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Toxicological information

Exposure related observations in humans: other data

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Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Controlled human covered patch test under according to Good Clinical Practice criteria

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Type of study / information:
Type of experience: Human
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline available
Guideline:
other: Human covered patch test
Deviations:
not applicable
GLP compliance:
yes
Remarks:
GCP compliance

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Hostapur SAS
- Physical state: liquid / gel
- Analytical purity: 60%, 30%, 10%
- Composition of test material, percentage of components: 60% Hostapur SAS, water; 30% Hostapur SAS, water; 10% Hostapur SAS, water
- Isomers composition: n.a.
- Purity test date: production sample dated March 2000
- Lot/batch No.: DEADAN 2863
- Expiration date of the lot/batch: April 2002
- Radiochemical purity (if radiolabelling): n.a.
- Specific activity (if radiolabelling): n.a.
- Locations of the label (if radiolabelling): n.a.
- Expiration date of radiochemical substance (if radiolabelling): n.a.
- Stability under test conditions: stable
- Storage condition of test material: room temperature
- Other:

Method

Ethical approval:
confirmed and informed consent free of coercion received
Details on study design:
Human covered patch test using a pilot phase and a subsequent main test phase to ensure safe conditions for volunteers. Pilot and main phase
started with diluted test substance and short exposure periods. Testing with higher concentrations and longer exposure periods in the main testing
phase depended on the results from the pilot phase.
Exposure assessment:
measured
Details on exposure:
TYPE OF EXPOSURE: dermal exposure under semi-occlusive patch test conditions
EXPOSURE LEVELS: 10% Hostapur SAS, 30% Hostapur SAS, 60% Hostapur SAS

EXPOSURE PERIOD: 1 hour up to 4 hours

POSTEXPOSURE PERIOD: 72 hours

DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES: 4 groups of volunteers (3 pilot groups of 3 volunteers, one main group of 10
volunteers. No existing skin problems, no medication at time of testing

Results and discussion

Results:
Based on the results of this study, Hostapur SAS in concentrations up to 60% is not regarded to be a skin irritant in humans.

Applicant's summary and conclusion

Conclusions:
Hostapur SAS up to 60% is not regarded to be a skin irritant in humans
Executive summary:

A human covered patch test was carried out with sec-alkane sulfonate-sodium salts SAS (10%, 30% or 60%) to evaluate potential skin irritation in humans under GCP conditions using a methodology which mimics the standard Draize rabbit skin irritation test. For ethical reasons and to ensure safe test conditions for the volunteers, at first a pilot phase was conducted using diluted sec-alkane sulfonate-sodium salts SAS (10%) and after that sec-alkane sulfonate-sodium salts SAS at 30% and 60% test concentrations. The test materials were applied to the left arm of three volunteers at first for one hour. In every case, only after there were no unacceptable responses or results observed, testing with the higher active product was initiated. Since no significant skin reactions were observed in the pilot phase, a subsequent dermal exposure for 4 hours took place (again first with the 10% sample following the 30% sample). After that sec-alkane sulfonate-sodium salts SAS (60%) was tested under semi-occlusive conditions in 10 human volunteers. The exposure period was 4 hours. After removal of the test patches the treated skin sites were gently wiped with a moist cotton wool ball and than graded one hour later. Further skin readings were made after a further 24, 28 and 72 hours. Throughout the study there was no evidence of oedema or encrustation in any of the pilot or main group subjects. Some of the human volunteers exhibited very slight, but transient erythema. Based on the low irritation levels obtained, sec-alkane sulfonate-sodium salts SAS in concentrations up to 60% active was not regarded to be a skin irritant in humans even under conditions comparable to animal experiments