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Diss Factsheets

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:
2006
Report date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
Deviations:
yes
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.3800 (Reproduction and Fertility Effects)
Limit test:
no

Test material

Constituent 1
Test material form:
gas

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 generation)

General toxicity (P0)

Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Immunological findings:
not examined

Effect levels (P0)

Key result
Dose descriptor:
NOAEC
Effect level:
2 000 ppm
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs
mortality
body weight and weight gain
neuropathology
histopathology: non-neoplastic
reproductive function (sperm measures)

Target system / organ toxicity (P0)

Key result
Critical effects observed:
yes
Lowest effective dose / conc.:
10 000 ppm
System:
cardiovascular
Organ:
brain
heart
kidney
liver
Treatment related:
yes
Dose response relationship:
yes
Relevant for humans:
yes

Results: P1 (second parental generation)

Effect levels (P1)

Key result
Dose descriptor:
NOAEC
Effect level:
10 000 ppm
Based on:
test mat.
Sex:
male/female
Basis for effect level:
mortality
neuropathology

Target system / organ toxicity (P1)

Key result
Critical effects observed:
yes
Lowest effective dose / conc.:
50 000 ppm
System:
central nervous system
Organ:
brain
Treatment related:
yes
Dose response relationship:
yes
Relevant for humans:
yes

Results: F1 generation

Effect levels (F1)

Key result
Dose descriptor:
NOAEC
Generation:
F1
Effect level:
10 000 ppm
Based on:
test mat.
Sex:
male/female
Basis for effect level:
body weight and weight gain
organ weights and organ / body weight ratios

Target system / organ toxicity (F1)

Key result
Critical effects observed:
no

Results: F2 generation

Effect levels (F2)

Key result
Dose descriptor:
NOAEC
Generation:
F2
Effect level:
10 000 ppm
Based on:
test mat.
Sex:
male/female
Basis for effect level:
mortality
organ weights and organ / body weight ratios

Target system / organ toxicity (F2)

Key result
Critical effects observed:
no

Overall reproductive toxicity

Key result
Reproductive effects observed:
yes
Lowest effective dose / conc.:
10 000 ppm
Treatment related:
yes
Relation to other toxic effects:
reproductive effects occurring together with other toxic effects, but not as a secondary non-specific consequence of other toxic effects
Dose response relationship:
yes
Relevant for humans:
yes

Applicant's summary and conclusion