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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
two-generation reproductive toxicity
Type of information:
experimental study
Adequacy of study:
key study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)

Test material

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

open allclose all
Dose descriptor:
NOEL
Effect level:
ca. 50 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other:
Dose descriptor:
NOEL
Effect level:
ca. 250 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other:
Dose descriptor:
NOEL
Effect level:
ca. 50 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other:
Remarks on result:
other:

Results: F1 generation

Effect levels (F1)

open allclose all
Dose descriptor:
NOEL
Generation:
F1
Effect level:
ca. 50 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other:
Dose descriptor:
NOEL
Generation:
F1
Effect level:
ca. 250 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other:

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion