2-hydroxy-1-[4-[4-(2-hydroxy-2-methylpropanoyl)phenoxy]phenyl]-2-methylpropan-1-one

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Toxic effect type:

dose-dependent

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

5 mg/kg bw/day

Study duration:

subacute

Experimental exposure time per week (hours/week):

168

Species:

rat

Quality of whole database:

The information requirement for this tonnage band is sufficiently met with the available data.

Endpoint conclusion:

no study available

Endpoint conclusion:

no study available

A study was conducted to determine the repeated dose oral toxicity of the test substance according to OECD Guideline 407 and EU Method B.7, in compliance with GLP. Groups of 5 male and female Hsd rats were administered 0, 5, 50 and 150 mg/kg bw/day of test substance by oral gavage for 28 days. There were no treatment-related changes at 5 mg/kg bw/day. No severe treatment-related clinical signs were notede at any dose. Individual haematology deviations were observed but considered not biologically relevant. No significant changes were observed in urine parameters. In the high dose group, feed consumption and body weight were affected in males. Treatment-related histopathological findings were observed in the adrenal gland, liver, lung and spleen, at 50 and 150 mg/kg bw. After 14 days recovery period for the high dose group, liver changes were fully reversible and adrenal gland, lung and spleen changes had almost reversed. Under the study conditions, the rat 28 d NOEL for systemic effects was considered to be 5 mg/kg bw/day (Bioservice, 2007). 

 

Based on the result of a repeated dose oral toxicity study (OECD Guideline 407), the test substance does not warrant classification for this endpoint according to EU CLP criteria (Regulation 1272/2008/ EC).