Registration Dossier
Registration Dossier
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EC number: 943-098-9 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 August 2016 - 21 September 2016
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- O.E.C.D. Test Guideline No. 406 dated July 17th, 1992, and
method B.6 of the Council Regulation No. 440/2008. - GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Initially OECD 429 Local Lymph Node Assay was selected to test the property, but following extended solubility testing the study was cancelled as considered inappropriate. In fact the applicable suspension could not be achieved since even upon constant stirring, the nanotubes clotted the tip of the pipette and the test item could not be used.
As a second attempt, the OECD 406 Skin Sensitisation (Magnusson & Kligman Maximisation) was tried. Also in this case solubility made it unsuitable as the particles block the needles used to inject intradermally, and the study was cancelled. As a consequence, Buehler test was performed since the test items could be applied according to its conditions. - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- The animals were housed in groups of 2 or 3 in polycarbonate containers. The flooring of the cages was covered with dust-free wood shavings and the top fitted a stainless steel lid containing with a feeding device and drinking device of 500 mL.
The containers are placed in an air-conditioned animal holding facility:
- Air recycling: at least 10 cycles per hour,
- Temperature: 22° C ± 3° C,
- Relative humidity: from 30 % to 70 %,
- Lighting: circadian cycle (12 hrs day / 12 hrs darkness). - Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 20%
- Day(s)/duration:
- 3 topical applications under occlusive dressing for 6 hours and 13-day rest phase
- Adequacy of induction:
- other: Maximal Non Irritant Concentration based on results of pre-tests in 3 animals.
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 20%
- Day(s)/duration:
- Conducted under occlusive dressing for 6 hours. Readings were performed 24 and 48 hours after removal of the patches.
- Adequacy of challenge:
- other: Maximal Non Irritant Concentration based on results of pre-tests in 3 animals.
- No. of animals per dose:
- GROUP 1 (control): 10 female guinea pigs
GROUP 2 (treated): 20 female guinea pigs - Challenge controls:
- Solvent alone : vaseline
- Positive control substance(s):
- yes
- Remarks:
- α-Hexylcinnamaldehyde
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no macroscopic cutaneous reactions attributable to allergy were observed
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no macroscopic cutaneous reactions attributed to allergy were observed
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- pure solvent
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no cutaneous intolerances reactions were observed during the examination
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- pure solvent
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no cutaneous intolerances reactions were observed during the examination
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- α-Hexylcinnamaldehyde as positive control
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- α-Hexylcinnamaldehyde as positive control
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item does not need to be classified as sensitizer.
- Executive summary:
The aim of the study was to evaluate the possible allergenic activity of the test item Tuball after topical administration in guinea pigs.
The concentrations selected for the induction phase and the challenge based on the result of one pretest in 3 animals.
Readings were performed 24 and 48 hours after removal of the patches.
In the treated group (treatment dose of 20%), no macroscopic cutaneous reactions attributable to allergy were observed 24 and 48 hours following the removal of the occlusive dressing.
In the control group (associated with the treatment dose of 20%), no cutaneous intolerance reactions were observed during the examination following the removal of the occlusive dressing.
No cutaneous reaction was recorded in animals from the treated and control groups after the challenge phase, on the treated area with vaseline.
Reference
No abnormalities and no differences in the body weight between the control and the treated group were observed.
No mortality was registered during the main test.
No abnormal clinical signs related to the administration of the test item were observed.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
In the treatment group no macroscopic cutaneous reactions attributed to allergy were observed 24 and 48 hours following removal of the occlusive dressing.
In the control group no cutaneous intolerances reactions were observed during the examination following the removal of the occlusive dressing.
No cutaneous reaction was recorded in animals from the treated and controls groups after the challenge phase on the treated area with Vaseline.
The test item does not need to be classified as sensitizer.
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