4-(4-isopropoxyphenylsulfonyl)phenol

Repeated dose toxicity: inhalation

Administrative data

Endpoint:

sub-chronic toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
The performance of a repeated dose test for toxicity by inhalation 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 inhalation route is appropriate if exposure on humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of inhalable size.” During use D-8 is included in three-dimensional matrices of resinous material and completely retained. Therefore, exposure to aerosols, particles or droplets of inhalable size is unlikely and inhalation practically negligible. For more details on exposure assessment see the risk assessment report in section 13. Further, physico-chemical properties of D-8, including particle size determination, suggest no evidence of a significant absorption by inhalation. The substance is practically non-volatile, with vapour pressure determined below 1.0E-05 Pa at 27 °C and the mean volumetric diameter of particles was determined to be 5.12 µm. Therefore, availability of D-8 in air and the formation of inhalable particles are not very likely. The acute inhalation 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 revealed a NOEL of 50 mg/kg bw/day. In summary, based on exposure assessment and available toxicity tests, further repeated dose testing of D-8 by inhalation is scientifically not justified.