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Administrative data

Description of key information

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
200 mg/kg bw/day
Study duration:
chronic
Species:
rat
System:
other: Impaired grooming activity and retarded body weight at 1000 mg/kg

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Based on read across a chronic feeding study is available for the assessment of paraffin oils, sulfochlorinated, saponified. This study similar to OECD TG 452, but conducted at a time before the guideline was available, investigated the chronic toxicity of the read across substance

(test material was as aqueous slurry with 60 % active ingredient; all concentrations quoted here are in terms of the active ingredient). For that purpose groups of 20 male and 20 female rats were fed diets containing 0.08, 0.4 and 2.0 % (w/w) test substance for 52 weeks (approximate doses 40, 200 and 1000 mg/kg bw and day). A similar sized group received plain diet and served as control. For each dose additional 10 male and 10 female sentinel animals were used for interim pathological examination (terminated after 26 weeks of treatment).

As result it was demonstrated, that concentrations of the test substance in the diet up to 0.4 % (w/w; approx. 200 mg/kg bw) were tolerated by the animals without any significant effect. Even at the highest dose level of 2 % (w/w; approx. 1000 mg/kg) only unspecific effects not accompanied by any functional or structural changes have been observed (i.e. impaired grooming activity and retarded body weight gain). No NOAEL was stated in the report, but based on the available data a NOAEL of 200 mg/kg bw (corresponding to diet with 0.4 % ) can be defined.

Justification for classification or non-classification

According to Regulation (EC) No 1272/2008, Annex I, no classification is required for repeated dose toxicity.