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Administrative data

Description of key information

The test material was determined to have a NOAEL of 1000 mg/kg/day in a 28 day repeat dose study performed in accordance with OECD 410.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

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 adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
The study was conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. It was assigned a reliability score of 1 in accordance with the criteria for assessing data quality as outlined in Klimisch (1997).

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The dermal repeat dose toxicity of the test material was determined following a methodology equivalent to standardised guideline OECD 410. Groups of fifteen male and fifteen female rats were dermally administered 20% w/w, 50% w/w or 100% test material in mineral oil for a period of 4 weeks. Animals were treated for 6 hours per day, six times a week during week 1, five time per week during weeks 2 and 3 and four times a week during week 4. An additional group of fifteen males and fifteen females were treated with mineral oil alone and served as controls. Clinical observations, bodyweights and skin irritation parameters were measured throughout the study. At the end of the scheduled period, the animals were killed and subjected to an examination post mortem. Cardiac blood samples were taken for clinical pathology, selected organs were weighed and specified tissues were taken for subsequent histopathology examination. Under the conditions of the study, subacute dermal treatment of male and female rats with test material did not cause any mortality or any signs of toxicity. Mild skin irritation appeared in both sexes during the first week of the study, but subsided thereafter. The statistically significant changes in mean serum calcium levels, serum phosphorus levels, blood urea nitrogen , blood urea nitrogen/creatinine ratios, left ovary weight, left ovary/body weight ratio and brain weight were not considered biologically significant. No other significant changes occurred that could be attributed to treatment with the test material. The No Observed Adverse Effect Level was subsequently determined to be 1000 mg/kg bw/day.


Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
Only one study is available.

Justification for classification or non-classification

In accordance with criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification for specific organ toxicity, repeated dose. The effects observed in the available study are not considered to be toxicologically significant and do not indicate any signs of organ dysfunction.