Registration Dossier

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:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
patch test

Test material

Reference
Name:
Unnamed
Type:
Constituent

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 group
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