Registration Dossier

Administrative data

Endpoint:
skin sensitisation, other
Remarks:
HRIPT Human Repeated Insult Patch Test
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: HRIPT 50 subjects
Deviations:
not specified
Principles of method if other than guideline:
- Principle of test: Repeated Insult Patch Test 50 Subjects
GLP compliance:
yes (incl. certificate)
Type of study:
patch test
Justification for non-LLNA method:
Human data available

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: flakes

In vivo test system

Test animals

Species:
other: Human
Sex:
male/female

Results and discussion

In vivo (non-LLNA)

Results
Key result
Reading:
other: Readings at 24/48/72 h
Hours after challenge:
72
Group:
test group
Dose level:
test material dilutet to 10% in mineral oil, occlusive
No. with + reactions:
0
Total no. in group:
53
Clinical observations:
one (I) subject exhibited a ± Ievel reaction at the 24 and 48 hour readings, which diminished to a zero (0) Ievel at the 72 hour reading.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the test population of fifty-three (53) subjects and under the conditions of this study, the test material demonstrated no potential for eliciting either dermal irritation or sensitization