Registration Dossier
Registration Dossier
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EC number: 200-849-9 | CAS number: 75-21-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Toxicity of residuals from ethylene oxide gas sterilization.
- Author:
- G. Woodard and M. Woodard
- Year:
- 1 971
- Bibliographic source:
- cited in HIA Technical Symposium
- Report date:
- 1971
Materials and methods
- Principles of method if other than guideline:
- no further details given
- GLP compliance:
- no
- Type of study:
- not specified
- Justification for non-LLNA method:
- The study has been conducted prior to the implementation of the LLNA.
Test material
- Reference substance name:
- Ethylene oxide
- EC Number:
- 200-849-9
- EC Name:
- Ethylene oxide
- Cas Number:
- 75-21-8
- Molecular formula:
- C2H4O
- IUPAC Name:
- oxirane
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source: Matheson Company
- Purity: 99.7% by weight minimum
- Physical appearance: liquid
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Solutions were made with distilled water within an hour or two of use.
- Final dilution of a stock liquid: 25 mg/ml
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Flow Laboratories
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature-controlled environment
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Concentration / amount:
- 0.1% / 0.1 ml
- Route:
- epicutaneous, occlusive
- Concentration / amount:
- 1% / 0.5 ml
Challengeopen allclose all
- Route:
- intradermal
- Concentration / amount:
- 0.1 ml
- Route:
- epicutaneous, occlusive
- Concentration / amount:
- 0.5 ml
- No. of animals per dose:
- 10
- Details on study design:
- Three applications per week for three weeks with a challenge two weeks after the last application.
The dermal application wad made using 0.5 ml of the test sustance on a 1 x 1 inch, four layer pad covered by an Elastopatch and further covered by rubber damming. The animals were then placed in a specially designed holder for a 6-hour exposure period. The intracutaneous application was made by injecting 0.1 ml of the test material.
Results and discussion
In vivo (non-LLNA)
Results
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The results were entirely negative.
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