Registration Dossier

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:
documentation insufficient for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
In a pre-test a patch of the test item was applied to the back of 5 human volunteer and left under occlusion for 48 hours to determine if sodium lauryl sulfate pre-treatment was required. In the main maximization test the test item was applied under occlusion on the volar forearm of 25 subjects for 5 alternate-days for periods of 48 hours. The patch site was pre-treated for 24 hours with 5% aqueous sodium lauryl sulfate under occlusion. The challenge site was read on removal of the patch and 24 hours later.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Method

Type of population:
not specified
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 25
- Sex: male (18) and female (7)
- Age: 18-25
- Race: not specified
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Vehicle / solvent: no vehicle

PRE-TEST:
- Number of exposures: 1
- Exposure period: 48h
- Test group: 1 group of 5 subjects
- Control group: no
- Site: back
- Concentrations: undiluted
- Evaluation: 48h after challenge

MAIN STUDY:
- Number of exposures: 5
- Exposure period: 48h per exposure, with a 24h rest period between removal and re-application of the patch.
- Challenge after a 2 week rest period after the last induction patch.
- Test group: 1 group of 25 subjects
- Control group: no
- Site: volar forearm
- Concentrations: 8%
- Evaluation: 48 and 72h after challenge

Results and discussion

Results of examinations:
No reactions observed in any of the test subjects at the 48 and 72h reading following challenge.

Applicant's summary and conclusion

Conclusions:
The substance is not skin sensitising in humans.
Executive summary:

In the current study the contact sensitizing potential of the test item was assessed in 25 human volunteers.

In the pre-testing phase the test item patches of the test item were applied to the back of 5 human volunteer and left under occlusion for 48 hours. No subject had any irritation from the test item and it was decided to use SLS in the main test.

During the main maximization test the test item was applied under occlusion on the volar forearm of the subjects for 5 alternate-days for periods of 48 hours. The patch site was pre-treated for 24 hours with 5% aqueous sodium lauryl sulfate under occlusion. The challenge site was read on removal of the patch and 24 hours later.

The test item was found to not produce skin sensitization effects under the conditions of the test.