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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:
key study
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:
review article or handbook
Title:
Unnamed
Year:
1982

Materials and methods

Type of sensitisation studied:
skin
Study type:
other: prospective clinical
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Prospective product safety testing with volunteers
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
50% in mineral oil

Method

Type of population:
general
Ethical approval:
not specified
Remarks:
informed consent
Subjects:
125 subjects ages 19-76 years
Route of administration:
dermal
Details on study design:
Repeated dose patch test, with patches containing 0.25 g of sample for 24 h to dorsal upper arm. Patches were applied to the same site each Monday, Wednesday and Friday of a 3 week induction period. Each site was scored for irritation a total of nine times. After a 14 day rest period, challenge patches were applied to both arms of each subject; the sites were graded for sensitisation reactions after 48 and 96 hours.

Results and discussion

Results of examinations:
No visible signs of irritation were noted.
No visible signs of skin sensitisation were noted. All scores were zero.

Applicant's summary and conclusion

Conclusions:
In a clinical study of 125 subjects, a repeated insult patch test was undertaken with the test substance (50% in mineral oil). There was no evidence of irritation or sensitisation.