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Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD and GLP-compliant study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (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:
guinea pig maximisation test
Justification for non-LLNA method:
Data generated before 10 May 2017.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:Charles River Laboratories, Research Models and Services, Germany GmbH, Stolzenseeweg 32 – 36, 88353 Kisslegg
- Age at study initiation:5 – 8 weeks
- Weight at study initiation:261 g - 289 g
- Housing:The animals were housed in fully air-conditioned rooms.
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:at least 5 days before the first test-item application

ENVIRONMENTAL CONDITIONS
- Temperature (°C):20 – 24°C
- Humidity (%):30 – 70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)
Route:
intradermal and epicutaneous
Vehicle:
other: Corn oil (induction), acetone (challenge)
Concentration / amount:
Intradermal Induction:
Test item 5 % in corn oil (w/w)
Test item 5 % in Freund’s complete adjuvant / 0.9% aqueous NaCl-solution (1 : 1)

Epicutaneus Induction:
Test item 25 % in corn oil (w/w)

1ST CHALLENGE
Test item 5 % in acetone (w/w)
Route:
epicutaneous, occlusive
Vehicle:
other: Corn oil (induction), acetone (challenge)
Concentration / amount:
Intradermal Induction:
Test item 5 % in corn oil (w/w)
Test item 5 % in Freund’s complete adjuvant / 0.9% aqueous NaCl-solution (1 : 1)

Epicutaneus Induction:
Test item 25 % in corn oil (w/w)

1ST CHALLENGE
Test item 5 % in acetone (w/w)
No. of animals per dose:
Number of animals per control group: 5 + 1 (spare animal)
Number of animals of the test group: 10 + 1 (spare animal)
Details on study design:
RANGE FINDING TESTS:
1st pretest:
Amount applied: 6 intradermal injections in groups of two per animal were applied to each animal.
A) front row: 2 injections each of 0.1 ml Freund´s complete adjuvant without test item emulsified with 0.9 % aqueous NaCl-solution in a ratio of 1:1
B)middle row: 1 injection of 0.1 ml test item concentration of 50 % and 1 injection of 0.1 ml test item concentration 25 % in corn oil (w/w)
C) 1 injection of 0.1 ml test item concentration of 10 % and 1 injection of 0.1 ml test item concentration 5 % in corn oil (w/w)
Application site: Neck region
Number of test animals: 3 (4 test item concentrations)
Readings: 24 h and 48 h after the beginning of application
4 test item concentrations: 100 % , 75 %, 50 % and 25 % diluted with acetone (w/w) were applied to the left and right flanks of the same animals 7 days later.
Duration of exposure: 24 hours
Readings: 24 h and 48 h after the end of the exposure

2nd pretest:
Amount applied: 6 intradermal injections in groups of two per animal were applied to each animal.
A) front row: 2 injections each of 0.1 ml Freund´s complete adjuvant without test item emusified with 0.9 % aqueous NaCl-solution in a ratio of 1:1
B) middle row: 2 injections each of 0.1 ml test item concentration of 2.5 % in corn oil (w/w)
C) back row: 2 injections each of 0.1 ml test item concentrations of 1 % in corn oil (w/w)
Application site: Neck region
Number of test animals: 3 (2 test item concentrations)
Readings: 24 h and 48 h after the beginning of application

3rd pretest
Amount applied: 0.5 mL of the test-item preparation was applied to each animal
Occlusive dressing: The test patches were fully loaded with the test item, applied to the skin and fixed with a strip of Fixomull stretch.
Occlusion was obtained by covering with teflon foil which was fixed with Guinea Pig Jacket
Duration of exposure: 24 hours
Application site: Flank
Number of test animals: 6 (5 test item concentrations)
Readings: 24 h and 48 h after removal of the patch

MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal induction: 6 intradermal injections in groups of two per animal were given.
Injections for the control group:
A) front row: 2 injections each of 0.1 mL Freund’s complete adjuvant without test item emulsified with 0.9% aqueous NaCl-solution in a ratio of 1 : 1
B) middle row: 2 injections each of 0.1 mL of the undiluted vehicle
C) back row: 2 injections each of 0.1 mL of a 50% formulation of the vehicle without test item emulsified with Freund’s complete adjuvant/ 0.9% aqueous NaCl-solution (1 : 1)
Injections for the test group:
A) front row: 2 injections each of 0.1 mL Freund’s complete adjuvant without test item emulsified with 0.9% aqueous NaCl solution in a ratio of 1 : 1
B) middle row: 2 injections each of 0.1 mL of a test-item preparation in an appropriate vehicle at the selected concentration
C) back row: 2 injections each of 0.1 mL Freund’s complete adjuvant/ 0.9% aqueous NaCl solution (1 : 1) with test item at the selected concentration.
Application site: Neck region
Readings: 24 h after the beginning of application

