Registration Dossier
Registration Dossier
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EC number: 415-430-8 | CAS number: 86403-32-9 CYASORB UV-3853 LIGHT STABILIZER; DASTIB 845; SANDUVOR 845
Endpoint summary
Administrative data
Description of key information
One subacute and one 70 day oral toxicity studies for this substance indicate that it has a low potential for adverse systemic effects from repeated dose exposures. There is a local effect on the upper gastrointestinal tract, likely due to irritation.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 40 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
Two guideline studies were undertaken on this substance administered orally to rats at doses between 40 and 1000 mg/kg bw/d for 28 to 70 days. In the 28 day study, lesions were present in the duodenum in animals dosed at 200 mg/kg bw/d and higher, which resolved after 14 days of recovery; no similar lesions were noted in the second, more recent 2 generation study. The systemic NOAEL is over 250 mg/kg bw/d, and may be higher than 1000 mg/kg bw/d. The local NOAEL for repeated dose exposure is 40 mg/kg bw/d, based on effects (presumably from local irritation) in the proximal gastrointestinal tract.
There is no information available for repeated dose exposure by the dermal or inhalation routes, but these routes are not expected to convey a risk due to limited exposure (dermal protection is recommended to minimize exposure to the skin, and the waxy nature of the substance does not promote formation of inhalable particles).
The following information is taken into account for any hazard / risk assessment:
Two repeated dose oral toxicity studies for this substance indicate that it has a low potential for adverse systemic effects from repeated dose exposures. There is a local effect on the upper gastrointestinal tract, likely due to irritation.
Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: duodenum
Justification for classification or non-classification
There is no data to suggest the presence of specific target organ toxicity after repeated-dose oral exposure to this substance. No classification is required.
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