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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not reported
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Information from migrated NONS file, as per inquiry number 06-2120030080-80-0000 permission to refer granted by ECHA.
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
Reported as "Annex V (Maximisation test)"
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Route:
intradermal
Vehicle:
other: intradermal - sesame oil and adjuvent mixture; epidermal - vaseline
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal: 1% in sesame oil and in adjuvant mixture
Epidermal: 20% in vaseline

Concentration of test material and vehicle used for each challenge: 10% in vaseline
Route:
epicutaneous, open
Vehicle:
other: intradermal - sesame oil and adjuvent mixture; epidermal - vaseline
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal: 1% in sesame oil and in adjuvant mixture
Epidermal: 20% in vaseline

Concentration of test material and vehicle used for each challenge: 10% in vaseline
No. of animals per dose:
20 (test group)
10 (negative control group)
Positive control substance(s):
not specified

Signs of irritation during induction: None

Evidence of sensitisation of each challenge concentration: None

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
There was no evidence of sensitisation at any challenge concentration tested and as such the substance was determined to be a non-sensitiser.
Executive summary:

In a study conducted in accordance with the Standard Annex V method (Maximisation test) under conditions of GLP, the substance did not elicit any signs of sensitisation at any concentration tested and therefore is considered to be a non-sensitiser.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In a study conducted in accordance with the Standard Annex V method (Maximisation test) under conditions of GLP, the substance did not elicit any signs of sensitisation at any concentration tested and therefore is considered to be a non-sensitiser.


Migrated from Short description of key information:
Information from migrated NONS file, as per inquiry number 06-2120030080-80-0000 permission to refer granted by ECHA.

Justification for selection of skin sensitisation endpoint:
Only available data source.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the results of the available study summary, the substance does not meet the criteria for classification for skin sensitisation.

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