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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

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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:
1971
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

Constituent 1
Chemical structure
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
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.