Registration Dossier
Registration Dossier
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EC number: 937-130-0 | CAS number: -
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 5th to June 28th 2011
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate on April 7th 2010
- Limit test:
- no
Test material
- Reference substance name:
- Epoxy Resin T1600
- EC Number:
- 937-130-0
- IUPAC Name:
- Epoxy Resin T1600
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- The dosage forms were administrated from day 6 to day 20
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 300 & 1000 mg/kg/day
Basis:
analytical conc.
- No. of animals per sex per dose:
- 7 animals
- Control animals:
- yes
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Based on the results obtained in this study, the dose-level of 1000 mg/kg/day was a No Observed Adverse Effect Level (NOAEL) for maternal tolerance based on ptyalism in all females treated at this dose-level
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