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EC number: 217-316-1 | CAS number: 1809-19-4
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- other: read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Study period:
- 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- EFSa scientific report
- Justification for type of information:
- Justification for Read Across is provided in Section 13 of IUCLID
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Conclusion regarding the peer review of the pesticide risk assessment of the active substance fosetyl
- Author:
- EFSA
- Year:
- 2 005
- Bibliographic source:
- European Food Safety Authority, 2005. Conclusion on the peer review of the pesticide risk assessment of the active substance fosetyl. EFSA Scientific Report (2005) 54, 1-79.
- Reference Type:
- secondary source
- Title:
- EPA memorandum
- Author:
- EPA
- Year:
- 1 990
- Bibliographic source:
- Second Carcinogenicity Peer Review of Aliette
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- insufficient number of days of exposure
- Principles of method if other than guideline:
- Eighty (20 per group) mature CFY strain SPF female rats were treated from day 6 to day 15 of pregnancy inclusively by oral gavage of 2.0 mL/100 g of a solution of the test item in sterile distilled water at the following concentrations: 0, 500, 1000 and 4000 mg/kg bw.
- GLP compliance:
- no
Test material
- Reference substance name:
- Source Chemical 06
- IUPAC Name:
- Source Chemical 06
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CFY
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- 2.0 mL/100 g of a solution of the test item in sterile distilled water at the following concentrations: 0, 500, 1000 and 4000 mg/kg bw.
- Details on mating procedure:
- No data
- Duration of treatment / exposure:
- From day 6 to day 15 of pregnancy
- Frequency of treatment:
- Once per day
- Duration of test:
- 20 days.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 4 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 20 female rats per dose
- Control animals:
- yes, concurrent no treatment
Examinations
- Maternal examinations:
- On day 20 of pregnancy all animals were sacrificed, dissected and observed for macroscopic pathological changes in maternal organs.
- Fetal examinations:
- On day 20 of pregnancy all animals were sacrificed. Live young were examined externally. The pups in each litter were then examined for visceral and skeletal malformations.
- Indices:
- In the controls, 500 and 1000 mg/kg groups, 1/20 mated animals. All the females from the high dose group were pregnant.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Test item treatment in rats caused maternal toxicity (5/20 pregnant dams died, retarded body weight gain) at the highest dose tested (4000 mg/kg bw/day), when administered orally by gavage from day 6 to day 15 of pregnancy inclusively.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- ca. 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- early or late resorptions
- mortality
- Dose descriptor:
- LOEL
- Effect level:
- ca. 4 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- early or late resorptions
- mortality
Maternal abnormalities
- Abnormalities:
- not specified
Results (fetuses)
- Fetal body weight changes:
- effects observed, treatment-related
- Skeletal malformations:
- effects observed, treatment-related
- Description (incidence and severity):
- Delayed ossification
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOEL
- Remarks:
- developmental toxicity
- Effect level:
- ca. 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- fetal/pup body weight changes
- skeletal malformations
- Dose descriptor:
- LOEL
- Remarks:
- developmental toxicity
- Effect level:
- ca. 4 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- fetal/pup body weight changes
- skeletal malformations
Fetal abnormalities
- Abnormalities:
- effects observed, treatment-related
- Localisation:
- other: delayed ossification
Overall developmental toxicity
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 4 000 mg/kg bw/day (nominal)
- Treatment related:
- yes
- Relation to maternal toxicity:
- developmental effects occurring together with maternal toxicity effects, but not as a secondary non-specific consequence of maternal toxicity effects
- Dose response relationship:
- yes
Applicant's summary and conclusion
- Conclusions:
- NOEL (maternal toxicity) = 1000 mg/kg bw/day
NOEL (development) = 1000 mg/kg bw/day - Executive summary:
The developmental toxicity of the substance was evaluated in an experimental study whereby groups of 20 gravid female CFY rats were administered 2.0 mL/100 g test item in sterile distilled water from day 6 to day 15 of pregnancy inclusively via oral gavage at concentrations of 500, 1000 and 4000 mg/kg bw/day for 20 days, alongside a vehicle control group tested in parallel.
As a result of maternal toxicity at highest dose level, litter weight and mean foetal weight were reduced, total resorptions were increased and delayed ossification of fetuses were observed. At 1000 mg/kg bw/day, it can be said that developmental effects occurred together with maternal toxicity effects, but not as a secondary non-specific consequence of maternal toxicity effects. At 500 and 1000 mg/kg bw/day there were no conclusive effects on either maternal or foetal parameters.
Based on the early resorptions, reduced body weight gain and mortality observed at the highest dose administered of 4000 mg/kg bw/day, the NOEL for maternal toxicity was set at 1000 mg/kg bw/day. Based on the delayed ossification, poor body weight and body weight gains and increased total resorptions of offspring at the highest dose, the NOAEL for developmental toxicity was expressed as 1000 mg/kg bw/day, however, it should be ruled out that it cannot be ruled out that these observations were effects of maternal toxicity.
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