Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
results derived from a (Q)SAR model, with limited documentation / justification
Justification for type of information:
QSAR prediction

Data source

Reference
Reference Type:
other: Predicted data
Title:
Unnamed
Year:
2016

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: REACH guidance on QSARs R.6, May/July2008
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Results and discussion

Effect levels

Dose descriptor:
NOEL
Effect level:
97.1 mg/kg bw/day (nominal)
Based on:
other: Database: Repeated Dose Toxicity HESS
Remarks on result:
other: Oral: gavage, rat

Target system / organ toxicity

Critical effects observed:
not specified
Relevant for humans:
not specified

Applicant's summary and conclusion

Conclusions:
According to (Q)SAR modell: QSAR Toolbox, the predicted value indicated that cis-HPD-tartarate causes severe toxic effects (target organ toxicity). The result meets the requirement of STOT-RE Category 2.