Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
repeated dose toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

Data source

Materials and methods

Test material

Constituent 1
Reference substance name:
-
EC Number:
451-530-8
EC Name:
-
Cas Number:
736150-63-3
Molecular formula:
Not applicable
IUPAC Name:
Not allocated

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
It is assessed that dermal absorption of TS-ED 532 is negligible and consequently that the possibility of systemic effects via dermal absorption are negligible. There was no evidence of dermal absorption in an acute dermal toxicity test in rats at 2000 mg/kg and in a dermal irritation test. The water solubility of TS-ED 532 is very low and the n-octanol/water partition coefficient is high.
Executive summary:

The repeated dose dermal toxicity study of TS-ED 532 has not been performed in accordance with annex IX, column 2 (8.6.2). There was no evidence of dermal absorption in an acute dermal toxicity test in rats with 2000 mg/kg and in a dermal irritation test. The water solubility is very low (0.06-0.09 mg/l at 20 °C), and the n-octanol-water partition coefficient is high (Log Pow: 6.42). Thus, the potential for dermal absorption is considered to be low . Consequently possible systemic effects via dermal absorption are negligible.

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