Registration Dossier
Registration Dossier
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EC number: 288-422-3 | CAS number: 85721-12-6
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
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
Based on data reported on Colipa report for
similar substance, some test are available for repeated dose toxicity.
The subacute studies were used to assess the acute oral toxicity
endpoint.
There is a chronic study available on similar substance performed on
dogs.
The 2-year oral toxicity study, diets containing 0.37, 1.39 and 5.19 %
of the tested substance respectively, were fed to groups of four dogs
(two female/two male) each.
Eight animals (four per sex) were used for the concurrent control group. An interim sacrifice took place after 1 year (one animal per sex and group). Behaviour and clinical chemistry as well as macroscopic and microscopic investigations were performed. Besides some not further specified tissue effects after 1 year which were not seen after the final 2-year treatment no substance related effects were noted.
From this 2-year feeding study a NOEL of
5.19 % the tested substance in the diet can be derived which is equal to
about 1500 mg/kg bw/day (assuming a feed consumption of 250 g/day and an
average bodyweight of 8-9 kg).
Based on the absence of effects, the substance should be considered as
not toxic for repeated oral dose toxicity.
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