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Administrative data

Description of key information

Two studies are available for the repeated dose oral toxicity endpoint:
A Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (28 days).
A Toxicity study by oral gavage administration to CD rats for 13 weeks followed by a 4 week recovery period

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat

Additional information

Information regarding repeated dose toxicity of Fyrolflex SOL-DP exists for the oral route via a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test of E-AF098T in rats.

In the ‘Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening test’, rats were exposed to daily administration of the test substance for 14 days prior mating and for additional 28 days during mating and pregnancy. No treatment- related deaths or adverse clinical effects of toxicity were observed during this screening study. No adverse treatment- related alteration in food consumption, body weights, organ weights, clinical chemistry, clinical pathology, motor activity or functional observational battery were noted. No treatment-related gross lesions or microscopic findings were noted. Therefore, the no-observed-adverse-effect level (NOAEL) for the product in rats is greater than 1000 mg/kg (highest dose tested).

The oral administration of SOL-DP to Sprague-Dawley (Crl:CD(SD)) rats at doses up to 1000 mg/kg/day for 13-weeks was well tolerated and did not result in any toxicologically significant change. Consequently, the no observed adverse effect level (NOAEL) in this study was considered to be 1000 mg/kg/day (highest dose tested).

Toxicity thorough dermal route of repeated exposure is not expected based on previous dermal tests. In the acute dermal toxicity test, Fyrolflex SOL-DP did not show any signs of local or systemic toxicity when dosed at 5000mg/Kg. The substance was not irritant to the skin, didn't induce eye irritation and didn't cause any allergic reaction by contact with the skin. In addition, no systemic toxicity was observed in the repeated dose toxicity test according to OECD 422. Hence, we believe that toxicity after repeated dermal exposure is not likely to occur.

The toxicity of Fyrolflex Sol-DP via the inhalation route was tested

Justification for classification or non-classification

Fyrolflex SOL-DP did not show any potential for subchronic effects in the available studies.

Therefore, it can be concluded that the substance does not need to be classified according to the EEC criteria for classification and labelling for Dangerous Substances and Preparations (67/548/EEC) and the CLP Regulation (EC No 1272/2008).