Registration Dossier

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Administrative data

Description of key information

The NOAEL for systemic effects was 75 mg/kg bw (the highest dose level used) in a repeated dose toxicity/screening reprotoxicity study according to OECD guideline No. 422. 

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

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

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

The dossier does not currently have a subchronic (90-day) toxicity study. Therefore, there is a data gap for this endpoint.

The results of the OECD 422 combined repeated dose/reproduction and developmental toxicity screening study indicate test substance-related findings at 75 and 200 mg/kg bw/day relating to mortality/morbidity, adrenal gland weights, neutrophil counts, macroscopic and/or microscopic findings of the stomach, adrenal cortex and thymus were attributed to the irritative properties of the test substance and corresponding stress, rather than systemic toxicity. Thus, the NOAEL for local irritation was 25 mg/kg bw/day.

Under the conditions of this screening study, based on test substance-related lower mean body weight gains during the overall study period for the 200 mg/kg bw/day males as well as a lower mean body weight on day 27, the NOAEL for systemic toxicity was considered to be 75 mg/kg bw/day.


Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
The study used for this end-point is an OECD 422 study with a supporting substance (read-across). The study has been conducted under GLP. The substance used for read-across is a structural analogue with a similar functional group and comparable phys-chem properties as the substance to be registered.

Justification for classification or non-classification

Based on the information obtained in a repeated dose toxicity/screening reprotoxicity study according to OECD guideline No. 422, the substance does not need to be classified for repeated dose toxicity, according to the Regulation EC 1272/2008 and the Directive 67/584/EEC.