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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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