Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1972

Materials and methods

Type of sensitisation studied:
skin
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Human patch test on compounded perfumes for toilet goods.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
general
Subjects:
- Number of subjects exposed= 7703

- Other: Subjects with dermatoses.
Clinical history:
- Other: Humans older than 18 years
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: Closed patch test

Duration: 24-48 hours

ADMINISTRATION

- Site of application: Upper inside of arm
- Vehicle / solvent = Ethanol 99%, Non-irritative cream base
- Concentrations = 0.05 - 0.5 %


Results and discussion

Results of examinations:
Erythema reaction in one subject


Applicant's summary and conclusion

Conclusions:
In a closed human patch study the test item was tested. Only in one subject erythema reactions were found. According to this result the test item is considered to be non sensitizing.
Executive summary:

In a closed human patch study the skin sensitizing potential of the test item was tested. The test was conducted with 7703 subjects suffering from dermatoses. The test item item was applicated to the upper inside of the arm. Ethanol 99% and a non-irritative cream base were used as vehicle. A concentration of 0.05 -0.5 % were applicated. Only in one subject erythema reactions were found. According to this result the test item can be considered as not sensitizing.