Registration Dossier
Registration Dossier
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EC number: 410-510-9 | CAS number: 86753-82-4
Developmental toxicity / teratogenicity
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:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 87/302 , Part B OECD 414
- GLP compliance:
- yes
- Limit test:
- no
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Details on exposure:
- Method of administration or exposure: GavageMass median aerodynamic diameter:Not applicable
- Frequency of treatment:
- Dosing regime: 7 days/week
- No. of animals per sex per dose:
- Number of dams and doses24 at 0 mg/kg or mg/l24 at 50 mg/kg or mg/l24 at 200 mg/kg or mg/l24 at 1000 mg/kg or mg/l
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Details on maternal toxic effects:Treatment of pregnant females during day 6 to day 16 ofgestation inclusive, did not reveal any signs of maternaltoxocity.All mated females (except one) were pregnant and nodifferences were seen in the number of corpora lutea, thenumber of implantations, the pre- and post-implantation lossand the incidence of embryonic/foetal deaths.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Details on embryotoxic / teratogenic effects:Effects on fetus - Gross:No foetal deaths occurred among treated litters. Sex ratios were normal in litters of dams treated with substance.The total foetal weights and foetal weights of the sexes separately revealed no test substance-related changes.
Effects on fetus -
Soft tissue: There were no external findings that were concidered to have arisen as a result of treatment of dams with the substance. There were no morphological changes detected at visceral examination of the foetuses.
Skeletal: Skeletal examinations revealed no changes in the ossification of the foetal skeleton at dose up to 1000 mg/kg body weight/day. Treatment of dams at 1000 mg/kg/day slightly increased the incidences of supernumerary ribs and wavy ribs.
Effect levels (fetuses)
open allclose all
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 200 mg/kg bw/day
- Basis for effect level:
- other: embryotoxicity
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no dose dependent effects except for slightly increased incidence of spontaneous variations at the highest dose.
Fetal abnormalities
open allclose all
- Abnormalities:
- effects observed, non-treatment-related
- Localisation:
- skeletal: supernumerary rib
- Description (incidence and severity):
- slight increase in incidence (frequent spontaneous variation)
- Abnormalities:
- effects observed, non-treatment-related
- Localisation:
- other: wavy rib
- Description (incidence and severity):
- silght increase in incidence (frequent spontaneous variation)
Overall developmental toxicity
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Treatment related:
- no
- Relation to maternal toxicity:
- not specified
- Dose response relationship:
- no
- Relevant for humans:
- no
Applicant's summary and conclusion
- Conclusions:
- Based on the results in this embryotoxicity and teratogenicy study, the definitive No Observed Effect Level (NOEL) was established as being 200 mg/kg bw/day. The NOAEL was considered as 1000 mg/kg bw/ day.
- Executive summary:
Oral dosing of pregnant female Wistar rats with Hypersol synergist L 4722 at dose levels of 50, 200 or 1000 mg/kg bw/day during day 6 to 16 of gestation inclusive, was associated with a very slight increase in the total number of foetuses with supernumerary rib(s) or with wavy ribs, but there were no other indications of adverse effects upon in utero development of foetuses.
Based on the results in this embryotoxicity and teratogenicy study, the definitive No Observed Effect Level (NOEL) was established as being 200 mg/kg bw/day. The NOAEL was considered as 1000 mg/kg bw/ day.
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