Epicutaneous induction: Epicutaneous induction was carried out one week after intradermal induction.
Amount applied: 1 mL of the test-item preparation was applied to each animal.
Occlusive dressing: The test patches were fully loaded with the test item, applied to the skin and fixed with a strip of Fixomull stretch
Occlusion was obtained by covering with teflon foil which was fixed with Guinea Pig Jacket
Duration of exposure: 48 hours
Application site: Neck region, same area as in the case of the previous intradermal application
Readings: Directly after removal of the patch
The control group was treated analogously to the test group but only with the vehicle without the test item.


B. CHALLENGE EXPOSURE
The 1st challenge was carried out 14 days after the epicutaneous induction.
Amount applied: 0.5 mL of the test-item preparation was applied to each animal.
The test group and control group were treated with the test-item preparation. Additionally, acetone was applied as a vehicle control.
Occlusive dressing: The test patches were fully loaded with the test item, applied to the skin and fixed with a strip of Fixomull stretch
Occlusion was obtained by covering with teflon foil which was fixed with Guinea Pig Jacket
Duration of exposure: 24 hours
Application site: Flank
test item: right flank posterior
vehicle: left flank posterior
Readings: 24 and 48 h after the removal of the patch


Challenge controls:
A positive control (reliability check) with a known sensitizer is not included in this study. However, a separate study is performed twice a year in the laboratory.
The positive controls with Alpha-Hexylcinnamaldehyde, techn. 85% showed that the test system was able to detect sensitizing compounds under the laboratory conditions chosen.
Positive control substance(s):
yes
Remarks:
Alpha-Hexylcinnamaldehyde
Positive control results:
The sensitivity of Charles River Guinea pigs (Dunkin Hartley, Crl:HA, Charles River Laboratories, Research Models and Services, Germany GmbH, 88353 Kisslegg) and the reliability of experimental techniques was assessed regularly using a known sensitizer as recommended by the test guidelines.
The study procedures were based on the methods of Magnusson and Kligmann (1969) (Maximization Test).

The last check was performed with "HEXYL CINNAMIC ALDEHYDE" (HCA):

Name of Test item: Alpha-Hexylcinnamaldehyde, techn. 85%
CAS number: 101-86-0
Concentrations:
Project No.: TOX139
Intradermal Induction:Test item 2.5% in corn oil, Test item 2.5% in Freund’s complete adjuvant / 0.9%, aqueous NaCl solution (1:1)
Epicutaneous Induction: Test item 100 % (as is)
Challenge: Test item 75 % in acetone
Project No.: TOX144
Intradermal Induction: Test item 2.5% in corn oil, Test item 2.5% in Freund’s complete adjuvant / 0.9% , aqueous NaCl solution (1:1)
Epicutaneous Induction: Test item 100 %
Challenge: Test item 75 % in acetone

Project No.: 151
Intradermal Induction: Test item 2.5% in corn oil, Test item 2.5% in Freund’s complete adjuvant / 0.9%, aqueous NaCl solution (1:1)
Epicutaneous Induction: Test item 100 %
Challenge: Test item 75 % in acetone

All tests indicated a clear skin sensitizing potential of HEXYL CINNAMIC ALDEHYDE (HCA)
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
Test item 5 % in acetone
No. with + reactions:
5
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Test item 5 % in acetone . No with. + reactions: 5.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Test item 5 % in acetone
No. with + reactions:
4
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: Test item 5 % in acetone . No with. + reactions: 4.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
acetone
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: acetone. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
acetone
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: acetone. No with. + reactions: 0.0. Total no. in groups: 5.0.
Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
The substance was found to be sensitizing to skin.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

The substance was tested for sensitizing potential in a in a Guinea pig maximisation test in accordance with OECD 406 and GLP where 11 Dunkin-Hartley guinea pigs were treated with 5% of the substance in acetone. As a result, 5 of 10 animals showed sensitizing skin effects at the 24 reading, while 4 of 10 animals showed such effects after 48 h. Based on these results, the substance was regarded as sensitizing to skin.



Short description of key information:
The test substance is sensitising in guinea pigs (OECD 406)

Justification for selection of skin sensitisation endpoint:
OECD guideline study according to GLP

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

There are conclusive data for classification of the test substance with regard to skin sensitisation.

The test substance is classified for this endpoint in accordance to Directive 67/548/EEC or the CLP Regulation (EC) No 1272/2008.