Registration Dossier
Registration Dossier
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EC number: 216-823-5 | CAS number: 1675-54-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- not stated
- 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:
- publication
- Title:
- Unnamed
- Year:
- 1 958
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Rabbits were orally gavaged with test material and observed for 10 days. Survivors were sacrificed and necropsied with selected tissues saved for histopathologic examination.
- 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:
- EPON 828 (25068-38-6)
Purity- No data reported
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- other: albino
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- male albino rabbits (2.0-3.2 kg).
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- acetone
- Details on oral exposure:
- Single intragastric administrations were given to male albino rabbits (2.0-3.2 kg). Due to high viscosity, EPON 828 was delivered as a 95% solution with 5% acetone.
- Doses:
- No additional information provided.
- No. of animals per sex per dose:
- No additional information provided.
- Control animals:
- not specified
- Details on study design:
- Single intragastric administrations were given to male albino rabbits (2.0-3.2 kg). Due to high viscosity, EPON 828 was delivered as a 95% solution with 5% acetone. The animals were observed for the following 10 days, and survivors were necropsied. Sections of tissues were preserved in formalin for histologic examination. LD50 values were calculated according to the method of Litchfield and Wilcoxon (1948) or the method of Weil (1952).
Litchfield, J. T., Jr., and Wilcoxon, F.; A Simplified Method of Evaluating Dose-Effect Experiments, J Pharmacol. & Exper. Therap. 96:99-113, 1949.
Weil, C. S.: Tables for Convenient Calculation of Median Effective Dose and Instructions for Their Use, Biometrics, 8:249-263, 1952. - Statistics:
- LD50 values were calculated according to the method of Litchfield and Wilcoxon (1948) or the method of Weil (1952).
Litchfield, J. T., Jr., and Wilcoxon, F.; A Simplified Method of Evaluating Dose-Effect Experiments, J Pharmacol. & Exper. Therap. 96:99-113, 1949.
Weil, C. S.: Tables for Convenient Calculation of Median Effective Dose and Instructions for Their Use, Biometrics, 8:249-263, 1952.
Results and discussion
- Preliminary study:
- No preliminary study conducted.
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 19 800 mg/kg bw
- Remarks on result:
- other: Given 95% EPON 828 in 5% acetone.
- Mortality:
- no data
- Clinical signs:
- other: no data
- Gross pathology:
- Gross pathology was nonspecific, and the chief effect was that of local irritation.
- Other findings:
- The LD50 was reported to be 19,800 mg/kg. There are no specific observations or findings noted for EPON 828.
Any other information on results incl. tables
The LD50 was reported to be 19,800 mg/kg. There are no specific observations or findings noted for EPON 828.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The LD50 in male rabbits given 95% EPON 828 in 5% acetone was reported to be 19,800 mg/kg .
- Executive summary:
The LD50 in male rabbits given 95% EPON 828 in 5% acetone was reported to be 19,800 mg/kg .
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