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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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

Constituent 1
Chemical structure
Reference substance name:
Ethyl acetate
EC Number:
205-500-4
EC Name:
Ethyl acetate
Cas Number:
141-78-6
Molecular formula:
C4H8O2
IUPAC Name:
ethyl acetate
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.