Registration Dossier

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:
2005
Report Date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
Qualifier:
according to
Guideline:
EPA OPPTS 870.3800 (Reproduction and Fertility Effects)
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

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

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure (if applicable):
nose/head only

Results and discussion

Results: P0 (first parental animals)

Effect levels (P0)

Dose descriptor:
NOEC
Effect level:
2 000 ppm
Based on:
test mat.
Sex:
female
Basis for effect level:
mortality
body weight and weight gain
gross pathology
histopathology: non-neoplastic
histopathology: neoplastic

Results: F1 generation

Effect levels (F1)

Dose descriptor:
NOEL
Generation:
F1
Effect level:
2 000 ppm
Based on:
test mat.
Sex:
female
Basis for effect level:
clinical signs
mortality
body weight and weight gain
organ weights and organ / body weight ratios
histopathology: non-neoplastic
histopathology: neoplastic

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion