Saccharides of mannose and galactose from Ceratonia Siliqua seed

Exposure related observations in humans: other data

Administrative data

Endpoint:

exposure-related observations in humans: other data

Remarks:

Human single patch test using generally accepted methods performed according to Good Clinical Practice

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Remarks:

Human single patch test using generallyaccepted methods performed according to Good Clinic al Practice

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

Adequate data from a clinical study on volunteers show the substance is not irritation for the skin. See end-point 7.10.5

Reason / purpose for cross-reference:

data waiving: supporting information

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Type of study / information:

Acute skin tolerance on volunteers

Endpoint addressed:

skin irritation / corrosion

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Skin irritation potential of the test item was studied in volunteers using 48 hour single patch test and skin reactions were evaluated.

GLP compliance:

no

Remarks:

Good Clinical Practices

Test material

Test material information

Constituent 1

Reference substance name:

Saccharides of mannose and galactose from Ceratonia Siliqua seed

IUPAC Name:

Saccharides of mannose and galactose from Ceratonia Siliqua seed

Test material form:

liquid

Details on test material:

BATCH: 08 077 1
Liquid limpid
Color: clear yellow
Storage Condition: Room temperature

Specific details on test material used for the study:

Tested diluted at 15%

Method

Ethical approval:

confirmed, but no further information available

Details on study design:

11 Volunteers of the female or male sex from 27 to 61 years of age, with a normal skin , without any dermatological lesion on the experimental area should be included in the study

Exposure assessment:

measured

Details on exposure:

Single application of 0.02 mL of the studied test item, on the external face of the arm, maintained for 48 h in contact with the skin, with the help of an occlusive patch (Haye's-Chambers).

Results and discussion

Results:

11 volunteers have been included. The average irritation index is 0.

Applicant's summary and conclusion

Executive summary:

In a single patch test, 11 volunteers from 21 to 61 years of age, with a normal skin, without any dermatological lesion on the experimental area, have been included in the study. Single

application of 0.02 mL of the test item, on the external face of the arm, maintained for 48 h in contact with the skin, with the help of an occlusive patch (Haye's-Chambers).

11 volunteers have been included and were analyzed. The average irritation index is 0.

Under the conditions employed in this study, test item was considered as non-irritant.