Registration Dossier
Registration Dossier
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EC number: 296-664-6 | CAS number: 92908-35-5
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: 90-d repeated dose study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data are given
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 983
Materials and methods
- Principles of method if other than guideline:
- Performed according to the NTP protocol
- GLP compliance:
- not specified
Test material
- Details on test material:
- - CAS number (as cited in study report): 1854-26-8
- Substance type: aqueous solution
- Physical state: liquid
- Purity: 41.4%
- Stability One lab stated that the test solutions would be stable for 2 weeks when stored in the dark at room temperature.
- Impurities (identity and concentrations): 0.8% formaldehyde
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- Exposure period: 90 d
- Frequency of treatment:
- 5x/wk.
Results and discussion
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Microscopic inspection of sex organs (including testis, epididymis, prostate, preputial gland/uterus, ovaries, clitoral gland) gave no indication to morphological abnormalities. No histopathological changes up to 3000 mg/kg/d in male rats and up to 6000 mg/kg/d (referring to 100 % substance) in female rats.
Applicant's summary and conclusion
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