Registration Dossier

Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Original study cited not reviewed. Included for completion only using information from a secondary source.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1989

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Human patch testing
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Formulation containing 97% ethyl acetate.

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 25
Route of administration:
dermal

Results and discussion

Any other information on results incl. tables

A challenge test 10 days after the final induction patch failed to elicit any skin reactions

Applicant's summary and conclusion

Executive summary:

The skin sensitization potential of a formulation containing 97% ethyl acetate has been evaluated in human repeated insult patch testing. Twenty-five subjects were patch-tested with 0.3 ml under occlusive conditions for five consecutive 48 -hr periods. A challenge test 10 days after the final induction patch failed to elicit any skin reactions.