Ricinoleyl monomaleate triglyceride

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 27 to March 12, 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented GLP study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Repeated Insult Patch test according to an internal protocol as outlined in the Fedral Register vol. 46, no. 17, 1981.

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

not specified

Details on test material:

No data

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

- Number of subjects exposed: initially 114, 107 completed the study
- Sex: male and female
- Age: 6 to 79 years
- Race: not indicated

Clinical history:

- History of allergy or casuistics for study subject or populations: excluded
- Symptoms, onset and progress of the disease: absence of any visible skin desease
- Exposure history: no use of topical or systemic steroids or antihystamines seven days prior to the start of the test
- Aggravating factors both in home and workplace: None defined
- Family history: Not defined
- Medical history (for respiratory hypersensitivity): Not relevant
- Any other allergic or airway disorders: If present, not included

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Description of patch: 3/4"x 3/4"absorbent pad portion of an adhesive dressing
- Concentrations: 100%
- Volume applied: 0.2 g
- Dermal dosage: 55 mg/cm2
- Induction period: Patches applied three times a week for a total of nine applications
- Challenge phase: Approx. 2 weeks after the final Induction patch application, a challenge patch was applied to a virgin test siteadjecent to the original patch site and after removal scored for reaction after 24 and 72 h.

EXAMINATIONS
- Grading/Scoring system:
0= No visible skin reaction
+= Barely perceptible or spotty erythema
1= Mild erythema
2= Moderate erythema + possible mild edema
3= Marked erythema + possible edema
4= Severe erythema, possible edema, vesiculation, bullae and/or ulceration

Results and discussion

Results of examinations:

RESULT OF CASE REPORT: Observations remained completely negative for all participants throughout the test interval.

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study, Ceraphyl MTE did not indicate a potential for dermal irritation or allergic contact sensitization at a dermal dose of 55 mg/cm2.