Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No OECD Guideline study for GLP defined, no data on purity of test sample, no dose defined, no sex defined.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
In a study in 7 volunteers (no sex defined) the test substance (no dose defined) was applied to the right forearm and fixed with a ball of absorbent cotton and adhesive bandage for 24 hours. The observation period was 7 days.
GLP compliance:
not specified

Test material

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

Method

Type of population:
not specified
Ethical approval:
not specified
Controls:
no data
Route of administration:
dermal

Results and discussion

Results of examinations:
In a study in 7 humans the test substance (no dose defined) was applied to the right forearm and fixed with a ball of absorbent cotton and adhesive bandage for 24 hours. The observation:7d. No skin irritating or corrosive effects could be observed.

Any other information on results incl. tables

No skin irritation or corrosive effects could be observed.

Applicant's summary and conclusion

Executive summary:

In a study in 7 volunteers (no sex defined) the test substance (no dose defined) was applied to the right forearm and fixed with a ball of absorbent cotton and adhesive bandage for 24 hours. The observation period was 7 days.

No skin irritation or corrosive effects could be observed.