Registration Dossier

Administrative data

Endpoint:
two-generation reproductive toxicity
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Title:
No information
Author:
Anonymous
Year:
2011
Bibliographic source:
NICNAS (Australia)

Materials and methods

Test guideline
Guideline:
OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Vehicle:
unchanged (no vehicle)
Details on exposure:
daily in diet
Doses / concentrations
Remarks:
Doses / Concentrations:
0;200;800;3200 ppm
Basis:
nominal in diet
No. of animals per sex per dose:
8

Results and discussion

Results: P0 (first parental animals)

Effect levels (P0)

open allclose all
Dose descriptor:
NOAEL
Effect level:
21 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: From two-generation reproductive tox study
Dose descriptor:
NOAEL
Effect level:
17 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
female
Basis for effect level:
other: From 90d repeated dose study

Results: F1 generation

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1
Effect level:
> 3 200 ppm (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: From two-generation reproductive tox study

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion