D-Glucopyranose, oligomeric, decyl octyl glycosides, 2-hydroxy-3-sulfopropyl ethers, sodium salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Remarks:

Human Patch test survey

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: 48 Hours Patch Test

Deviations:

not specified

Principles of method if other than guideline:

Determination by epidermal contact the primary irritation potential of a test material

GLP compliance:

no

Remarks:

These studies have been performed with adherence to ICH Guideline E6 for Good Clinical Practice and requirements provided for in 21 CFR parts 50 and 56 and in accordance to standard operating procedures and applicable protocols

Test material

Test material information

Constituent 1

Reference substance name:

D-Glucopyranose, oligomeric, decyl octyl glycosides, 2-hydroxy-3-sulfopropyl ethers, sodium salts

EC Number:

830-086-2

Cas Number:

742087-48-5

Molecular formula:

Substance is a UVCB - variable composition

IUPAC Name:

D-Glucopyranose, oligomeric, decyl octyl glycosides, 2-hydroxy-3-sulfopropyl ethers, sodium salts

Test material form:

liquid

Specific details on test material used for the study:

Prior to the initiation of this study, the test material was prepared as a 10% dilution, using distilled water

Test animals

Species:

human

Strain:

other: male / female

Details on test animals or test system and environmental conditions:

Fifty-three (53) subjects, male and female, ranging in age from 16 to 79 years, who qualified were selected for this evaluation. All (53) subjects completed this study.
The following criteria were used;
a. Male and female subjects, age I 6 and over.
b. Absence of any visible skin disease which might be confused with a skin reaction from the test material.
c. Prohibition of use of topical or systemic steroids and/or antihistamines for at least seven days prior to study initiation.
d. Completion of a Medical History form and the understanding and signing of an Informed Consent form.
e. Considered reliable and capable of following directions

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: The upper back between the scapulae served as the treatment area. No specific preparation of the skin was detailed

Vehicle:

water

Remarks:

10% dilution in distillated water

Controls:

yes

Amount / concentration applied:

Approximately 0.2 ml of the test material, or an amount sufficient to cover the contact surface, was applied to the l " x l" absorbent pad portion of a clear adhesive dressing*. When secured to the appropriate treatment site, this dressing formed a semi-occlusive patch.
The test material remained in contact with the skin for a total of forty-eight hours. This site was then evaluated for gross changes. Absence of any visible skin change was assigned a zero value. The test site was reevaluated at seventy-two hours.

Duration of treatment / exposure:

48 hours

Observation period:

48 hours and 72 hours

Number of animals:

53 subjects

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

based on visible skin reaction

Basis:

mean

Remarks:

53 human subjects

Time point:

other: 48/72 hr

Score:

0

Max. score:

0

Reversibility:

other: no data

Remarks:

no effect seen so no reversibility required

Remarks on result:

no indication of irritation

Remarks:

Observations were carried out after 2 and 3 days

Results 2

Irritation parameter:

edema score

Remarks:

based on visible skin reaction

Basis:

mean

Remarks:

53 human subjects

Time point:

other: 48/72 hours

Score:

0

Max. score:

0

Reversibility:

other: not applicable. No effect seen so no reversblity required

Remarks on result:

no indication of irritation

Remarks:

Observation taken 2 and 3 days after application

Irritant / corrosive response data:

The test material remained in contact with the skin for a total of forty-eight hours. This site was then evaluated for gross changes. Absence of any visible skin change was assigned a zero value - see scoring system below. The test site was re-evaluated at seventy-two hours.

Any other information on results incl. tables

The scoring system that was applied used the following descriptions

0: Barely perceptible or spotty erythema

1: Mild erythema covering most of the test site

2: Moderate erythema, possible presence of mild edema

3: Marked erythema, possible edema

4: Severe erythema, possible edema, vesiculation, bullae and/or ulceration

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No visible skin reaction.