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Diss Factsheets

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:
14 December 2015 to 20 January 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test
Justification for non-LLNA method:
The LLNA is the study of choice for skin sensitisation. As detailed in the OECD 429 guideline, despite the advantages of the LLNA, it should be recognised that there are certain limitations that may necessitate the use of TG 406. Chemical groups such as metal salts, organometal, unsaturated compounds and surfactants have been known to be linked to false positive. The Substance is considered to be amphiphilic in nature and therefore would likely have surfactant characteristics, which are known to be falsely positive in the LLNA. Therefore a Guinea Pig Study, OECD 406, was selected to decrease the uncertainty of possible falsely positive effects.

Test material

1
Reference substance name:
Fatty acids, tallow, compds. with triethanolamine
EC Number:
263-158-1
EC Name:
Fatty acids, tallow, compds. with triethanolamine
Cas Number:
61790-67-8
IUPAC Name:
Fatty acids, tallow, esters of triethanolamine
Test material form:
liquid
Details on test material:
Appearance: Brown liquid
Storage: At ambient temperature, protected from light
Specific details on test material used for the study:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
For the purpose of the study, the test item was prepared immediately prior to dosing in liquid paraffin for the topical applications (pre-test). This vehicle was chosen as it produced the most suitable formulation at the required concentration. Indeed, the preparation of the test item at 50 % in liquid paraffin (w/w) was a yellow solution.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 2 or 3 weeks old.
- Weight at study initiation: Between 242 g and 268 g.
- Housing: The animals were housed individually or in groups of two in polycarbonate cages. The flooring of the cages was covered with dust-free wood shavings and the top fitted a stainless steel lid containing a feeding device and drinking device of 500 mL.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: Minimum acclimatization period of 5 days under housing and diet conditions identical to those of the test.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C ± 3 °C
- Humidity (%): from 30 % to 70 %
- Air changes (per hr): At least 10 cycles per hour
- Photoperiod (hrs dark / hrs light): Circadian cycle (12 hrs day/ 12 hrs darkness)

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
100 % in liquid paraffin
Day(s)/duration:
6 hours
Adequacy of induction:
highest technically applicable concentration used
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100% test item
Day(s)/duration:
6 hours
Adequacy of induction:
highest technically applicable concentration used
Challengeopen allclose all
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
100 % in liquid paraffin
Day(s)/duration:
6 hours
Adequacy of challenge:
highest non-irritant concentration
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100% test item
Day(s)/duration:
6 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Control group: 10 animals
Test material group: 20 animals
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 local applications
- Exposure period: 6 hours under an occlusive dressing (25mm x 50mm non-woven swab of 4-layer patch from MEDISTOCK held in contact with the skin by means of 50 mm wide hypoallergenic micropore™ adhesive tape from 3M and Blenderm™ from 3M).
- Site: The animals were carefully shorn before each test item application on the inter-scapular zone.
- Frequency of applications: Applications were performed on Day 0, Day 7 and Day 14. Animals were then left untreated for 13 days.
- Concentrations: 100 % diluted at 75 %, 50 %, and 25 % (0.5 mL).
- Removal: Washing of the skin after removal of the dressing was done with liquid paraffin.

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 6 hours
- Test groups: On the previously shorn dorso-lumbar zone, an application on either side of the spine, under occlusive dressing (25mm x 50mm non-woven swab of 4-layer patch from MEDISTOCK held in contact with the skin by means of 50 mm wide hypoallergenic micropore™ adhesive tape from 3M and Blenderm™ from 3M).
- Control group: On the previously shorn dorso-lumbar zone, an application on either side of the spine, under occlusive dressing (25mm x 50mm non-woven swab of 4-layer patch from MEDISTOCK held in contact with the skin by means of 50 mm wide hypoallergenic micropore™ adhesive tape from 3M and Blenderm™ from 3M).
- Site: On the previously shorn dorso-lumbar zone on either side of the spine.
- Concentrations: 0.5 mL of the undiluted test material on the left flank and 0.5 mL of liquid paraffin in the right flank.
Removal: Washing of the skin after removal of the dressing was done with liquid paraffin.
- Evaluation (hr after challenge): A macroscopic evaluation of the cutaneous reactions (erythema and oedema) was conducted and all the local or systemic reactions were recorded for animals of the control and treated groups. Approximately 24 hours after removal of the occlusive dressing, the cutaneous reactions were observed and graded according to the scales given below.
- Approximately 24 hours later (i.e. 48 hours after removal of the occlusive dressing), a second observation was made.

