Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
up to 1985
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Due to both the poor description of the study and the very weak irritating potential of the compound a verification of the results described is lacking.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1985

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:
Twelve control persons were testes with 100 % test substance in a patch test. .
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
not reported

Method

Type of population:
not specified
Ethical approval:
not specified
Subjects:
Twelve control persons were testes with 100 % test substance. Gender, health status and possible allergic predispositions of test persons
not specified.
Clinical history:
not specified
Controls:
no data
Route of administration:
dermal
Details on study design:
Twelve control persons were testes with 100 % test substance.
TYPE OF TEST(S) USED: patch test (epicutaneous test)

Results and discussion

Results of examinations:
Three/12 persons showed no, 7/12 doubtful and 2/12 positive reaction to the test substance after 24 h, but not after 48 and 72 hours, respectively. The reactions observed were assessed to be possibly irritating but not sensitizing effects and it was concluded that sensitization might occur more frequently due to prolonged and close skin contact of pads containing the
substance. A clear cut explanation for the observations made was not given.

Applicant's summary and conclusion

Conclusions:
Due to both the poor description of the study and the very weak irritating potential of the compound a verification of the results described is lacking.