Registration Dossier

Diss Factsheets

Administrative data

Description of key information

NOAEL = 1000 mg/kg bw/day upon 28 days exposure.

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:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
The complete read across justification is detailed in section 13. Test substance is an isomer of the substance under registration; structural difference is not expected to significantly impact the toxicity potential. Source study has reliability 4: only limited information available from a migrated NONS file, as per Article 25(3) request.
Principles of method if other than guideline:
No information on the method is available.
GLP compliance:
not specified
Duration of treatment / exposure:
28 days
Dose descriptor:
NOAEL
Effect level:
ca. 1 000 mg/kg bw/day (nominal)
Based on:
not specified
Sex:
not specified
Basis for effect level:
other: not specified
Critical effects observed:
not specified
Conclusions:
NOAEL = ca. 1000 mg/kg bw/day
Executive summary:

Method

No information on the method is available. Information derived from migrated NONS file, as per Article 25(3) request, permission to refer granted by ECHA.

 

Results

NOAEL = ca. 1000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute

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

Justification for classification or non-classification