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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:
1991/22/07 - 1991/09/13
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: According to 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:
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:
1991/22/07 - 1991/09/13
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: According to 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.
Reason / purpose:
read-across source
Type of sensitisation studied:
skin
Study type:
study with volunteers
Qualifier:
equivalent or similar to
Guideline:
other: semi-occlusive conditions; Draize Patch Test using a semi-open Parke Davis with Webril pad system
GLP compliance:
yes
Type of population:
general
Ethical approval:
confirmed, but no further information available
Subjects:
139 subjects entered the study and 118 completed the study. 21 subjects withdrew for reasons unrelated to the study. All exposures were 24 hour dermal contact applied under semi-occlusive patches applied to sites on the upper arm.
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 3 months.
Controls:
Controls were performed. Mineral Oil.
Route of administration:
dermal
Details on study design:
Determination of Primary Irritancy and Contact Sensitization Capabilities
-Design: Induction applications were made to the left or right arm (0.1 ml MRD-91-972, neat) for a total of 9 applications over 3 successive weeks (3/week). Applications were held in place via a semi-occlusive patch for 24 hours. A 10 to 15 day rest period followed the last induction application. Challenge applications consisted of a single, 24 hour contact period applied to an adjacent naive site using 0.1 ml MRD-91-972, neat. If a rechallenge was warranted, a site on the lower back using 0.05 ml 10% v/v MRD-91-972 (mineral oil as dilutant) was utilized. Twenty-nine participants were asked to participate in a rechallenge study.

-Evaluation: Reactions were scored 24 and 48 hours after patch removal for each induction phase dose and were graded using the Daize scale. Patients were evaluated 48 and 96 hours after the challenge dose was first administered.
Results of examinations:
Primary Irritation and Sensitization: Sixty-one subjects exhibited strong cutaneous reactions consisting of strong erythema/edema, papules, and vesicular responses to test substance MRD-91-972 at the first induction evaluation. The evaluation of this sample was discontinued on July 26, 1991 by the Test Operations Supervisor and the Investigator due to this strong reaction.
Conclusions:
The overall response patterns (induction, challenge, and rechallenge) indicate that MRD-91-972 are consistent with a severe clinical irritant.
Executive summary:

This study was conducted to determine the potential of MRD-91-972 to cause dermal irritation and sensitization in humans. 118 humans were exposed to MRD-91-972. Induction applications (0.1 ml MRD-91-972, neat) were made to the arm for 24 hours under a semi-occlusive patch. Sixty-one subjects exhibited strong cutaneous reactions consisting of strong erythema/edema, papules, and vesicular responses to test substance MRD-91-972 at the first induction evaluation. The evaluation of this sample was discontinued on July 26, 1991 by the Test Operations Supervisor and the Investigator due to this strong reaction. The overall response patterns (induction, challenge, and rechallenge) indicate that MRD-91-972 are consistent with a severe clinical irritant.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: semi-occlusive conditions; Draize Patch Test using a semi-open Parke Davis with Webril pad system
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
general
Ethical approval:
confirmed, but no further information available
Subjects:
139 subjects entered the study and 118 completed the study. 21 subjects withdrew for reasons unrelated to the study. All exposures were 24 hour dermal contact applied under semi-occlusive patches applied to sites on the upper arm.
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 3 months.
Controls:
Controls were performed. Mineral Oil.
Route of administration:
dermal
Details on study design:
Determination of Primary Irritancy and Contact Sensitization Capabilities
-Design: Induction applications were made to the left or right arm (0.1 ml MRD-91-972, neat) for a total of 9 applications over 3 successive weeks (3/week). Applications were held in place via a semi-occlusive patch for 24 hours. A 10 to 15 day rest period followed the last induction application. Challenge applications consisted of a single, 24 hour contact period applied to an adjacent naive site using 0.1 ml MRD-91-972, neat. If a rechallenge was warranted, a site on the lower back using 0.05 ml 10% v/v MRD-91-972 (mineral oil as dilutant) was utilized. Twenty-nine participants were asked to participate in a rechallenge study.

-Evaluation: Reactions were scored 24 and 48 hours after patch removal for each induction phase dose and were graded using the Daize scale. Patients were evaluated 48 and 96 hours after the challenge dose was first administered.

Results and discussion

Results of examinations:
Primary Irritation and Sensitization: Sixty-one subjects exhibited strong cutaneous reactions consisting of strong erythema/edema, papules, and vesicular responses to test substance MRD-91-972 at the first induction evaluation. The evaluation of this sample was discontinued on July 26, 1991 by the Test Operations Supervisor and the Investigator due to this strong reaction.

Applicant's summary and conclusion

Conclusions:
The overall response patterns (induction, challenge, and rechallenge) indicate that MRD-91-972 are consistent with a severe clinical irritant.
Executive summary:

This study was conducted to determine the potential of MRD-91-972 to cause dermal irritation and sensitization in humans. 118 humans were exposed to MRD-91-972. Induction applications (0.1 ml MRD-91-972, neat) were made to the arm for 24 hours under a semi-occlusive patch. Sixty-one subjects exhibited strong cutaneous reactions consisting of strong erythema/edema, papules, and vesicular responses to test substance MRD-91-972 at the first induction evaluation. The evaluation of this sample was discontinued on July 26, 1991 by the Test Operations Supervisor and the Investigator due to this strong reaction. The overall response patterns (induction, challenge, and rechallenge) indicate that MRD-91-972 are consistent with a severe clinical irritant.