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Toxicological information

Toxicity to reproduction

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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:
1983

Materials and methods

Principles of method if other than guideline:
Performed according to the NTP protocol
GLP compliance:
not specified

Test material

Constituent 1
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

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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