Grading scale:
0 No visible change
1 Discrete or patchy erythema
2 Moderate and confluent erythema
3 Intense erythema and swelling

OTHER:
The animals were weighed at the beginning of the study, before the second induction and at the end of the study.
Challenge controls:
The animals of the control groups were subject to the same experimental procedure as the treatment groups.
Positive control substance(s):
no

Results and discussion

Positive control results:
alpha-Hexylcinnamaldehyde (CAS: 101-86-0) showed sensitisation at 24 and 48 hours.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100% liquid paraffin
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none observed
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100 % test item
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none observed
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100 % test item
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none observed
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100% liquid paraffin
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none observed
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
50%
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
sensitisation
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
50%
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
sensitisation
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
25%
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
sensitisation
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
25%
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
sensitisation
Remarks on result:
positive indication of skin sensitisation

Any other information on results incl. tables

Preliminary study

24 and 48 hours after removal of the patches, no cutaneous reaction was noted at all tested concentrations. In view of these results, the concentration selected was 100 % for the 3 inductions of the main study and the concentration selected was 100 % (MNIC) for the challenge phase.

Main study:

- Induction phase: After the first induction, no cutaneous reaction was noted in the treated group. After the second induction, discrete erythema was noted in seven animals (7 /20) and no cutaneous reaction was noted in the other animals (13/20) of the treated group.

After the third induction, moderate erythema was noted in one animal (1/20), discrete erythema was noted in one animal (1/20), and no cutaneous reaction was noted in the other animals (18/20) of the treated group.

No cutaneous reaction was recorded during the induction phase in the control group.

- Challenge phase: The concentration selected for the induction phase and the challenge was based on the result of the pre-test. Readings were performed 24 and 48 hours after removal of the patches.

In the treated group (treatment concentration of 100 %), no macroscopic cutaneous reactions attributable to allergy were recorded during the examination following the removal of the occlusive dressing (challenge phase).

In the control group (associated with the treatment concentration of 100 %), no cutaneous reaction was observed during the examination following the removal of the occlusive dressing.

In the treated group on the treated area with liquid paraffin, no macroscopic cutaneous reactions attributable to allergy were recorded during the examination following the removal of the occlusive dressing (challenge phase).

No cutaneous reaction was recorded in animals from the control groups after the challenge phase, on the treated area with liquid paraffin (control item).

Weight evolution

No abnormalities and no differences in the body weight between the control and the treated group were observed.

Mortality

No mortality occurred during the main test.

Clinical signs

No abnormal clinical signs related to the administration of the test item were observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material was considered to be a non-sensitiser under the conditions of this study in accordance with EU criteria.
Executive summary:

The potential of the test material to act as a sensitiser was investigated in a GLP study in accordance with the standardised guidelines OECD 406, EU Method B.6 and US EPA OPPTS 870.2600.

After induction of 20 guinea-pigs by 3 topical applications with the test item applied as supplied (100 %) under occlusive dressing and a 13-day rest phase, the challenge phase, under occlusive dressing for 6 hours, consisted to a single topical application of the test item at 100 % and of a negative control (liquid paraffin). The concentration selected for the induction phase and the challenge based on the result of a pre-test. Readings were performed 24 and 48 hours after removal of the patches.

In the treated group (treatment concentration of 100 %), no macroscopic cutaneous reactions attributable to allergy was recorded during the examination following the removal of the occlusive dressing (challenge phase). In the control group (associated with the treatment concentration of 100 %), no cutaneous intolerance reaction was observed during the examination following the removal of the occlusive dressing. In the treated group on the treated area with liquid paraffin, no macroscopic cutaneous reactions attributable to allergy was recorded during the examination following the removal of the occlusive dressing (challenge phase). No cutaneous reaction was recorded in animals from the control groups after the challenge phase, on the treated area with liquid paraffin (control item).

In conclusion, the test material was considered to be a non-sensitiser under the conditions of this study in accordance with EU criteria.