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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
Study period:
No data
Rationale for reliability incl. deficiencies:
other:
Remarks:
Concentration employed in this study was not reported

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 35 (31 completed the study)
- Sex: no data
- Age: no data
- Race: no data
Clinical history:
No data
Controls:
None
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: no data
- Vehicle / solvent: no data
- Concentrations: no data
- Volume applied: no data
- Testing/scoring schedule: no data
- Removal of test substance: no data
- Other: application for 5 alternate day 48 hours periods. Patch site were pre-treated with 5% aqueous SLS under occlusion for the initial patch only. Following a 14-day rest period, challenge patches of all materials were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 30 minute application of 5% aqueous SLS under occlusion on the left side of the back whereas the test material were applied with SLS treatment on the left side and petrolatum on the right side.

EXAMINATIONS
No data

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: none

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 31
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:
Under the condition of the study, the test material is not a skin sensitiser.
Executive summary:

A panel of 31 human volunteers completed a maximization test in which the test material was applied to the back of the subjects under occlusive patches 5 alternate day 48 hours periods. Patch site were pre-treated with 5% aqueous SLS under occlusion for the initial patch only. Following a 14-day rest period, challenge patches of all materials were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 30 minute application of 5% aqueous SLS under occlusion on the left side of the back whereas the test material were applied with SLS treatment on the left side and petrolatum on the right side.

Under the conditions employed in this study, there was no evidence of sensitisation to the test material.