Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

Procedure and observations

A group of 200 individuals who qualified were selected from a local population. The test material was applied under occlusion for a series of effective contact periods of two days' duration. On Mondays, the test material was applied. The participants were instructed to contact the laboratory and inform the investigator immediately if any discomfort was felt at the patch site. On Wednesdays, the patches were removed, the contact sites examined, and the reactions, if any, were graded and recorded. If no reactions occurred, the test material was re-applied immediately for another forty-eighthour period. The participants were instructed to call the laboratory on Thursday if any discomfort was felt. On Friday, the covers were removed and the contact sites were again examined and graded. The contact sites were then rested until the following Monday. This cycle was repeated for three more weeks, so that a series of eight fortyeight- hour applications were completed. On the second Monday following the removal of the last series of applications, the test material was applied to the same contact site. The covers were removed on Wednesday, thereby effecting a challenge contact period of forty-eight hours' duration. The contact sites were examined for visible changes which, if present, were graded and recorded. Sites were re-examined twenty-four and forty-eight hours later for delayed reactions. No visible skin changes signifying reaction to injury were

observed in any of the 200 subjects.

Results and discussion

Under the test conditions, the compound tested as a 20% dilution, was not capable of eliciting visible skin changes consistent with the criteria deemed characteristic of a primary irritant, fatiguing agent, or sensitizer.


Migrated from Short description of key information:
An insult patch test in 200 human volunteers was performed to evaluate the skin sensitizing potential of the test material. A 20% solution of the substance was applied to human skin under occlusive conditions for a series of contact periods of two days duration. No visible skin changes signifying reaction to injury were observed in any of the 200 subjects. The substance is therefore not considered to be a skin sensitizer.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin sensitization under Directive 67/548/EEC,as amended for the 30th time in Directive 2008/58/EC.

                               

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008, as amended for the second time in Directive (EC 286/2011).