Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
other: read across based on OECD Toolbox v3.4
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Justification for type of information:
See attached full OECD Toolbox study results

Data source

Reference
Title:
No information
Author:
Anonymous
Year:
2016
Bibliographic source:
OECD Toolbox v3.4.0.17

Materials and methods

Test guideline
Guideline:
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
GLP compliance:
no

Test material

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

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Duration of treatment / exposure:
45/54d

Results and discussion

Effect levels

Key result
Dose descriptor:
NOEL
Effect level:
264 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: According to OECD TG422

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion