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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
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Analytical purity: 40.8%
- Lot/batch No.: 99072150

Test animals

Species:
rat
Strain:
Sprague-Dawley
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Nossan Srl
- Age at study initiation: 9 weeks
- Weight at study initiation: 200-287g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on mating procedure:
Each male was used to mate up to 3 females. Separation after successful mating.
Duration of treatment / exposure:
Day 6 to Day 19 (including) of gestation. Presence of vaginal plug or sperm in the vaginal smear were taken as signs of "Day 0" of gestation.
Duration of test:
20 days
No. of animals per sex per dose:
24
Control animals:
yes, concurrent vehicle

Examinations

Maternal examinations:
-Body weight
-Food consumption
-Clinical signs
Ovaries and uterine content:
-Gravid uterine weight
-Number of corpora lutea
-Number of implantations
-Evaluation of placenta
Fetal examinations:
-Litter size
-Number of dead foetuses (divided in early and late resoprtions)
-Foetal weight
-Sex ratio

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:yes

Details on maternal toxic effects:
Lower body weight development and lower food consumption in high dosed females.
Difficulty in movement, impairment of hindlimbs, hunched posture and emaciation in the high dosed group.
Significant reduction in uterus weight in high dosed animals, compared to the control.

Effect levels (maternal animals)

open allclose all
Dose descriptor:
NOAEL
Effect level:
2 mg/kg bw/day (nominal)
Basis for effect level:
other: maternal toxicity
Dose descriptor:
LOAEL
Effect level:
4 mg/kg bw/day (nominal)
Basis for effect level:
other: maternal toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Details on embryotoxic / teratogenic effects:
Mean foetal weight was statistically lower in high dosed animals, compared to the control. Higher incidence of small foetuses in high dosed animals, compared to the control. This finding is related to maternal toxicity.
Higher incidence of incompletely ossifications of sternebrae, metacarpals and metatarsals in high dosed animals, compared to the control. These findings are related to maternal toxicity.
No evidence of a teratogenic effect of the test substance was obtained.

Effect levels (fetuses)

open allclose all
Dose descriptor:
NOAEL
Effect level:
2 mg/kg bw/day (nominal)
Basis for effect level:
other: teratogenicity
Dose descriptor:
LOAEL
Effect level:
4 mg/kg bw/day (nominal)
Basis for effect level:
other: teratogenicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
No evidence of a teratogenic effect of the test substance was obtained. The information contained within this robust summary document comes from studies which are in the ownership of Arch Chemicals Inc. and which are protected in several regions globally. This information may not be used for any purpose other than in support of the Chemical safety Report submitted by Arch Chemicals Inc. under Regulation EC 1907/2006.