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Toxicological information

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
Remarks:
Human single patch test using generallyaccepted methods performed according to Good Clinical Practice
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 2010
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 generally-accepted methods performed according to Good Clini cal Practice
Cross-reference
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
skin corrosion: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Reason / purpose for cross-reference:
data waiving: supporting information

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

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:
study has been conducted in the spirit of the good Clinical Practice

Test material

Constituent 1
Reference substance name:
Cassava, ext.
EC Number:
296-251-0
EC Name:
Cassava, ext.
Cas Number:
92456-72-9
IUPAC Name:
Cassava, ext.
Test material form:
solid - liquid: aqueous solution
Details on test material:
Yellow liquid
Specific details on test material used for the study:
Tested diluted at 15% in water

Method

Ethical approval:
confirmed and informed consent free of coercion received
Details on study design:
ADMINISTRATION
- Type of application: occlusive
- Application area: Scapular zones: homolateral (Induction site) and contralateral (challenge site)
- Description of patch: Finn's chamber standard (8 mm) (50 mm²)
Volume applied: 20 μL

The experimental area was the back. The site of application of the product was chosen by the dermatologist or by the technician in charge of the study. Skin appearance was taken into account and the areas of friction with clothes were avoided. Many other products were tested concurrently, so the concerned product was applied by the investigator or the responsible technician, to one of the sites localized by a clockwise distribution, altering of one rank from a subject to another.

The product had to be in contact with skin , under patch, for 48 +/- 5 hours.
The patch removal had to be performed by the investigator or the responsible technician.
The contact time and the modalities of removal, defìned in the protocol, were respected.

The skin examination and joint questioning had to be peformed by the dermatologist or the responsible technician.
This examination had to be performed visually under standard "daylight" source, 15 minutes (or more if some redness appeared after patch removal), after patch removal.
All the examinations were performed in accordance with the conditions defined in the protocol.

The expression of the results of the skin examination and questioning was that defined for this type of study in accordance with the corresponding procedure.
In case of reactivity :
- the main visible signs were noted, i.e. : Erythema, Oedema, Vesicle, Bulla, Papule, Scab, Dryness, Coloration, Soap effect.

The intensity of the erythema and oedema was assessed according to an ordinal scale : absence, very slight, slight moderate, severe.
The appearance of the erythema was specified : diffuse, punctuated, peripheral (around the application site).
The importance of the number of vesicles and papules was assessed according to an ordinal scale : absence, 1 to 2 vesicles or papules, more than 2 vesicles or papules.Bullae, scab, dryness, coloration and soap effect were described,
The impoftance of the dryness and coloration was assessed according to an ordinal scale : absence, very slight, slight, moderate, severe.
the main sensations of discomfolt were described, i.e. : Heating, Stinging, Pruritus (itching).

The results were expressed :
* in percentage of reactive volunteers : for this calculation only the visible signs of reactivity : erythema, oedema, vesicle, bulla, papule, scab, were taken into account.
* in a descriptive manner for the other visible signs or for the sensations of discomfort : if the frequency of appearance of these signs justified it, the percentage of reactive volunteers was calculated.
* in score of skin irritation, calculated from the "marks" allocated to the visible signs : erythema, oedema, vesicle, papule (from I to 2 or 3) and bulla, scab (2 if presence) which took into account the intensity of the skin reactions.
For each volunteer, an individual daily irritation score (Idis) was calculated : sum of all the marks obtained for the observed signs.

For the panel, a mean daily irritation score (Mdis) was calculated according to the formula :
Mdis = E (Idis) / number of volunteers (exploitable data)

All the volunteers included in the study were taken into account to check the skin compatibility of the test product as long as they were submitted at least to one post application examination at the defined time or else.
The interpretation of the results of the skin examination and questioning was that defined for this type of study in accordance with the corresponding procedure,
This interpretation, performed by the investigator, was absolute, The test product could therefore have a very good, good, quite good, moderate or bad skin compatibility.
The possible reaction observed were either reactions of irritation or the revelation of an allergy previously acquired,
Exposure assessment:
measured
Details on exposure:
CF. study design

Results and discussion

Results:
After patch test removal, there is no reactive volunters. the mean daily irritation score Mdis is 0.

Applicant's summary and conclusion

Conclusions:
Under the experimental conditions adopted, the product has a very good skin compatibility.
Executive summary:

Under the experimental conditions adopted, the product has a very good skin compatibility.