Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Insufficient for assessment A mixture containing 2-aminoethanol was tested

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Submission of Data by CTFA (2-5-63), repeated insult patch test, 81-0242-74
Author:
Hill Top Research
Year:
1981
Bibliographic source:
cited in: CIR (1983): J. Am. Coll. Toxicol. 2, 183-235
Reference Type:
secondary source
Title:
Unnamed
Year:
1980
Report Date:
1980
Reference Type:
secondary source
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Type of sensitisation studied:
skin
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Skin irritation of a base dye containing 2-aminoethanol was tested for skin sensitisation on human subjects.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- a mixture was tested containing only 11.47 % ethanolamine

Results and discussion

Any other information on results incl. tables

A dyeless base formulation containing ethanolamine 11.47 %, was tested at 5 and 25 % in ethanol (0.3 ml).

Method: A 24-hour semiocclusive patch was applied to upper arm 3 times a week for 3 days, challenge patches after 15 to 17 days; number of subjects tested: 165;

Results: mild erythema, definite papular response, definite edema, definite edema and papules were observed during the induction phase, no reactions were observed at challenge.

Applicant's summary and conclusion