Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Remarks:
combined repeated dose and reproduction / developmental screening
Type of information:
experimental study
Adequacy of study:
key study
Study period:
may 10th to november 22nd 2011
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Certificate on April 7th 2010
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
In the males :
- 2 weeks before pairing
- during the pairing period (up to 2 weeks)
- until sacrifice (at least 5 weeks in total)
In the females :
- 2 weeks before pairing
- during the pairing period (up to 2 weeks)
- during gestation
- during lactation until day 5 post-partum inclusive
- until sacrifice for females which had not delivered
Frequency of treatment:
Daily
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
100 mg/kg/day 20 mg/mL
Basis:
nominal in water
Remarks:
Doses / Concentrations:
300 mg/kg/day 60 mg/mL
Basis:
nominal in water
Remarks:
Doses / Concentrations:
1000 mg/kg/day 200 mg/mL
Basis:
nominal in water
No. of animals per sex per dose:
42 males
42 females
Control animals:
yes

Results and discussion

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Parental toxicity
Dose descriptor:
NOEL
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Toxic effects on progeny

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Based on the experimental conditions of this study :
- the No Observed Adverse Effect Level (NOAEL) for parental toxicity was considered to be 1000 mg/kg/day
- the No Observed Effect Level (NOEL) for toxic effects on progeny was considered to be 1000 mg/kg/day in the absence of any treatment-related effect on pups at this dose-level