4-(4-isopropoxyphenylsulfonyl)phenol

Repeated dose toxicity: dermal

Administrative data

Endpoint:

sub-chronic toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
Performance of a repeated dose test for toxicity by the dermal route is scientifically not justified. REACh Regulation (EC) No 1907/2006, Annex IX, Sect. 8.6.2, Col. 2, states as follows: “8.6.2: Testing by the dermal route is appropriate if: - (1) skin contact in production and/or use is likely; and - (2) the physicochemical properties suggest a significant rate of absorption through the skin; and - (3) one of the following conditions is met: - toxicity is observed in the acute dermal toxicity test at lower doses than in the oral toxicity test, or - systemic effects or other evidence of absorption is observed in skin and/or eye irritation studies, or - significant dermal toxicity or dermal penetration is recognised for structurally-related substances.” Use of formulated D-8 is unlikely to result in exposure via the dermal route. During use D-8 is included in three-dimensional matrices of resinous material and completely retained. Therefore, exposure via the dermal route is practically negligible. For more details on exposure assessment see the risk assessment report in section 13. Further, physico-chemical properties of D-8 suggest no evidence of a significant absorption by the dermal route. The acute dermal toxicity testing showed no local or systemic toxicity. Neither skin nor dermal irritation tests showed signs of systemic effects by absorption through skin or mucous membranes. A 90 day oral repeated dose toxicity study in rats showed a NOEL of 50 mg/kg bw/day. Acute oral administration at dose levels up to 5000 mg/kg bw/day (limit dose) did not reveal any toxicological effects. In summary, based on exposure assessment and available toxicity tests, further repeated dose testing of D-8 by the dermal route is scientifically not justified.