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:

Three skin sensitisation studies have also been conducted in humans, as follows:

- Clinical Research Laboratories, Inc (2012) Repeated insult patch test with re-challenge test

One hundred fourteen subjects participated in evaluating the potential of the test item to elicit dermal irritation and/or induce sensitization. The test material was applied under an occlusive patch to the upper back of each subject and was allowed to remain in direct skin contact for a period of 24 h. Patches were applied to the same site on Monday, Wednesday, and Friday for a total of 9 applications during the Induction Period. The sites were graded for dermal irritation 24 h after removal of the patches by the subjects on Tuesday and Thursday and 48 h after removal of the patches on Saturday. Following approximately a 2-week rest period, challenge patches were applied to previously untreated test sites on the back. After 24 h, the patches were removed and the test sites were evaluated for dermal reactions. The test sites were re-evaluated at 48 and 72 h. Subjects exhibiting reactions during the Challenge Phase of the study may have been asked to return for a 96-hour reading. One hundred four subjects completed the study. One subject (#30) participated in a Re-Challenge Test approximately 4 weeks after the conclusion of the RIPT, due to observed reactions during the Challenge Phase. However the reactions were not confirmed during the Re-Challenge Test for subject #30. In conclusion, the test material did not demonstrate a potential for eliciting dermal irritation or inducing sensitization under the following test conditions: 0.2mL of the test material applied to a 3.63 cm2occlusive patch.

- Epstein (1974) To determine the contact sensitizing potential of: Group VII- 1974, 74-10-59 Cis-3-hexenyl acetate

Twenty two subjects participated in a study to determine the sensitising potential of the test item. The test material was applied under occlusion to the same sites on the volar aspect of the forearms of all subjects for 5 alternate day 48 h periods. Following a 10-14 d rest period, challenge patches were applied to fresh sites for 48 h. The challenge sites were read on removal of the patch 24 h later and in some instances 96 h later. The test item produced no reactions that were considered allergic in the 22 subjects tested.

- Rubenkoenig and Ede (1965) Repeated insult patch test of SC-1167V

Forty three subjects participated in a study to determine the sensitising potential of the test item using an adaptation of the repeated insult patch test. The study comprised a series of nine 24-h exposures on a Monday-Wednesday-Friday sequence for 3 successive weeks, the reaction to each exposure being scored at the session following and the reaction to the ninth application on Monday of the fourth week. The test patch was applied to the same site each time, unless reaction to sample or tape adhesive rendered this inadvisable, in which case the test patch was either omitted or applied to a fresh site. On Monday of the sixth week a challenge patch was applied to a site not previously exposed, and removed after 24 h. Reactions to challenge were scored on Wednesday and Friday of the sixth week. Thirty eight subjects completed the program. Under the conditions of this study the test substance caused no primary irritation. None of the 38 subjects tested were sensitised by the sample of the test substance.

The Clinical Research Laboratories, Inc (2012) study has been conducted in accordance with Good Clinical Practice using a modified Shelanski - Shelanski human patch test method and is well documented. As such, the study has been assigned a reliability 1. The Rubenkoenig & Ede (1965) and Epstein (1974) studies have been conducted using a method which is comparable to a repeated insult patch method, meets generally accepted scientific standards and are adequately reported and have been assigned a reliability 2. Therefore, when the results of these studies are reviewed collectively they are considered acceptable for classification.


Migrated from Short description of key information:
Clinical Research Laboratories, Inc (2012) Repeated insult patch test with re-challenge test: Based on a test population of 104 subjects, the test material did not demonstrate a potential for eliciting dermal irritation or inducing sensitization under the test conditions the test material did not demonstrate a potential for eliciting dermal irritation or inducing sensitization.

Epstein (1974) To determine the contact sensitizing potential of: Group VII- 1974, 74-10-59 Cis-3-hexenyl acetate: The test item produced no reactions that were considered allergic in the 22 subjects tested

Rubenkoenig and Ede (1965) Repeated insult patch test of SC-1167V: None of the 38 subjects tested were sensitised by the sample of the test substance

Justification for selection of skin sensitisation endpoint:
The Clinical Research Laboratories, Inc (2012) study has been conducted to Good Clinical Practice and a recognised guideline study and is well documented and has been assigned a reliability 1. The Epstein (1974) and Rubenkoenig & Ede (1965) studies have been conducted to a method comparable to a guideline, are well documented and have been assigned a reliability 2.

Justification for classification or non-classification

One of the available human studies has been assigned a reliability 1 and two of the available human studies have been assigned a reliability 2. When the results of these studies are reviewed collectively they are considered acceptable for classification. The test material was found to be a non-sensitiser in human volunteers and therefore can be considered to be non-classified.