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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 23 May 2007 and 27 November 2007
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test procedures in accordance with accepted standard methods, well documented, limitation for developmental effects
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
See 7.8.1 Toxicity to reproduction: toxicity to reproduction. 001

Test animals

Species:
rat
Strain:
Sprague-Dawley
Details on test animals and environmental conditions:
See 7.8.1 Toxicity to reproduction: toxicity to reproduction. 001

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Analytical verification of doses or concentrations:
yes
Details on mating procedure:
See 7.8.1 Toxicity to reproduction: toxicity to reproduction. 001
Duration of treatment / exposure:
See 7.8.1 Toxicity to reproduction: toxicity to reproduction. 001
Frequency of treatment:
See 7.8.1 Toxicity to reproduction: toxicity to reproduction. 001
Duration of test:
Adult male: 42 days
Adult female: maximum 45 days (non pregnant females: animals were sacrificed after day 26 or later after mating)
Pups: 4 days
Doses / concentrations
Remarks:
Doses / Concentrations:
See 7.8.1 Toxicity to reproduction: toxicity to reproduction. 001
Basis:

No. of animals per sex per dose:
See 7.8.1 Toxicity to reproduction: toxicity to reproduction. 001
Control animals:
yes, concurrent vehicle

Examinations

Maternal examinations:
See 7.8.1 Toxicity to reproduction: toxicity to reproduction. 001
Ovaries and uterine content:
The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
Fetal examinations:
Pups examination
- External examinations: Yes: all per litter
- Soft tissue examinations: No
- Skeletal examinations: No
- Head examinations: No
Statistics:
See 7.8.1 Toxicity to reproduction: toxicity to reproduction. 001
Indices:
See 7.8.1 Toxicity to reproduction: toxicity to reproduction. 001

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:no effects

Effect levels (maternal animals)

Dose descriptor:
NOEL
Effect level:
1 000 mg/kg bw/day
Basis for effect level:
other: maternal toxicity

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion