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:
July 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
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
Report date:
2005

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:
yes

Test material

Constituent 1
Reference substance name:
Rye, ext.
EC Number:
290-271-3
EC Name:
Rye, ext.
Cas Number:
90106-48-2
IUPAC Name:
Oligosaccharides and polysaccharides of glucose from Rye
Test material form:
liquid
Details on test material:
BATCH: 5.180.1
Liquid limpid
Color: yellow
Storage Condition: Room temperature

Method

Ethical approval:
confirmed, but no further information available
Details on study design:
Volunteers of the female or male sex from 18 to 65 years of age, with a normal skin , without any dermatological lesion on the experimental area shoul 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:
12 volunteers have been included. The average irritation index is 0

Applicant's summary and conclusion

Conclusions:
The test item can be considered as non irritant after an application with the help of an occlusive patch for 48 h on 12 volunteers.
Executive summary:

In a single patch test, 12 volunteers (men or women) from 28 to 62 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). 12 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.