Registration Dossier

Administrative data

Endpoint:
one-generation reproductive toxicity
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 March 2004 to 04 November 2004
Reliability:
1 (reliable without restriction)
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 415 (One-Generation Reproduction Toxicity Study)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Vehicle:
acetone
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
The test item fortified food was sampled for active ingredient analysis at the start of the treatment (concentration determined from samples collected for the homogeneity test) and once in 3 month intervals thereafter
No. of animals per sex per dose:
30 male and 30 female/dose
Details on study design:
30 male and 30 female, vehicle control, dose: 0 ppm

Results and discussion

Results: P0 (first parental animals)

General toxicity (P0)

Clinical signs:
no effects observed
Body weight and weight changes:
effects observed, treatment-related
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Other effects:
effects observed, treatment-related

Reproductive function / performance (P0)

Reproductive function: estrous cycle:
no effects observed
Reproductive function: sperm measures:
no effects observed
Reproductive performance:
no effects observed

Effect levels (P0)

open allclose all
Dose descriptor:
NOAEL
Remarks:
reproduction
Effect level:
> 70 - < 93 mg/kg bw/day (nominal)
Sex:
male/female
Dose descriptor:
NOAEL
Remarks:
toxicity
Effect level:
> 3.5 - < 4.9 mg/kg bw/day (nominal)
Sex:
male/female

Results: F1 generation

General toxicity (F1)

Clinical signs:
effects observed, treatment-related
Mortality / viability:
no mortality observed
Body weight and weight changes:
effects observed, treatment-related
Sexual maturation:
effects observed, treatment-related
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Gross pathological findings:
no effects observed
Histopathological findings:
no effects observed

Details on results (F1)




CLINICAL SIGNS (OFFSPRING)


BODY WEIGHT (OFFSPRING)


SEXUAL MATURATION (OFFSPRING):
Age but not weight at vaginal opening, Age but not weight at preputial separation


ORGAN WEIGHTS (OFFSPRING)


GROSS PATHOLOGY (OFFSPRING)


HISTOPATHOLOGY (OFFSPRING)


OTHER FINDINGS (OFFSPRING)

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion