Registration Dossier

Administrative data

Description of key information

In two patch tests conducted with human volunteers in which the test material was applied to the skin in a preparation at low concentrations in Vaseline no signs of irritancy were observed.

Additional information

Two supporting studies are provided. Neither were conducted to any recognised guideline. The methods are explained in very brief detail within the report and important information such as the demographics and the medical history of the volunteers, which is critical to the validity of the results, were lacking. Neither the batch details nor the purity of the substance are reported and the tests are described as being conducted using a preparation.

 

In the first supporting study, the substance was applied as a 5 % preparation in Vaseline. Concurrent vehicle controls were run during the study. The results are presented in table form with simple “positive/negative” descriptions of any reaction without being qualified. The subjects were exposed to the test material for 48 hours using an occluded patch. None of the volunteers of the study exhibited a positive reaction to the test material.

 

As the substance was not tested up to a concentration approaching full strength, it cannot be considered as reliable for assessing the irritancy potential of the substance. As such the study was awarded a reliability score of 3 in accordance with the criteria of Klimisch (1997).

 

 

In the second supporting study, the test material was applied in Vaseline in concentrations of 5, 2 and 1 %. The results are presented but the criteria for scoring the results are not defined. 

The subjects were exposed to the test material for 24 hours using an occluded patch. All except one of the volunteers of the study exhibited negative reactions to the test material. The only positive reaction was one male with slight erythema; this was not considered to be related to the irritation potential of the test material. Under the conditions of the test, the test material was found to be non-irritating.

As the substance was not tested up to a concentration approaching full strength it cannot be considered as reliable for assessing the irritancy potential of the substance. As such the study was awarded a reliability score of 3 in accordance with the criteria of Klimisch (1997).