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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to good scientific methodology and to the procedures and protocols as outlined in the Federal Register Vol. 46, No. 17 (January 27, 1981).
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in Section 13.
Cross-reference
Reason / purpose:
read-across: supporting information
Reference
Endpoint:
sensitisation data (humans)
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to good scientific methodology and to the procedures and protocols as outlined in the Federal Register Vol. 46, No. 17 (January 27, 1981).
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in Section 13.
Reason / purpose:
read-across source
Type of sensitisation studied:
skin
Study type:
study with volunteers
Qualifier:
according to
Guideline:
other: Study conducted according to the procedures and protocols outlined in the Federal Register Vol. 46, No. 17 (January 27,1981).
Deviations:
not specified
GLP compliance:
no
Type of population:
general
Ethical approval:
not specified
Subjects:
Two hundred twenty-two (222) subjects, male and female, ranging in age from 18 to 75 years, started the study; two hundred two (202) subjects completed this study. The twenty subjects who discontinued the study did so for reasons unrelated to the test substance.
Clinical history:
No data
Controls:
No
Route of administration:
dermal
Details on study design:
Subjects (n = 202) were exposed (skin on the back, under occlusion) three times a week for three weeks (Days 1, 3, and 5). The patches removed 24 hours later. Test sites were examined for irritation prior to application on Days 3, 5 and Day 1 of the following week. Following a 2 week rest period, subjects were challenged with the test substance on both the original site and a naïve site (volar forearm). The sites were evaluated at 24 and 48 hours post-application to assess sensitization potential.
Results of examinations:
No effects related to the test substance were observed for any individual either during the three week induction period or at challenge for sensitization during Week 6.
Conclusions:
Under conditions of this study, Resin acids and Rosin acids, hydrogenated, esters with glycerol (also known as Foral 85 (X-31733-28)) did not cause irritation and did not elicit evidence of skin sensitization in humans. The test substance presents a low skin sensitization hazard upon skin contact under conditions of normal use. Foral 85 (X-31733-28) is not classified for Skin Sensitization according to the 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, a group of 202 panelists (male and female) were exposed to 0.2 mL of Foral 85 (X-31733-28) under occluded patch. Induction applications were made for 24 hours, 3 times/week for a total of 10 applications. After each 24 hours of exposure, the patches were removed, and 48-72 hours after patch application, the sites were graded for irritation. After a rest period of 2 weeks following the last application, the panelists were patched with the test substance on both the original site and a naïve site (volar forearm) to determine the sensitization potential of the test material. No irritation was seen in any panelist during the induction or the sensitization (challenge) portions of the test. Under the conditions of the study, Foral 85 (X-31733-28) did not demonstrate a potential for dermal irritation and/or sensitization.  

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
according to
Guideline:
other: Study conducted according to the procedures and protocols outlined in the Federal Register Vol. 46, No. 17 (January 27,1981).
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
-Test material (as cited in report): X-31733-28

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
Two hundred twenty-two (222) subjects, male and female, ranging in age from 18 to 75 years, started the study; two hundred two (202) subjects completed this study. The twenty subjects who discontinued the study did so for reasons unrelated to the test substance.
Clinical history:
No data
Controls:
No
Route of administration:
dermal
Details on study design:
Subjects (n = 202) were exposed (skin on the back, under occlusion) three times a week for three weeks (Days 1, 3, and 5). The patches removed 24 hours later. Test sites were examined for irritation prior to application on Days 3, 5 and Day 1 of the following week. Following a 2 week rest period, subjects were challenged with the test substance on both the original site and a naïve site (volar forearm). The sites were evaluated at 24 and 48 hours post-application to assess sensitization potential.

Results and discussion

Results of examinations:
No effects related to the test substance were observed for any individual either during the three week induction period or at challenge for sensitization during Week 6.

Applicant's summary and conclusion

Conclusions:
Under conditions of this study, Resin acids and Rosin acids, hydrogenated, esters with glycerol (also known as Foral 85 (X-31733-28)) did not cause irritation and did not elicit evidence of skin sensitization in humans. The test substance presents a low skin sensitization hazard upon skin contact under conditions of normal use. Foral 85 (X-31733-28) is not classified for Skin Sensitization according to the 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, a group of 202 panelists (male and female) were exposed to 0.2 mL of Foral 85 (X-31733-28) under occluded patch. Induction applications were made for 24 hours, 3 times/week for a total of 10 applications. After each 24 hours of exposure, the patches were removed, and 48-72 hours after patch application, the sites were graded for irritation. After a rest period of 2 weeks following the last application, the panelists were patched with the test substance on both the original site and a naïve site (volar forearm) to determine the sensitization potential of the test material. No irritation was seen in any panelist during the induction or the sensitization (challenge) portions of the test. Under the conditions of the study, Foral 85 (X-31733-28) did not demonstrate a potential for dermal irritation and/or sensitization.