Registration Dossier
Registration Dossier
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EC number: 701-436-0 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the O.E.C.D. test guideline 420 with GLP compliance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction products of 2-methylimidazole and 2,2'-[(1- methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane
- EC Number:
- 701-436-0
- Molecular formula:
- (C15H16O2.C4H6N2.C3H5ClO)x
- IUPAC Name:
- Reaction products of 2-methylimidazole and 2,2'-[(1- methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- As per IUCLID5 Sections 1.1. 1.2. 1.4. and 4.1.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The rats were acquired from Charles River (UK) Limited, Margate, Kent. They were 4-6 weeks old and weighing 104-120gm at the start of the study. The animals were maintained in an animal room held at 19-25°C and 30-70% relative humidity. The room was illuminated by fluorescent light to give an artificial cycle of 12 hours lightJl2 hours dark per day.
The animals were housed in groups of up to 5, by sex, in grid-bottomed cages suspended over cardboard lined excreta trays. A pelieted diet (SQC Rat and Mouse Maintenance Diet No. 1 Expanded, produced by Special Diets Services, Witham, Essex) and mains drinking water in polypropylene bottles were freely available. All animals placed on study were acclimatised for at least 5 days before dosing.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Remarks:
- The test substance was formulated in corn oil at a concentration of 200mg/mL.
- Details on oral exposure:
- All animals were fasted overnight before dosing. On the day of dosing (designated day one), five animals of each sex were administered as a single dose, by gavage, using a rubber catheter attached to a graded syringe. After dosing, animals were returned to their cages and permitted access to food.
- Doses:
- 2000 mg/Kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Following dosing,the animals were examined within approximately 30 minutes, one, 2 and 4 hours after dosing. Examinations were conducted daily thereafter for a further 14 days. The animals were weighed on days 1, 2, 3, 4, 8 and 15. All animals were weighed and then sacrficed by carbon dioxide asphyxiation at the end of the 15 day observation period. The animals were subject to a gross necropsy, which included the opening of the thoracic and visceral cavities, opening and examination of the stomach and representative sections of the gastro-intestinal tract and examination of the major organs.
- Statistics:
- No required.
Results and discussion
- Preliminary study:
- No mortality or adverse clinical signs were observed.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: No adverse clinical signs.
- Gross pathology:
- No abnormalities were detected.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The test substance is judged to be nontoxic by the acute oral route of exposure.
- Executive summary:
The test substance, Bisphenol A, epichlorohydrin polymer, 2-methylimidazole condensate, was accessed for acute oral toxicity to the rat in an O.E.C.D. test guideline 420 study. No mortality or adverse clinical signs were observed at a dose level of 2000 mg/Kg of body weight. Therefore, The test substance is judged to be nontoxic by the acute oral route of exposure
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