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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
repeated dose toxicity: oral
Remarks:
other: OECD toolbox category approach
Type of information:
(Q)SAR
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: OECD toolbox category approach based on data from 5 related substance
Justification for type of information:
QSAR prediction: migrated from IUCLID 5.6

Data source

Reference
Title:
Guidance Document on the Validation of (Quantitative) Structure Activity Relationship Models
Author:
OECD
Year:
2007
Bibliographic source:
OECD Publisher. September, 2007

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The OECD toolbox was used and the OECD profilers for DNA binding by OASIS was run. The endpoint of interest was repeated dose toxicity tests.

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Documentation for the category approach is attached. Available data indicate that molecules in the category have similar physical chemical properties. 

The following LOELs were predicted for Allantoin: 989 mg/kg/day read-across value for rat and mouse; 1743 mg/kg/day trend analysis for rat; 1000 mg/kg/day read-across for rat.

Data and QSAR predictions (for molecules in the domain) indicate that repeated dose toxicity tests showed no effects for most endpoints at the highest dose tests (>450 mg/kg/day). The lowest reported effect concentration was 50 mg/kg/day (CAS 96 -31 -1).

Applicant's summary and conclusion