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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:
26. October 1998 - 14. January 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test was conducted before Testguideline for LLNA (OECD Guideline 429, 2002) was adopted

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction product of resin acid and rosin acid, 12-Hydroxyoctadecanoic and stearic acid with dipentaerythritol
EC Number:
685-540-0
Cas Number:
208126-52-7
Molecular formula:
from C112-130 H190-232 O13-19
IUPAC Name:
Reaction product of resin acid and rosin acid, 12-Hydroxyoctadecanoic and stearic acid with dipentaerythritol
Test material form:
solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 8-8-A
- Expiration date of the lot/batch: 4. March 1999
- Purity test date: not stated

RADIOLABELLING INFORMATION (if applicable)
not applicable

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: not stated
- Solubility and stability of the test substance in the solvent/vehicle: not stated
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
none

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Ibm: GOHI
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, Wölferstrasse 4, CH-4414 Füllinsdorf, Switzerland
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: SPF
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 408-426 g
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: one week
- Indication of any skin lesions: health examination performed before test,

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23 °C
- Humidity (%): 30-70
- Air changes (per hr): 10 -15 /h
- Photoperiod (hrs dark / hrs light): 12 / 12
- IN-LIFE DATES: 26. October - 3. December 1999

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
5% test article in corn oil, 0.1 mL intradermal,
0.3 g test article, 75 % in corn oil, dermal application
Day(s)/duration:
Day 1 (intradermal application), Day 8 (Epidermal application, 48 h) Day 22 (Challenge application, 24 h)
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
Challenge
No.:
#1
Route:
epicutaneous, semiocclusive
Vehicle:
corn oil
Concentration / amount:
75 %
Day(s)/duration:
1
Adequacy of challenge:
not specified
No. of animals per dose:
10
Details on study design:
RANGE FINDING TESTS:
Intradermal Injection: According to Magnusson - Kligman and to the findings observed, the concentration selected for the main study was 5 %.
Epidermal application: According to Magnusson -Kligman and to the findings observed, the test article at 75 % was considered to be the maximally tolerated concentration to stimulate a state of immune hypersensitivity and the highest non-irritating concentration to be used for the challenge.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal, epidermal)
- Exposure period: 24 h for epidermal application
- Test groups: all
- Control group: all
- Site: dorsal skin from the scapular region (approx. 6 x 8 cm),
- Frequency of applications: intradermal 1, epidermal 1
- Duration: 24 h for epidermal application
- Concentrations: intradermal: 5 % in corn oil, epidermal: 75% in corn oil

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 h
- Test groups: all
- Control group: all
- Site: left or right flank, 5 x 5 cm
- Concentrations: 75 % in corn oil
- Evaluation (hr after challenge): 24 and 48 hours after removal of dressing
Challenge controls:
none stated
Positive control substance(s):
yes

Results and discussion

Positive control results:
Twenty percent of the test animals were observed with a very slight erythematous reaction at
the 24-hour reading after treatment with ALPHA-HEXYLCINNAMALDEHYDE at 1 % in
PEG 400. The same reactions still persisted at the 48-hour reading in two animals and were
also observed in a third animal. No reaction was observed in the control group I.
During the second challenge 90 % (at the 24-hour reading) and 80 % (at the 48-hour reading)
of the test animals were observed with very slight to well-defined (in one animal only)
erythema when treated with the test article at 5 % in PEG 400. The control group I, previously
exposed to the test article during the first challenge, also reacted up to 60 %. Although
erythematous reactions were observed in two animals used as pretest after epidermal
application of the test article at 5 %, no skin reaction was observed in the 5 animals of the
control group II (with FCNphysiological saline pretreatment), prepared in the same
conditions as the animals of the epidermal pretest and also treated as the control group I and
test group in the second challenge.
After treatment with the test article at 3 % in PEG 400, 40 % (at the 24-hour reading) and
30 % (at the 48~hour reading) of the test animals were observed with very slight erythematous
reactions while no skin reaction was observed in the control group I and II.
Therefore, the test article ALPHA-HEXYLCINNAMALDEHYDE applied at a concentration
of 1 %, 3 % and 5 % in PEG 400 is considered to be a sensitizer when used under the described test conditions.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
75 % in corn oil
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
75 % corn oil
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
5% Alpha-Hexylcinnamaldehyde
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
none
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
5 % Alpha-Hexylcinnamaldehyde
No. with + reactions:
8
Total no. in group:
10
Clinical observations:
none

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In this study none of the animals of the test group were observed with erythematous reactions
after treatment with a non-irritant test article concentration of 75 % in corn oil. No skin
reactions were observed in the control group.
Therefore, the test article COSMOL 168AR applied at a concentration of 75 % in corn oil is
considered not to be a sensitizer when used under the described test conditions.
Executive summary:

In order to assess the cutaneous allergenic potential of COSMOL 168AR, the MaximizationTest

was performed in 15 (10 test and 5 control) female albino guinea pigs, in accordance

with OECD Guideline No. 406 and the Directive 96/54/EEC, B.6.

The intradermal induction of sensitization was performed with a 5 % dilution of the test

article in corn oil and in an emulsion of Freund's Complete Adjuvant (FCA) I physiological

saline. The epidermal induction of sensitization was conducted under occlusion with the test

article at 75 % in corn oil. Two weeks after the epidermal induction application the challenge

was completed by epidermal application of the test article at 75 % in corn oil under occlusive

dressing. The animals of the control group were induced with corn oil and FCA/physiological

saline and challenged similarly to those of the test group. Cutaneous reactions, i.e. erythema

and eschar, as well as oedema formation were evaluated at 24 and 48 hours after removal of

the dressing.

       Erythematous Resations after the challenge procedure
  after 24 hours  after 48 hours 
   positive / total / % positive of total positive / total / % positive of total 
 Control group    
 Cosmol 168 AR (left flank) 0 / 5 / 0    0 / 5 / 0 
 Corn oil only (right flank)   0 / 5 / 0    0 / 5 / 0 
 Test Group    
 Cosmol 168 AR (left flank)   0 / 5 / 0    0 / 5 / 0 
 Corn oil only (right flank)   0 / 5 / 0    0 / 5 / 0 

No toxic symptoms were evident in the guinea pigs of the control or test group.

No deaths occured.