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Administrative data

Description of key information

Oral:

In an in vivo repeated dose toxicity study in rats according to OECD guideline 407 (BASF SE, 2010), a NOAEL of > 1000 mg/kg bw/day was determined.

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
Quality of whole database:
GLP and guideline compliant study report.

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

Repeated dose toxicity: oral

In a subacute repeated dose toxicity study according to the OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents), the test substance was administered in feed to male and female Wistar rats at dose levels of 0 ppm (test group 0), 1500 ppm (test group 1), 5000 ppm (test group 2) and 15000 ppm (test group 3) over a period of 4 weeks (BASF SE, 2010). Control and test group 3 (15000 ppm) consisted of 10 animals per sex each, whereas test groups 1 (1500 ppm) and 2 (5000 ppm) consisted of 5 animals per sex each. After 4 weeks of treatment 5 animals per sex of all test groups were sacrificed (main groups). The remaining 5 animals per sex of control and test group 3 (15000 ppm) were maintained for another 14 days without administration of the test substance (recovery groups).

Food consumption and body weight were determined weekly. The animals were examined for signs of toxicity and mortality at least once a day. Detailed clinical examinations in an open field were conducted prior to the start of the administration period and weekly thereafter. Additionally, a functional observational battery (FOB) as well as measurement of motor activity (MA) was carried out at the end of the study. Clinicochemical and hematological examinations as well as urinalyses were performed towards the end of the administration period. An additional blood sampling in male animals only was performed at the end of the recovery period. All animals were assessed by gross pathology, followed by histopathological examinations. The following test substance-related, relevant findings were noted:

No treatment-related adverse effects were observed. A yellow discoloration in all animals of both sexes of test group 3 (15000 ppm) was observed, i.e. faeces and urine during the entire study period and fur from day 22 onwards, of test group 2 (5000 ppm), i.e. faeces and urine during the entire study period, and of test group 1 (1000 ppm), i.e. urine from day 7 onwards. Fur contamination occurs as a result of both the coloured feces and the coloured feed.

During the recovery period, the discoloration of faeces, urine and fur disappeared in all animals of test group 3 (15000 ppm; study day 31). This finding was clearly attributable to the ingestion and excretion of the test substance as the test substance is coloured. Its physical (tinctorial) properties do not represent a toxicologically relevant finding or adverse effect.

A NOAEL of > 15000 ppm (♂: > 1160 mg/kg bw/d; ♀: 1026 mg/kg bw/d) was determined.

 

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The NOAEL was greater than 1000 mg/kg bw. As a result the substance is not considered to be classified for repeated dose oral toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.