicity after repeated exposure when considering the criteria outlined in Annex I of 1272/2008/EC.
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