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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to good scientific methodology but no documentation was provided regarding Good Clinical Practices (GCPs).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Test subjects were exposed dermally on the back, under occlusion, three times a week for three weeks. The patches were removed after 23 hr, and skin at the test site assessed for irritation. After a 12 d rest period, a naïve site (adjacent to the induction site) was exposed to the test substance, and any responses present evaluated at 30 to 60 minutes and again at 24 and 48 hours after patch removal to assess sensitization potential.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
-Test material (as cited in study report): Foral AX

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
Fifty-three (53) subjects, 26 Caucasian males ranging in age from 20-61 and 27 Caucasian females ranging in age from 18-67 completed the study.
Clinical history:
No data
Controls:
No data
Route of administration:
dermal
Details on study design:
The study used the “Draize-Shelanski” technique. Test subjects were patched dermally on the back under occlusive patches with 0.2 mL of the test material (a 50% solution of the test substance in corn oil). The patches used were commercial clear plastic patches with a non-woven webril center area. Subjects were patched three times a week for three weeks on Mondays, Wednesdays, and Thursdays. The subjects removed the patches after 23 hours, and scoring of patch sites for irritation was made prior to the next application. The readings for the Wednesday applications were made just prior to the Thursday applications. Dermal reactions, if any, were assessed to determine the primary irritation potential of the test substance. After a rest period of 12 days following the last patch application, the test subjects were dermally patched on a naïve site (adjacent to the induction patch) with the test substance, and the site was evaluated at 30 to 60 minutes and 24 and 48 hours after patch removal in order to assess the sensitization potential of the test material.

Reference:
Draize JH, 1955. Food Drug Cosmetic Law J., 10:722.

Shelanski HA and Shelanski MU, 1953. Prec. Sci. Sect. Toilet Goods Assoc., 20:46.

Results and discussion

Results of examinations:
No effects related to the test substance were observed in any individual during the induction or challenge phases of the study.

Applicant's summary and conclusion

Conclusions:
Under conditions of this study, hydrogenated rosin (Foral AX) was found not to be irritating and did not elicit evidence of skin sensitization in humans when tested in a Human Repeat Insult Patch Test. The test substance presents a low skin sensitization hazard upon skin contact under conditions of normal use. Hydrogenated rosin (Foral AX) is not classified for Skin Sensitization according to UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) or EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Executive summary:

In a human repeat insult patch test, 53 panelists were exposed to Foral AX at 0.2 mL (50% solution in corn oil) under occlusion for three 23 hour periods per week for three weeks. After 23 hours of exposure, the patches were removed, and 23-72 hours after patch application, the sites were graded for irritation. After a rest period of 12 days, the panelists were patched on a naïve site (adjacent to induction patch) with the test substance to determine sensitization potential. No irritation was seen in any panelists during the irritation or the sensitization portion of the test. Under the conditions of the study, Foral AX did not indicate a potential for dermal irritation and/or sensitization.