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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
Study period:
52 days (in-life: Jan 26, 1998 to March 19, 1998)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted according to Good Clinical Practices and generally accepted international methods for the testing of skin sensitization potential in humans. Study was monitored by Quality Assurance. Limited data present, however, on the test substance.
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
Study period:
52 days (in-life: Jan 26, 1998 to March 19, 1998)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted according to Good Clinical Practices and generally accepted international methods for the testing of skin sensitization potential in humans. Study was monitored by Quality Assurance. Limited data present, however, on the test substance.
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
Results of examinations:
For all subjects completing the study, all dermal reactions during the induction phase examinations and at the two challenge examinations were recorded as Grade 0 (no visible skin reaction).
Conclusions:
Under conditions of this study, Resin acids and Rosin acids, hydrogenated, Me esters was found not to be irritating and did not elicit evidence of skin sensitization in humans when tested using a test procedure similar to the Modified Draize Procedure. The test substance presents a low skin sensitization hazard upon skin contact under conditions of normal use. Scores were insufficient to classify Resin acids and Rosin acids, hydrogenated, Me esters 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:

This data is being read across from the source study that tested Resin acids and Rosin acids, hydrogenated, methyl esters based on category read across that is explained in the category justification document attached in Section 13 of the dossier.

In a human repeated insult patch test (similar to Modified Draize Procedure), a group of two hundred nine subjects (males and females) above the age of 16 were repeatedly exposed to 0.2 gram of Resin acids and Rosin acids, hydrogenated, Me esters using occluded patches applied to the skin. Induction applications were made 3 times/week for 3 successive weeks. No skin responses were evident during the induction phase of the study. A two-week rest period followed the final induction application. Following the rest period, a challenge application of the test substance (0.2 gram) was made to each subject. During the challenge application, the test substance remained in contact with the skin (at a naïve site) for a period of approximately 24 hours. Observations of the challenge sites were conducted at 24 and 72 hours post application. No dermal responses were noted at the challenge sites during the two examinations. Under the conditions of this study, Resin acids and Rosin acids, hydrogenated, Me esters did not cause a skin sensitization reaction in humans.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: Procedure similar to Modified Draize Procedure. Study performed in accordance with standard operating procedures, study protocol, and government regulations regarding such procedures and protocols outlined in Federal Register (Vol. 46, No.17, 1981-01-27).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
-Identity (according to study report): Hercolyn D
-Batch No.: X-31863-13

No other data on test material.

Method

Type of population:
general
Ethical approval:
confirmed, but no further information available
Subjects:
Two hundred twenty-two qualified subjects, male and female, ranging in age from 17 to 77 years, were selected for the study. Two hundred nine subjects completed all phases of the study. The remaining subjects discontinued their participation for various reasons. None of the reasons were related to the application of the test substance.
Clinical history:
Inclusion Criteria:
-Male and female subjects over the age of 16 years
-Parental or guardian consent available if needed
-Absence of any visible skin disease which might be confused with a skin reaction caused by the test substance
-No use of topical or systemic steroids and/or antihistamines for at least 7 days prior to study initiation
-Completion of a medical history form
-Understanding and signing an informed consent form
-Considered reliable and capable of following directions

Exclusion Criteria:
-Ill health
-Under a doctor's care or taking medication(s) which could influence the outcome of the study
-Females that are pregnant or nursing
-History of adverse reactions to cosmetic or other personal care products
Controls:
Controls were not used in this study. Skin reactions at the application sites were evaluated by comparison to naïve skin.
Route of administration:
dermal
Details on study design:
EXPOSURE:
The upper back between the scapulae served as the treatment area. For all exposures to the test substance, approximately 0.2 gram of the test substance was applied to a 3/4 x 3/4 inch absorbent pad portion of an adhesive dressing. The dressing was then applied to the appropriate treatment site to form an occlusive patch.

INDUCTION PHASE:
Patches were applied 3 times/week (Monday, Wednesday, and Friday) for a total of 9 applications. Treatment sites were marked to ensure the continuity of patch application. Each exposure to the test substance was for a period of 24 hours. Following supervised removal and scoring of the first induction patch, subjects were instructed to remove all future induction patches at home. The evaluation of each test site was made again just prior to re-application of the test substance. Rest periods consisted of 24 hours following each Tuesday and Thursday removal, and 48 hours following each Saturday removal.

CHALLENGE PHASE:
Approximately 2 weeks after the final induction application, a challenge patch was applied to a virgin test site adjacent to the original induction patch site, following the same procedure described for induction. After a 24-hour exposure, the patch was removed. The challenge application site was scored 24 and 72 hours post-application.

SCORING DERMAL REACTIONS:
0 = No visible skin reaction
+ = Barely perceptible or spotty erythema
1 = Mild erythema covering most of the test site
2 = Moderate erythema, possible presence of mild edema
3 = Marked erythema, possible edema
4 = Severe erythema, possible edema, vesiculation, bullae and/or ulceration

Results and discussion

Results of examinations:
For all subjects completing the study, all dermal reactions during the induction phase examinations and at the two challenge examinations were recorded as Grade 0 (no visible skin reaction).

Applicant's summary and conclusion

Conclusions:
Under conditions of this study, Resin acids and Rosin acids, hydrogenated, Me esters was found not to be irritating and did not elicit evidence of skin sensitization in humans when tested using a test procedure similar to the Modified Draize Procedure. The test substance presents a low skin sensitization hazard upon skin contact under conditions of normal use. Scores were insufficient to classify Resin acids and Rosin acids, hydrogenated, Me esters 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 repeated insult patch test (similar to Modified Draize Procedure), a group of two hundred nine subjects (males and females) above the age of 16 were repeatedly exposed to 0.2 gram of Resin acids and Rosin acids, hydrogenated, Me esters using occluded patches applied to the skin. Induction applications were made 3 times/week for 3 successive weeks. No skin responses were evident during the induction phase of the study. A two-week rest period followed the final induction application. Following the rest period, a challenge application of the test substance (0.2 gram) was made to each subject. During the challenge application, the test substance remained in contact with the skin (at a naïve site) for a period of approximately 24 hours. Observations of the challenge sites were conducted at 24 and 72 hours post application. No dermal responses were noted at the challenge sites during the two examinations. Under the conditions of this study, Resin acids and Rosin acids, hydrogenated, Me esters did not cause a skin sensitization reaction in humans.