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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Experimental data from a human repeat insult patch test. Detailed information on methods and results not available

Data source

Reference
Reference Type:
grey literature
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Human Repeat Insult Patch Test
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
Study undertaken prior to the introduction of the LLNA (OECD TG 429 originally adopted April 2002)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
No data

In vivo test system

Test animals

Species:
human
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
no data
Concentration / amount:
no data
Challenge
Route:
epicutaneous, occlusive
Vehicle:
no data
Concentration / amount:
no data
No. of animals per dose:
53 subjects
Details on study design:
No data
Challenge controls:
No data
Positive control substance(s):
not specified

Results and discussion

Positive control results:
No data

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
other: No data
Group:
test group
Dose level:
No data
No. with + reactions:
34
Total no. in group:
53
Remarks on result:
positive indication of skin sensitisation
Reading:
other: n/a
Group:
negative control
Dose level:
n/a
Remarks on result:
not measured/tested
Remarks:
Human repeat insult patch test - No negative control group
Reading:
other: n/a
Group:
positive control
Dose level:
n/a
Remarks on result:
not measured/tested
Remarks:
Human repeat insult patch tests - No positive control

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The substance is a skin sensitiser
Executive summary:

Skin sensitisation has been investigated in a human repeat insult patch test. A total of 34 of 53 subjects showed skin reaction during induction and challenge