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Description of key information

In a GLP compliant OECD 422 combined repeated dose toxicity study with the reproductive/developmental screening test in Wistar rats the oral administration of the read-across substance by oral gavage to male and female Wistar rats did not result in signs of systemic toxicity up to a dose level of 1000 mg/kg bw/d.

The no observed adverse effect level (NOAEL) for general systemic toxicity was 1000 mg/kg bw/d for males and females.

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
Read-across from the alternative salt form of the substance is justified in section 13.
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
Version / remarks:
29 July 2016
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EPA, Health Effects Test Guidelines; OPPTS 870.3650:
Version / remarks:
July 2000
Deviations:
no
Specific details on test material used for the study:
Batch identification: 0013479406
Species:
rat
Strain:
Wistar
Remarks:
strain Crl:WI(Han)
Sex:
male/female
Route of administration:
oral: gavage
Dose / conc.:
0 mg/kg bw/day (nominal)
Dose / conc.:
100 mg/kg bw/day (nominal)
Dose / conc.:
300 mg/kg bw/day (nominal)
Dose / conc.:
1 000 mg/kg bw/day (nominal)
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: No test substance related adverse effects were observed.
Key result
Critical effects observed:
no
Conclusions:
The NOAEL from an OECD 422 combined repeated dose toxicity study with the reproductive/developmental screening test in Wistar rats by oral gavage on the read-across subtance was 1000 mg/kg bw/day. No signs of systemic toxicity were observed up to the highest dose of 1000 mg/kg bw/day. This result is applicable to the registered substance.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 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

under the conditions of the OECD 422 combined repeated dose toxicity study with the reproductive/developmental screening test in Wistar rats the oral administration of the read-across substance by oral gavage to male and female Wistar rats did not result in signs of systemic toxicity up to a dose level of 1000 mg/kg bw/d. Thus, the no observed adverse effect level (NOAEL) for general systemic toxicity was 1000 mg/kg bw/d for male and female Wistar rats.

Justification for classification or non-classification

The CLP classification criteria are not met.

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