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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22/05/2018 - 30/06/2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Human Repeated Insult Patch Test (HRIPT)
Version / remarks:
The methodology used by the laboratory is an adaptation from that described by Marzulli and Maibach Human 'Repeated Insult Patch Test for delayed contact hypersensitivity: Marzulli F.N., Maibach H.I., Contact allergy : predictive testing in man, Contact Dermatitis, '1976, 2, pp. 1 -17.
GLP compliance:
yes
Type of study:
patch test
Justification for non-LLNA method:
No laboratory animal studies are available, but human experience indicates upsalite is not a skin sensitiser.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
They have different version of synthesis based on scale (small, medium, large) There is differences between dirrerent scales are related to materials physical properties.
Specific details on test material used for the study:
Lot:Q0002-1701

In vivo test system

Test animals

Species:
other: human
Sex:
male/female
Details on test animals and environmental conditions:
The equipment used for the occluded patch is composed of a small plastic cavity of 0.64 cm 2 with a filter tissue at the bottom which is made to receive the product to test. All this is fixed to a hypoallergenic non woven adhesive tape.

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
not specified
Concentration / amount:
The amount of test material applied to each patch 0.02ml
Day(s)/duration:
9 times on the same site over a period of 3 consecutive weeks
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
not specified
Concentration / amount:
0,02ml
Day(s)/duration:
a single application
No. of animals per dose:
50 volunteers
Details on study design:
A skin examination of the application site is performed by the dermatologist before the 1st product application of the
induction phase, after each patch removal, the application of the challenge and its removal.The area on which the patch is applied is previously cleaned up with demineralised water and dried with cellulose cotton wool tissue.
The patches are put on the back of the volunteer.

Treatment sites are assessed before the first application of test material (baseline) and after treatment at 30 minutes
after patch removal during the induction period.
After a rest period of 2 weeks a patch was applied on a previously unpatched and patched skin site. This site was evaluated
on 30 minutes, 24, 48, 72 and 96 hours after removal.
Skin reactions are scored throughout the test by the same experienced assessor who made the baseline assessment and
under the same lighting source, following a pre-defined irritation and sensitization scoring scales.
Challenge controls:
A "negative" control is a patch without any product, applied in the same conditions as the product to be tested:
 if the product is tested pure: empty patch.
 if the product is tested diluted: patch with 0.02ml of the solvent used (demineralised water or mineral oil).

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
0.5
Group:
test group
Dose level:
0,02
No. with + reactions:
0
Total no. in group:
50
Clinical observations:
On 0 volunteers (0%) noticed slight erythema & dryness. In this clinical study there was no evidence of oedema.
Key result
Reading:
2nd reading
Hours after challenge:
24
Group:
test group
Dose level:
0,02
No. with + reactions:
0
Total no. in group:
50
Clinical observations:
On 0 volunteers (0%) noticed slight erythema & dryness. In this clinical study there was no evidence of oedema.
Key result
Reading:
other: 3rd reading
Hours after challenge:
48
Group:
test group
Dose level:
0,02
No. with + reactions:
0
Total no. in group:
50
Clinical observations:
On 0 volunteers (0%) noticed slight erythema & dryness. In this clinical study there was no evidence of oedema.
Key result
Reading:
other: 4th reading
Hours after challenge:
72
Group:
test group
Dose level:
0,02
No. with + reactions:
0
Total no. in group:
50
Clinical observations:
On 0 volunteers (0%) noticed slight erythema & dryness. In this clinical study there was no evidence of oedema.
Key result
Reading:
other: 5th reading
Hours after challenge:
96
Group:
test group
Dose level:
0,02
No. with + reactions:
0
Total no. in group:
50
Clinical observations:
On 0 volunteers (0%) noticed slight erythema & dryness. In this clinical study there was no evidence of oedema.
Key result
Reading:
1st reading
Hours after challenge:
0.5
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
50
Clinical observations:
On 0 volunteers (0%) noticed slight erythema & dryness. In this clinical study there was no evidence of oedema.
Key result
Reading:
2nd reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
50
Clinical observations:
On 0 volunteers (0%) noticed slight erythema & dryness. In this clinical study there was no evidence of oedema.
Key result
Reading:
other: 3rd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
50
Clinical observations:
On 0 volunteers (0%) noticed slight erythema & dryness. In this clinical study there was no evidence of oedema.
Key result
Reading:
other: 4th reading
Hours after challenge:
72
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
50
Clinical observations:
On 0 volunteers (0%) noticed slight erythema & dryness. In this clinical study there was no evidence of oedema.
Key result
Reading:
other: 5th reading
Hours after challenge:
96
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
50
Clinical observations:
On 0 volunteers (0%) noticed slight erythema & dryness. In this clinical study there was no evidence of oedema.

Any other information on results incl. tables

Skin reactions are scored throughout the test by the same experienced assessor who made the baseline assessment and under the same lighting source, following a pre-defined irritation and sensitization scoring scales.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Throughout the study, the product induced no reaction or irritation. The number of volunteers that presented an allergic reaction was 0 percent (0%).According to the experimental conditions of the study, the test product, can be considered as “Non Sensitizing”.