Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

A 90-day repeated dose oral toxicity study is available for the submission substance.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
275 mg/kg bw/day
Study duration:
chronic
Species:
rat
Quality of whole database:
A modern, guideline- and GLP-compliant 90-day rat study is available for the submission substance.

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 90 -day repeated dose oral toxicity study performed with the submission substance (Longobardi, 2017) reports a NOAEL of 275 mg/kg bw/d, based on findings (mortality, clinical signs, changes in haematology and clinical chemistry parameters and increased liver weight at the highest dose level of 750 mg/kg bw/d. A slight reversible increase in liver weight without pathological correlates and minor fluctuations in clinical chemistry parameters seen at 275 mg/kg bw/d were not considered to represent an adverse effect.

Justification for classification or non-classification

No classification is proposed: relevant data are not available