Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report Date:
1969

Materials and methods

Test guideline
Version / remarks:
No OECD test guideline for skin sensitisation available when test was performed.
Principles of method if other than guideline:
not specified
GLP compliance:
no
Remarks:
GLP was not yet introduced at the time when the study was conducted.
Type of study:
not specified
Justification for non-LLNA method:
A skin sensitisation study was conducted on 6 guinea pigs. The test protocol which has not been specified in more detail in the study report is supposed to comply with one of various available guinea pig skin sensitization test protocols that measure cutaneous erythema and edema in suitably sensitized and challenged animals. At the time when the study was performed the ear flank test was a routine method. In this test, solutions of suspected sensitizing substance were applied over three days to the ears of guinea-pigs, and the flanks were challenged one week later with a range of concentrations of suspected sensitizing substance. The erythematous reaction produced 24 hours after challenge was rated and compared with that in unsensitized controls. Another non-adjuvant assay established at that time is the Buehler test.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
The test material was a product of the direct chlorination of a 60/40 weight percent mixture of meta/para vinyl toluene. The actual ratio of the isomers was unknown.

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

No. of animals per dose:
6
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
other: positive (observed sensitisation response)
Group:
test group
Dose level:
not specified
No. with + reactions:
4
Total no. in group:
6
Reading:
other:
Group:
negative control
Remarks on result:
not determinable because of methodological limitations
Reading:
other:
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
Skin sensitisation studies conducted on guinea pigs resulted in a sensitivity response in 4 out of 6 of the surviving animals.
Executive summary:

Skin sensitisation studies conducted on guinea pigs resulted in a sensitivity response in 4 out of 6 of the surviving animals.