Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Human skin reactions to ethylene oxide
Author:
SHUPACK, J.L., ANDERSEN, S.R., & ROMANO, S.J.
Year:
1981
Bibliographic source:
J. Lab. clin. Med., 98: 723-729

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
patch test

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

In vivo test system

Test animals

Species:
human

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Vehicle:
other: polyvinyl chloride
Concentration / amount:
100 mg ethylene oxide/kg
Challengeopen allclose all
Vehicle:
other: polyvinyl chloride
Concentration / amount:
100 mg ethylene oxide/kg

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test chemical
Dose level:
100mg/kg
No. with + reactions:
1
Total no. in group:
12
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: 100mg/kg. No with. + reactions: 1.0. Total no. in groups: 12.0.

Applicant's summary and conclusion