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Description of key information

According to clinical study (human repeat patch test) OF14 ATS was considered as non-irritating and non-sensitising.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation, other
Remarks:
Human Repeat Insult Patch Test
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2 November 2015 - 9 January 2016
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Human Repeat Insult Patch Test using generally-accepted methods.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Repeated Insult Patch Test was performed to confirm that repeated applications of the product under maximized conditions, in healthy subjetcs, does not induce delayed contact allergy reactions. A secondary objective is to determine the irritating potential of the product first after a single application and second after repeated applications.
GLP compliance:
no
Remarks:
study has been conducted in the spirit of the good Clinical Practice
Type of study:
patch test
Justification for non-LLNA method:
HRIPT study in human volunteers already available
Details on the study design:
Not applicable
Details on the study design:
Not applicable
Species:
other: Human
Details on test animals and environmental conditions:
- Number of subjects empanelled: 110
- Number of subjects completed the study: 106 (4 drop out)
- Age: 18-68 years
- The subjects choosen cooperative subjects, aware of tge necessity and duration of the controls so that perfect adhesion to the procol established by Dermscan could be expected.
Inclusion citeria were: subjects having given their informed, written consent and subjects without scars, tatoos, any pigmentary marks, ecessive pilosity and uneven skkin tone or active dermal lesions, on the concerned areas of the back.
Details on study design:
Monocentric and simple blind study.

TYPE OF TEST(S) USED: patch test

ADMINISTRATION
- Type of application: occlusive
- Application area: The back: homolateral (Induction site) and contralateral (challenge site)
- Description of patch: Finn's chamber occlusive (8 mm) (50 mm²)
- Volume applied: 25 µL
The studied product was applied to a cleansed (with physiological saline or water) and dry skin.
- Application frequency:
Induction phase: 3 times a week during 48 hours (72 h for the week-end)
Challenge phase: once durig 48 hours
- Study schedule: cf Any other information on materials and methods Table 2

EXAMINATIONS
After each application, the patch is removed and the clinical examination is performed by the investigator 30 minutes later in order to eliminate the pressure and the occlusive effects. The resulf ot the examination id negative if the skin looks normal. The clinical examination is made on the back using the following criteria and scale:

Clinical criteria regarding the irritating potential (induction phase)
- Grading/Scoring system:
0 = No erythema, no edema
0.5 = very slight = erythema: bareky perceptible: pinkish coloration of one part of the tested area and palpable and barely visible edema
1 =Slight = eruthema: pinkish coloration of the complete tested area or rather visible on one part of the tested area, and palpable and visible edema
2 =Net = obvious erythema covering the whole tested arean and obvious edema (thickness <1mm) with or without blister or vesible
3 = important = severe erythema covering all the tested area or obvious erythema diffusion outside the tested area, and severe edema (thickness > 1mm of diffusiong outside the tested area) with our without vesicle or blister.

Clinical criteria regarding the sensitizing potential ( challenge phase) : cf. Any other information on materials and methods Table 1
Key result
Reading:
1st reading
Group:
test chemical
Dose level:
25 µL of OF14 ATS
No. with + reactions:
0
Total no. in group:
106
Clinical observations:
During the induction or challenge phase, no skin reactions were observed. “OF14 ATS” showed a score of 0.01. No reaction ++  nor +++  was observed, so the product “OF14 ATS” can be considered as non-sensitizing

RESULTS INTERPRETATION:

At the end of the 9 readings of the induction phase, the average score of each subject (Cumulative irritation index CII) is calculated by adding the scores obtained for each readings and by dividing this sum by the actual number of readings.

The irritating potential of the product is estimated by calculating the mean of the reactions observed during the induction phase in order to obain the Mean cumulative Irritation Inde (MCII). the obtained index allows to arbitrarily classify the studied product according to the following scale:

M.C.I.I.

 Classe

 M.C.I.I. < 0.25

 Non irritating (NI)

 0.25 ≤M.C.I.I. < 0.50

 Very slightly irritating (VSI)

 0.5≤ M.C.I.I. < 1

 Slightly irritating (SI)

 1 ≤M.C.I.I. < 2

 Moderately irritating (MI)

 M.C.I.I. ≥2

 Irritating (I)

Challenge phase:

A possible reaction during the induction or challenge phase is assessed from 0 to 3 according to ICDRG (International Contact Dermatitis Research Group) (see table 1) . During the Challenge phase, the reading is done 30 minutes after patch-tests removal and 48 hours later. The sensitizing potential of the product is assessed by the readings on D37 and D39 according to the following criteria reaction++ or +++ in the absence of added irritation phenomenon. The presence of only one case of active sensitization or controlateral side leads to the conclusion "Potentially sensitizing product".

Interpretation of results:
GHS criteria not met
Conclusions:
Under these study conditions, the product “OF14 ATS” can be considered non-irritating and non-sensitizing
Executive summary:

A panel of 110 male and female human volunteers participated in a repeat insult patch test in which a test product OF14 ATS applied to the back of the subjects under occlusive patches. 106 subjects completed the study.

During the induction or challenge phase, no skin reactions were observed.“OF14 ATS” showed a score of 0.01. It can thus be considered as non-irritating.

No reaction ++  nor +++  was observed, so the product “OF14 ATS” can be considered as non-sensitizing

Under these study conditions, the product “OF14 ATS” can be considered non-irritating and non-sensitizing

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A panel of 110 male and female human volunteers participated in a repeat insult patch test in which a test product OF14 ATS applied to the back of the subjects under occlusive patches. 106 subjects completed the study.

During the induction or challenge phase, no skin reactions were observed.“OF14 ATS” showed a score of 0.01. It can thus be considered as non-irritating.

No reaction ++  nor +++  was observed, so the product “OF14 ATS” can be considered as non-sensitizing

Under these study conditions, the product “OF14 ATS” can be considered non-irritating and non-sensitizing

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In a human repeat insult patch test, the test item was concluded to be non-irritating and non-sensitising. Based on this result and due to the nature of the main constituents of the registered substance (oligo/polysaccharides), the registered substance does not need to be classified as skin sensitiser.

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