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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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, other
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 2006 - January 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods
Qualifier:
according to guideline
Guideline:
other: standard RIPT protocol
Version / remarks:
the study was performed according to ICH Guideline E6 for Good clinical practice and requirements provided for in 21 CFR parts 50 and 56.
GLP compliance:
no
Remarks:
GCP compliance
Type of study:
patch test
Species:
other: human
Sex:
male/female
Details on test animals and environmental conditions:
63 qualified subjects, male and female, ranging age from 20 to 78 years were selected for the evaluation. 52 subjects completed the study. The remaining subjects discontinued their participation for various reasons, none of which were related to the application of the test material.
Positive control results:
N/A
Other effects / acceptance of results:
Observations remained negative throughout the test interval.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.2 g of the test material
No. with + reactions:
0
Total no. in group:
52
Clinical observations:
no skin reactions observed
Remarks on result:
no indication of skin sensitisation
Remarks:
there was no skin reaction in any of the subjects
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0.2 g of the test material
No. with + reactions:
0
Total no. in group:
52
Clinical observations:
no skin reaction observed
Remarks on result:
no indication of skin sensitisation
Remarks:
there was no skin reaction in any of the subjects
Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the test material did not indicate a potential for dermal irritation or allergic contact sensitization.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification