Registration Dossier

Toxicological information

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
key study
Study period:
9 - 12 Feb 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Type of study / information:
Skin irritation - human information (Occlusive Patch Test)
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline required
GLP compliance:
yes
Remarks:
GCP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: fluid gel, not further specified

Method

Ethical approval:
other: informed consent statement received and signed
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: aluminium caps of 8 mm in diameter and of 20 µL in volume. Each cup represented about 50 mm² area. They were affixed by two on an adhesive tape.
- Vehicle / solvent: destilled water
- Concentrations: 10% (a.i.)
- Volume applied: 20 µL per patch
- Testing/scoring schedule: exposure for 24 h; scoring 24 and 48 h after application
- Removal of test substance: immediately after patch removal

EXAMINATIONS
- Grading/Scoring system: Scoring was performed for erythema, edema, vesicles, dryness, wrinkling and glazing
Exposure assessment:
not specified
Details on exposure:
TYPE OF EXPOSURE: 11 females and 1 male of Caucasian volunteers were administered to the test material under occlusive conditions (patch test). The patch was applied to the left upper back which had not received any treatment before. A solution of 2% sodium lauryl sulfate was used as a positive control and was applied the same way on a different skin area.

TYPE OF EXPOSURE MEASUREMENT: Exposure pads

EXPOSURE LEVELS: 18.2% (10% a.i.) formulation

EXPOSURE PERIOD: 24 hour

POSTEXPOSURE PERIOD: 30 min and 24 hour

DESCRIPTION / DELINEATION OF EXPOSURE GROUPS: 11 females and 1 male of Caucasian volunteers (18 to 27 years of age)

Results and discussion

Results:
Slight to clear erythema formation was recorded in 11/12 volunteers (grade 1-2), whereas edema formation was only recorded in 4/12 volunteers (grade 1-2) 24 h after application of the positive control. Wrinkling (grade 1) was noted in 1/12 volunteers and neither glazing nor dryness was recorded in any volunteer. 1/12 volunteers did not show any skin reaction when treated with the positive control substance. 48 h after administration of the positive control 11/12 volunteers showed erythema (grade 1-2), 2/12 edema (grade 1) and 7/12 wrinkling (grade 1-2). No vesicles, glazing and dryness were detected. Volunteers treated with the vehicle (distilled water) did not show edema, vesicles wrinkling, glazing and dryness, neither 24 nor 48 h after application. 1/12 volunteers showed slight erythema formation (grade 1) 24 h after application which was fully reversible within 48 hours. Due to their reaction to the application of controls, two volunteers were excluded from the study. 9/10 volunteers did not show any skin reaction when treated with the test material neither 24 nor 48 hours after application. Slight erythema and wrinkling (grade 1) was present in only 1/10 volunteers 24 h after application with the test material. The erythema was still present after 48 h, whereas wrinkling was fully reversible at this time point. In summary, the test material is considered not to be irritating to human skin under the experimental conditions when applied as 18.2% (10% a.i.) formulation.

Applicant's summary and conclusion

Conclusions:
Under the experimental conditions the test material appeared not to be irritating to skin when applied as a 18.2% (10% a.i.) formulation.