Registration Dossier

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
Reliability:
4 (not assignable)

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
1974

Materials and methods

Study type:
study with volunteers
Principles of method if other than guideline:
A maximization test (Kligman, 1966; Kligman & Epstein, 1975) was carried out on 25 healthy male and female volunteers. Application was under occlusion to the same site on the forearms of all subjects for five alternate-day 48 hour periods. Patch test sites were pretreated for 24 hours with 5% aqueous sodium lauryl sulfate under occlusion. Following a ten day rest period, a challenge patch was applied to a fresh site for 48 hours under occlusion. Reactions to challege were read at patch removal and 24 hours after patch removal.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Route of administration:
dermal

Results and discussion

Results of examinations:
Vehicle was petrolatum
5 % sensitization effects
17/25 positive.

Applicant's summary and conclusion

Conclusions:
5 % sensitization effects
17/25 positive.