Registration Dossier

Administrative data

Description of key information

Read across to OECD 422: parental NOAEL (56 -66 days, oral, rat) = 1000 mg/kg bw/day (highest dose tested)

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
For this endpoint a one-to-one read across was performed to a chemical similar compound of the same chemical class with a comparable phys. chem. profile and similar response in biological assays. The relevant study was performed according to GLP and the methods applied are fully compliant with OECD Guideline 422. A read across justification is provided in the attached document (Chapter 13).
GLP compliance:
yes (incl. certificate)
Limit test:
no
Key result
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: absence of adverse effects
Key result
Critical effects observed:
no
Conclusions:
For this endpoint a one-to-one read across was performed to a chemical similar compound of the same chemical class with a comparable phys. chem. profile and similar response in biological assays. The relevant study was performed according to GLP and the methods applied are fully compliant with OECD Guideline 422. A read across justification is provided in the attached document (Chapter 13). The NOAEL of this study is 1000 mg/kg bw/day.
Executive summary:

For this endpoint a one-to-one read across was performed to a chemical similar compound of the same chemical class with a comparable phys. chem. profile and similar response in biological assays. The relevant study was performed according to GLP and the methods applied are fully compliant with OECD Guideline 422. A read across justification is provided in the attached document (Chapter 13). The NOAEL of this study is 1000 mg/kg bw/day.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
GLP and Guideline conform study

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 systemic toxicity of the source substance was investigated in a experimental study according to OECD test guideline 422 under GLP-conditions. The substance, solved in distilled water, was administered to Wistar rats of both sexes by oral gavage in doses of 100, 300 and 1000 mg/kg bw daily for 56 to 66 days (depending on mating effectiveness). In this study, no treatment-related toxicological effects were observed and the NOAEL was 1000 mg/kg bw/day, i.e. the highest dose tested. Therefore, the substance was considered to be not systemically toxic in this study.

Justification for classification or non-classification

Based on the available data, the substance is not considered to be classified for repeated dose toxicity after oral exposure according to the EU Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures, as amended for the 10th time in Regulation (EU) No 2017/776.