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The only aquatic toxicity test performed was toxicity to microorganisms, as no water conscentration control is required. This test lead to the conclusion that no toxicity was observed in a limit test at 100 mg/L nominal concentration of WP30.

Other tests were waived because scientifically injustified, for the following reasons:

1. WP30 solubility limit was measured to be < 0.020 µg/L (limit of detection). Therefore no valid test could be conducted with a water solubility limit that cannot be measured.

2. A weight of evidence approach allows concluding that WP30 is not absorbed in living cells, relying on following observations

a. Chronic toxicity studies with mammals

a.1.Combined repeated dose and reproduction / developmental screening (oral: gavage) on WP30

This validity 1 study concluded to aNOEL: > 1000 mg/kg bw/day (actual dose received) (male/female) based on test material (No effect observed) after ca. 50 days.

b. Toxicokinetic studies with mammals

b.1.Combined repeated dose and reproduction / developmental screening (oral: gavage) on WP30 : ADME results

WP30 absorption was checked. No significant systemic exposure to the test item was measured throughout 5 weeks, up to 1000 mg/kg/d.

Therefore no bioaccumulation potential was observed based on these study results.

 

b.2. In vitro skin penetration of WP30 (Human skin)

The mean absorption of applied WP30 on Human skin samples was 0.17 +/- 0.32 % (2 SD) according to SCCS/1358/10 guidance. This means that there is no WP30 absorption through Human skin.

 

b.3.In vitro skin penetration of WP30 (altered Human skin) (OECD 428)

In vitro absorption through Human skin has been determined according to OECD guidelie 428, on untreated skin, irradiated (UVA and UVB) skin, and tape-stripped and irradiated skin. Absorption was found to be negligible in all conditions.

 

b.4 Summary

Evidence of lack of absorption of WP30 has been shown in several excised skin permeation models, and mammalian toxicity studies performed, up to 5 weeks daily repeated ingestion.

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