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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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.