Registration Dossier

Administrative data

Description of key information

Historical testing suggests positive sensitisation by repeat epicutanous testing.

Insufficient data to sub-categorise the classification.

The review document also references ear-swelling test on vanadium sulphate as being positive

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
repeat insult test (Buehler)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Source reference not found, but is cited in several handbooks
Qualifier:
equivalent or similar to
Guideline:
other: Buehler repeat exposure
Version / remarks:
Buehler repeat exposure
Principles of method if other than guideline:
Also references 'ear swelling' test, but no details of method in the review documents
GLP compliance:
no
Type of study:
Buehler test
Justification for non-LLNA method:
Historical study that provides a positive response
Specific details on test material used for the study:
Precise form of vanadium sulphate not specified
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
Described as 'albino' guinea pigs
Positive control results:
Non specified
Reading:
other: Not specified
Group:
test group
Dose level:
3% concentration
No. with + reactions:
80
Total no. in group:
80
Clinical observations:
Not specified
Remarks on result:
positive indication of skin sensitisation
Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
Insufficient data to sub-categorise the classification.
The review document also references ear-swelling test on vanadium sulphate as being positive
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Justification for classification or non-classification