Registration Dossier
Registration Dossier
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EC number: 218-746-2 | CAS number: 2224-15-9
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Version / remarks:
- Adopted: 22 March 1996
- GLP compliance:
- yes
- Remarks:
- Japan Existing Chemical Data Base: All the tests reported were performed in accordance with the chemicals GLP under the Law concerning Examination and Regulation of Manufacture, etc. of Chemical Substances and also meet the requirements of the OECD GLP.
- Limit test:
- no
Test material
- Reference substance name:
- 2,2'-[ethylenebis(oxymethylene)]bisoxirane
- EC Number:
- 218-746-2
- EC Name:
- 2,2'-[ethylenebis(oxymethylene)]bisoxirane
- Cas Number:
- 2224-15-9
- Molecular formula:
- C8H14O4
- IUPAC Name:
- 2,2'-[ethylenebis(oxymethylene)]bisoxirane
- Details on test material:
- weight per epoxy: 115
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- water for injection
- Frequency of treatment:
- 1x / day
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 12.5 mg/kg bw/day (nominal)
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Mortality:
- no mortality observed
- Ophthalmological findings:
- not examined
- Immunological findings:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- 200 mg/kg: no pregnant females
50 mg/kg:
- fertility index ((number of pregnant females/number of pairs with succesful copulation) x 100) = 58.3%
- corpora lutea decrease
- implantation index (number of implantation scars / number of corpora lutea) = 28.5%
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 12.5 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reproductive performance
Results: F1 generation
General toxicity (F1)
- Mortality / viability:
- mortality observed, treatment-related
- Description (incidence and severity):
- 50 mg/kg: viability index (number of live pups on day 4 of lactation / number of live pups born) = 68.8% => only 12 pups, relevance 3 mortalities is unclear
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 50 mg/kg: body weight pups increased but normal since only limited number of pups per dam at this dose
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
- Other effects:
- no effects observed
- Description (incidence and severity):
- - No external abnormalities
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not examined
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not examined
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 12.5 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- mortality
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- yes
- Lowest effective dose / conc.:
- 50 mg/kg bw/day (actual dose received)
- Treatment related:
- yes
- Relation to other toxic effects:
- reproductive effects occurring together with other toxic effects, but not as a secondary non-specific consequence of other toxic effects
- Dose response relationship:
- yes
Applicant's summary and conclusion
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