Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
500 mg/kg bw/day
Study duration:
subacute
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEC
49.5 mg/m³
Study duration:
subchronic
Species:
rat

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEC
49.5 mg/m³
Study duration:
subchronic
Species:
rat

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LOAEL
250 mg/kg bw/day
Study duration:
subacute
Species:
rabbit

Additional information

Adverse effect observed


Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
A NOAEL of 500 mg/kg bw/day was identified in this study.

Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
The test article elicted a range of effects in the lung; accumulation of intraalveolar macrophages, hyperplasia/hypertophy of the bronchiole epithelium. While these effects were also seen in control animals, there was a dose response in mid and high dose treated animals which was considered treatment related. A NOAEL of 49.5 mg/m³ was identified.

Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
The test article elicted a range of effects in the lung; accumulation of intraalveolar macrophages, hyperplasia/hypertophy of the bronchiole epithelium. While these effects were also seen in control animals, there was a dose response in mid and high dose treated animals which was considered treatment related. A NOAEL of 49.5 mg/m³ was identified.

Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
Toxicity occurred at all doses tested, therefore a NOAEL has not been identified. an arbitary LOAEL of 250 mg/kg bw has been identified, based on effects at the lowest dose.

Justification for classification or non-classification

Adverse effect observed