Registration Dossier
Registration Dossier
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EC number: 619-738-5 | CAS number: 87305-03-1
Toxicity to reproduction
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 for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
- GLP compliance:
- yes
Test material
- Reference substance name:
- (1R,4R,5S)-6,6-dimethyl-4-(tribromomethyl)-3-oxabicyclo[3.1.0]hexan-2-one
- Cas Number:
- 87305-03-1
- Molecular formula:
- C8H9Br3O2
- IUPAC Name:
- (1R,4R,5S)-6,6-dimethyl-4-(tribromomethyl)-3-oxabicyclo[3.1.0]hexan-2-one
Constituent 1
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 generation)
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
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Other effects:
- effects observed, treatment-related
Reproductive function / performance (P0)
- Reproductive function: oestrous 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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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