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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable publication which meets basic scientific principles For justification of read across please refer to section 13.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976
Reference Type:
secondary source
Title:
Fragrance raw materials monographs - Isoamly alcohol
Author:
Opdyke DLJ
Year:
1978
Bibliographic source:
Food Chem. Tox. 16, S1, 785-788

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Human maximization study
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Substance No: 76-8-151

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 25
- Sex: 5 males, 20 females
- Age: 18 - 48 years
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Site: volar forearm or back of all subjects
- Vehicle / solvent: 2.5% aqueous sodium lauryl sulfate (SLS)
- Concentrations: 8%
- Testing/scoring schedule: Prior to challenge, 5-10% SLS was applied to the test site for one hour before application of the test material. Test material was applied under occlusion to the same site on the volar forearm or back of all subjects for five alternate-day 48 hour periods

Results and discussion

Results of examinations:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0/25
- Number of subjects with negative reactions: 25/25
- Number of subjects with equivocal reactions: 0/25
- Number of subjects with irritating reactions: 0/25

Applicant's summary and conclusion