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Administrative data

Description of key information

NOAEL systemic toxicity: 1000 mg/kg bw (highest dose tested, OECD 407, BASF SE 2010)
NOAEL local effects: 300 mg/kg bw (OECD 407, BASF SE, 2010)

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat

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

The test substance was administered for 4 weeks daily by gavage to male and female Wistar rats at dose levels of 0, 100, 300 and 1000 mg/kg bw/d (test groups 0-3) according to OECD 407 guideline (BASF SE, 2010). Drinking water was used as vehicle control and vehicle for the test substance.

Regarding clinical examinations, signs of general systemic toxicity were not observed up to a dose level of 1000 mg/kg bw/d.

Salivation was seen after dosing in all rats of test group 3 (1000 mg/kg bw/d), in all male and 3 female animals of test group 2 (300 mg/kg bw/d) and in 1 male animal of test group 1 (100 mg/kg bw/d). From the temporary, short appearance immediately after dosing it is most likely, that this finding was induced by a bad taste of the test substance or local affection of the upper digestive tract. This finding was not considered to be an adverse and toxicologically relevant effect.

Concerning clinical pathology no treatment-related, adverse effects were observed up to a dose of 1000 mg/kg bw/d.

Regarding pathology, the target organ was the forestomach. In 3 different male and 1 female animal of test group 3 (1000 mg/kg bw/d) a focal squamous hyperplasia (1 male), an erosion or ulcer occurred in the region of margo plicatus (1 male and 1 female) and a minimal focal inflammation in the region of margo plicatus (1 male) were noted. All these findings were related to treatment and were considered to be adverse. Again, these findings were most likely related to the irritating potential as the test substance was directly administered into the forestomach by gavage with the consequence of a local irritation.

All further findings occurred either singly or were biologically equally distributed over the control group 0 and the treatment groups 1-3 (100, 300 and 1000 mg/kg bw/d). They were considered to be incidental or spontaneous in origin and without any relation to treatment.

The NOAEL for systemic toxicity was 1000 mg/kg bw., the NOAEL for local effects in the forestomach was 300 mg/kg bw.

Justification for classification or non-classification

Besides local irritation in the forestomach, no other effects relevant to human health were observed. Therefore no classification and labeling is required according to 67/548/EWG and 1272/2008/EG (CLP).