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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:
1987/01/12 - 1987/03/06
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well-documented study report which meets basic scientific principles.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information
Reference
Endpoint:
sensitisation data (humans)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1987/01/12 - 1987/03/06
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well-documented study report which meets basic scientific principles.
Justification for type of information:
The justification for read across is provided as an attachment in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across source
Results of examinations:
Phase II: Determination of Phototoxicity and Primary Irritancy
-Results: MRD-86-981 did not elicit any effects which could be construed as a characteristic of a phototoxic propensity or of a primary irritant. Skin patches exposed to MRD-86-981 displayed no signs of skin irritation. The dermal irritation scores were 0 for all subjects (26 people), on all days (5days) of exposure to MRD-86-981. A faint erythema (score of 1) was observed in skin patches exposed to MRD-86-981 and UV light for most subjects, however subjects exposed to only UV light displayed a similar erythema (score of 1).

Phase III - Determination of Photocontact and Contact Allergenic Capabilities
-Results: MRD-86-981 showed no evidence of being a photocontact allergen and no evidence of being either a primary irritant or a contact allergen. No erythema was observed during the rechallenge phase of exposure (score of 0 for all subjects).
Conclusions:
Based on these data and results, MRD-86-981 would not be classified as a dermal irritant or as a dermal sensitizer.
Executive summary:

This data is being read across from the source study that tested Hydrocarbons, C10 aromatics, >1% naphthalene based on analogue read across.

MRD-86-981 was evaluated for its ability to cause dermal irritation and sensitization in a 26 person Human Patch Test.  In addition, the ability to induce a phototoxic or photocontact response was determined by comparing irradiated and non-irradiated skin sites. MRD-86-981 was applied to the skin of human volunteers under semi-occlusive dressing.  Dermal examinations occurred after exposures (day 1 and day 2) and at 24-, 48, and 72-hours post exposure.  Dermal irritation and damage was assessed and scored according to a modified Draize scale.  Application to the skin without or in conjunction with UV irradiation did not elicit a sensitizing or photosensitizing response in any of the study participants. 

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:
Clinical human dermal patch study.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydrocarbons, C10, aromatics, >1% naphthalene
EC Number:
919-284-0
Molecular formula:
None available - not a single isomer - see remarks
IUPAC Name:
Hydrocarbons, C10, aromatics, >1% naphthalene
Details on test material:
- Name of test material (as cited in study report): MRD-86-981
- Physical state: Clear liquid
- Analytical purity: assumed to be 100%
- Lot/batch No.: 1
- Storage condition of test material: Room temperature

Method

Type of population:
general
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 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/suppress 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 I: 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 10cm from the exposure site. Sites were examined 18 and 24 hours.

Phase II: Determination of Phototoxicity 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 0.3g of a 50% w/w MRD-86-981 solution applied to it and held in contact with the skin for 24 hours under a semi-occlusive dressing. Day 2: After 24 hours, participants returned and had 0.3 ml of a neat solution of MRD-86-981 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 hours 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 with the evaluation of photocontact allergenic propensities were performed on the right side. 0.3g of a 30% w/w MRD-86-981 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-86-981 did not elicit any effects which could be construed as a characteristic of a phototoxic propensity or of a primary irritant. Skin patches exposed to MRD-86-981 displayed no signs of skin irritation. The dermal irritation scores were 0 for all subjects (26 people), on all days (5days) of exposure to MRD-86-981. A faint erythema (score of 1) was observed in skin patches exposed to MRD-86-981 and UV light for most subjects, however subjects exposed to only UV light displayed a similar erythema (score of 1).

Phase III - Determination of Photocontact and Contact Allergenic Capabilities
-Results: MRD-86-981 showed no evidence of being a photocontact allergen and no evidence of being either a primary irritant or a contact allergen. No erythema was observed during the rechallenge phase of exposure (score of 0 for all subjects).

Applicant's summary and conclusion

Conclusions:
Based on these data and results, MRD-86-981 would not be classified as a dermal irritant or as a dermal sensitizer.
Executive summary:

MRD-86-981 was evaluated for its ability to cause dermal irritation and sensitization in a 26 person Human Patch Test.  In addition, the ability to induce a phototoxic or photocontact response was determined by comparing irradiated and non-irradiated skin sites. MRD-86-981 was applied to the skin of human volunteers under semi-occlusive dressing.  Dermal examinations occurred after exposures (day 1 and day 2) and at 24-, 48, and 72-hours post exposure.  Dermal irritation and damage was assessed and scored according to a modified Draize scale.  Application to the skin without or in conjunction with UV irradiation did not elicit a sensitizing or photosensitizing response in any of the study participants.