Registration Dossier

Administrative data

Description of key information

Based on a slight and transient increased locomotor activity observed in females treated with 300 or 1000 mg/kg/day (with no statistical significance), the NOAEL was considered to be 1000 mg/kg bw/day in females, and a NOEL was established at 1000 mg/kg bw/day in males (doses are corrected for the purity of the main constituent).
The NOAEL expressed for the substance as registered (i.e. with the residual water content necessary to the stability, and impurities) is therefore 2420 mg/kg bw/day. No target organ identified.

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
2 420 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Study in compliance with current OECD guidelines and GLP standards.

Repeated dose toxicity: inhalation - systemic effects

Link to relevant study records
Reference
Endpoint:
repeated dose toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:
Critical effects observed:
not specified
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

Link to relevant study records
Reference
Endpoint:
repeated dose toxicity: dermal
Data waiving:
other justification
Justification for data waiving:
other:
Critical effects observed:
not specified
Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Mode of Action Analysis / Human Relevance Framework

Additional information

No experimental data are currently available for the dermal and the inhalation routes.

The repeated treatment by the oral route produced a slight and transient increase in locomotor activity (not statistically significant) in females treated at 300 or 1000 mg/kg/day (dose corrected for the substance purity). No effects were observed in males.


Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
No significan adverse effects were observed at the dose 1000 mg/kg/day (dose as expressed for the main constituent), thus the NOAEL was at or above 1000 mg/kg bw/day (as expressed for the main constituent), i.e. 2420 mg/kg bw/day for the substance as registered (including the water preserving the stability)

Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
see justification in endpoint record.

Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
see justification in endpoint record.

Justification for selection of repeated dose toxicity dermal - local effects endpoint:
No local effects observed in the acute dermal toxicity study nor in the skin irritation study.

Justification for classification or non-classification

No adverse effects were observed in the 28-d study by the oral route in rats, and no target organs were identified. The NOAEL was established at 2420 mg/kg bw/day for the substance as registered described in section 1.2. No classification is triggered.