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EC number: 216-823-5 | CAS number: 1675-54-3
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was not conducted according to guideline/s and GLP but the report contains sufficient data for interpretation of study results
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 963
- Report date:
- 1963
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Acute study followed the method of Draize.
Draize, J.H., G. Woodard, and H.O. Calveri.: Methods for Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes. J. Pharmacol. Exp. Therap. 82:377-390 - GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane
- EC Number:
- 500-033-5
- EC Name:
- 4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane
- Cas Number:
- 25068-38-6
- Molecular formula:
- (C15 H16 O2 . C3 H5 Cl O)x
- IUPAC Name:
- 4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane
- Reference substance name:
- 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane
- EC Number:
- 216-823-5
- EC Name:
- 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane
- Cas Number:
- 1675-54-3
- Molecular formula:
- C21H24O4
- IUPAC Name:
- 2,2'-[propane-2,2-diylbis(4,1-phenyleneoxymethylene)]dioxirane
- Details on test material:
- ERL-2774
Purity- no data in report
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Male albino New Zealand rabbits, 3 to 5 months of age and averaging 2.5 kg. in weight were immobilized during the 24-hour skin contact period. Thereafter, the VINYLITE sheeting used to retain the dose in contact with the clipped skin of the trunk was removed and the animals were caged for the remainder of the 14-day observation period. The rabbits were procured locally and maintained on Rockland rabbit ration.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- The fur was removed from the entire trunk by clipping, and the dose was retained beneath an impervious sheeting.
- Duration of exposure:
- 24 hour
- Doses:
- up to 20ml/kg
- No. of animals per sex per dose:
- 4 male rabbits/dose
- Control animals:
- not specified
- Details on study design:
- Penetration of rabbit skin is estimated by a technique resembling a one-day cuff method of Draize, using groups of 4 male albino rabbits weighing 2.5 kg. The fur was removed from the entire trunk by clipping, and the dose was retained beneath an impervious sheeting. Doses greater than 20 ml/kg could not be retained in contact with the skin. The animals were immobilized for the 24-hour period, after which the film is removed and the rabbits were caged for the subsequent 14-day observation period. The LD50 was then calculated using the method of Thompson.
- Statistics:
- The LD50 was then calculated using the method of Thompson.
Thompson, W. R.: Use of Moving Averages and Interpolation to Estimate Median Effective Dose. Bacterial Rev. 11:115 (June 1947).
Results and discussion
- Preliminary study:
- No preliminary study conducted.
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 20 mL/kg bw
- Remarks on result:
- other: Dose was calculated to be 23,032 mg/kg from the reported dose of 20 mL/kg and density of 1.1516 g/mL.
- Mortality:
- No additional information provided.
- Clinical signs:
- other: No additional information provided.
- Gross pathology:
- No additional information provided.
- Other findings:
- Results were reported only as the LD50 > 20 mL/kg.
Dose was calculated to be 23,032 mg/kg from the reported dose of 20 mL/kg and density of 1.1516 g/mL.
A group of 4 rabbits survived the dose applied undiluted. The dose was the maximum amount of fluid that could be retained in contact with the skin beneath the sheeting. There was no indication of skin condition following the exposure.
Any other information on results incl. tables
No additional information provided.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The dermal LD50 in rabbits is >20 ml/kg bw (23,000 mg/kg).
- Executive summary:
Groups of 4 rabbits were dermally administered volumes of test material as high as 20 ml/kg bw. The dermal LD50 was >20 ml/kg (equivalent to approximately 23,000 mg/kg).
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