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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
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.
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)
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
28 days
Frequency of treatment:
once daily in the morning for 28 days.
Doses / concentrations
Remarks:
Doses / Concentrations:
of 0, 8, 40, 200, and 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

Effect levels

Dose descriptor:
NOEL
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

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

Applicant's summary and conclusion

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 asses its toxicity and reversibility.

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

Therefore, the no-observed-effect-level (NOEL) of Reinblau RLW Tr. was considered to be 1000 mg/kg for male and female rats.