Registration Dossier

Diss Factsheets

Administrative data

Description of key information

In a subacute repeated dose oral toxicity study with Sprague-Dawley rats a NOEL of >= 1000 mg/kg for the test substance was observed (MHLW 10-1630, 2000).

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

A 28-day repeated dose oral toxicity study with subsequent 14-day recovery test of the test substance in rats has been conducted (MHLW 10-1630, 2000). Male and female Sprague-Dawley rats were orally (gavage) administered with the test substance in corn oil at doses of 100, 300 and 1000 mg/kg. A control group receiving only corn oil was also included in the test. For both males and females, 10 animals each were used in the control group and 1000 mg/kg group which are used in the recovery test, and 5 animals each were used in the other groups.

As a result, in the groups to which the test substance was administered, feces in same orange color as the test substance were observed continuously from day 2 of administration to the end of the administration period, but any other changes in general condition which are attributable to the test substance administered were not observed. Furthermore, in terms of body weight, food consumption, urine examination, hematological examination, biochemical examination, and pathological examination including organ weights, any changes which are assumed to have been caused by the test substance administered were not observed.

Under the conditions of this test, no changes in the organism functions and morphologies of the test animals were observed. Accordingly, the NOEL for the test substance is >= 1000 mg/kg for both males and females.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. The NOEL was 1000 mg/kg bw. There were consequently no significant toxic effects at doses of less than 300 mg/kg bw upon subacute oral exposure in rats. As a result the substance is not classified for repeated dose toxicity under Regulation (EC) No. 1272/2008,as amended for the seventh time in Regulation (EC) No 2015/1221.