Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987/01/12-1987/03/06
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to guidelines/standards.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Dermal examinations occurred after exposures (day 1 and day 2) and then at 24, 48, and 72 hrs post exposure. Dermal irritation and damage was assessed and scored according to a modified Draize scale.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Ethical approval:
confirmed, but no further information available
Subjects:
Panel no.: 87-6: 26 participants completed the study
Clinical history:
A past/present medical history was obtained and a brief physical was performed for each individual. Candidates were excluded for any one of the following reasons: systemic illness which might have contra-indicated participation, skin disease, medication which might augment/supress effects of test material, participation in another sensitization study within the past 10 weeks.
Controls:
Controls were performed.
Route of administration:
dermal
Details on study design:
Phase 1: Determination of MED (Minimum Erythemogenic Dose - UVB light produced Erythemogenic Effects)
- Design: 5 sites on the back and 5 sites on the arm were exposed to UVB light for either 10, 20, 30, 40, or 50 seconds at 10 cm from the exposure site. Sites were examined at 18 and 24 hrs.

Phase II: Determination of Phototoxicty and Primary Irritancy
- Design: On each arm, 4 test sites were used with a 5th site serving as a control (no test material applied). Day 1: each testing site had 0.3 g of a 50% w/w MRD-86-823 solution applied to it and held in contact with the skin for 24 hrs under a semi-occlusive dressing. Day 2: After 24 hrs, participants returned and had 0.3 ml of a neat solution of MRD-86-823 applied to the same sites. The right arm was exposed to UVA (phototoxicity) and the left arm was not (primary irritant study), both arms were examined for irritation. Participants returned at 24, 48, and 72 hrs for an examination for dermal irritation.

Phase III - Determination of Photocontact and Contact Allergenic Capabilities
- Design: On each side of the back, 9 test sites were used for experimental purposes with a 10th site serving as a control (no test material applied). The left side of the back was used to evaluate the irritant and contact allergenic propensities while the evaluation of photocontact allergenic propensities was performed on the right side. 0.3 g of a 30% w/w MRD-86-823 solution was used at each experimental site for the evaluation of the propensities.

Results and discussion

Results of examinations:
Phase II: Determination of Phototoxicity and Primary Irritancy
-Results: MRD-86 -823 did not elicit any effects which could be construed as a characteristic of a phototoxic propensity or of a primary irritant.

Phase III: Determination of Photocontact and Contact Allergenic Capabilities
-Results: MRD-86-823 showed no evidence of being a photocontact allergen and no evidence of being either a primary irritant or a contact allergen.

Applicant's summary and conclusion

Conclusions:
Based on these data and results, MRD-86-823 would not be classified as dermal irritant or as a dermal sensitizer.


Executive summary:

This study was conducted to determine the potential of MRD-86 -823 to cause dermal irritation and sensitization in humans with or without UV irradiation. 26 humans were exposed to MRD-86 -823. Dermal examinations occurred after exposures (day 1 and day 2) and then at 24, 48, and 72 hrs post exposure. Dermal irritation and damage was assessed and scored according to a modified Draize scale. The most severe reaction noted in all experimental paradigms was noted as a "1" or slight erythema. MRD-86 -823 did not elicit any effects which could be construed as a characteristic of a phototoxic propensity or of a primary irritant. MRD-86 -823 showed no evidence of being a photocontact allergen and no evidence of being either a primary irritant or a contact allergen. Based on these data and results, MRD-86 -823 would not be classified as dermal irritant or as a dermal sensitizer.