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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
toxicity to reproduction
Remarks:
other: 28 d repeated dose study
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Principles of method if other than guideline:
Reinblau RLW Tr. was administered by oral gavage to male and female SD rats for 28 days at dose levels of 0, 8, 40, 200, and 1000 mg/kg to asses its toxicity and reversibility. At the end of the treatment period or an additional revovery period all animals were killed at day 29 or day 43 and necropsied; gross and microscopic examination of all major organs, including reproductive organs.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Reinblau RLW Tr. (CAS No. 41611-76-1, Lot No. 25C, Purity: 99.7%) was provided by Bayer Co., Ltd. and used in this study.

Test animals

Species:
rat
Strain:
other: Crj:CD (SD) IGS rats (48 males and 48 females) were obtained from Charles Liver Laboratories Japan Ltd.
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: The test substance was suspended in the vehicle (0.5% CMC-Na solution)
Details on mating procedure:
not applicable
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
28 days
Frequency of treatment:
once daily in the morning for 28 days.
Details on study schedule:
6 male and 6 female rats of the control, 8, 40, 200 and 1000 mg/kg bw dose group were necropsied on day 29; additionally 6 male and 6 female rats of the control, 200, and 1000 mg/kg bw dose group were necropsied after the recovery period on day 43.
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 8, 40, 200, or 1000 mg/kg
Basis:
other: nominal value
No. of animals per sex per dose:
control: 6 male and 6 female rats in the control, 8, 40, 200 and 1000 mg/kg bw dose group
recovery group: 6 male and 6 female rats in the control, 200, and 1000 mg/kg bw dose group
Control animals:
yes, concurrent vehicle

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

There were no test substance-related toxic changes in organs weights of testis and ovaries. No histopathological changes were found in testis, ovaries and all other examined organs. Additional no changes were seen relating to in clinical signs, body weight, food consumption, hematology, blood chemistry and urinalysis.

Applicant's summary and conclusion

Conclusions:
Fertility is not affected at doses of 1000 mg/kg bw for 28 days
Executive summary:

Reinblau RLW Tr. was administered by oral gavage to male and female SD rats for 28 days at dose levels of 0, 8, 40, 200, and 1000 mg/kg to assess its toxicity and reversibility. At the end of the treatment period or an additional revovery period all animals were killed at day 29 or day 43 and necropsied; gross and microscopic examination of: all major organs, including reproductive organs.

There were no test substance-related toxic changes in clinical sign, body weight, food consumption, hematology, blood chemistry, urinalysis, organ weight, necropsy, or histopathology.

No evidence of toxicity to reproduction was observed in a subacute repeated dose study as no treatment-related changes were observed for any reproductive organ investigated during macroscopic and microscopic examination. On the basis of this study no effects on fertility were expected (NOEL, rat: 1000 mg/kg bw/day).