Registration Dossier

Administrative data

Description of key information

In a subacute study 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.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
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
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
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
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.
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
Dose descriptor:
NOEL
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Critical effects observed:
not specified

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

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
The materials/methods and results are described in detail und are sufficient for evaluation

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There were no test substance-related toxic changes in clinical signs, 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.


Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
key study is used

Justification for classification or non-classification

Due to the results of the aubacute toxicity study were no effects in any parameters examined were found, a classification is not justified.