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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:
From 11 august 2004 to 1 october 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Compliant to GLP and testing guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

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
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was performed before the implementation of the REACH regulation

Test material

Constituent 1
Chemical structure
Reference substance name:
Bisdecanoyl peroxide
EC Number:
212-092-1
EC Name:
Bisdecanoyl peroxide
Cas Number:
762-12-9
Molecular formula:
C20H38O4
IUPAC Name:
decanoyl decaneperoxoate
Test material form:
solid: compact

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories France, l'Arbresle, France
- Age at study initiation: 1-2 months
- Weight at study initiation: males: 348+/-17 g ; females 353 +/-18 g
- Housing: housed individually in polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm) equipped with a propylene bottle
- Diet (e.g. ad libitum): free access to 106 pelleted diet
- Water (e.g. ad libitum): filtered by a FG Millipore membrane (0,22 micron), provided ad libitum
- Acclimation period: 5 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 2
- Humidity (%): 30 to 70 %
- Air changes (per hr): 12 cycles/hour
- Photoperiod (hrs dark / hrs light): 12h/12

IN-LIFE DATES: From: 11 august 2004 To: 1 october 2004

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
corn oil
Concentration / amount:
0.5%
Day(s)/duration:
Day 1
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
other: acetone
Concentration / amount:
5%
Day(s)/duration:
Day 8
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: acetone
Concentration / amount:
0.5%
Day(s)/duration:
Day 22
Adequacy of challenge:
highest non-irritant concentration
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
other: acetone
Concentration / amount:
0.1% (left flanck)
Day(s)/duration:
Day 36
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
other: acetone
Concentration / amount:
0.05% (right flanck)
Day(s)/duration:
Day 36
No. of animals per dose:
20 animals per dose
10 animals for controls
Details on study design:
RANGE FINDING TESTS:
-Compounds solubility: test item was not soluble in 0.9% NaCl and in ethanol/water (80/20, w/w).
For intradermal induction: corn oil was choosen
An homogeneous suspension was observed at the maximum concentration of 5%
For topical application: acetone was choosen
A solution was obtained at the maximum concentration of 25% (w/w)
irritation: For intradermal route, irritation was observed in all tested concentrations (5%, 2.5%, 1%). The concentration chosen for the main study was 0.5% (w/w)
For cutaneous route, irritation score was 2 for 10% and 1 for 5%. The concentration chosen for the main study was 5% (w/w) for the induction phase and 0.5% (w/w) for the challenge application

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: intradermal induction the 1st day, and epicutaneous occlusive patch during 48 hours the 8th day
- Frequency of applications: 3 intradermal injections, 1 topical application
- Duration: the topical application was occlusive during 48 hours
- Site: intradermal induction were performed in the interscapular region of all animals
topical application were performed in the same site
- Concentrations: intradermal induction was 0.5% (w/w); the topical induction was 5%
- Test groups: intradermal induction: 3 injections - FCA with 0.9% NaCl - test item in corn oil -test item in a mixture FCA/0.9% NaCl
Topical application: test item in acetone
- Control group: intradermal induction 3 injections - FCA with 0.9% NaCl - vehicule alone -vehicule in a mixture FCA/0.9% NaCl
Topical application: vehicule alone

B. CHALLENGE EXPOSURE
First challenge
- No. of exposures: 1
- Day of challenge: 22
- Exposure period: 24 hours
- Test groups: occlusive patch with 0.5% of test item
- Control group: occlusive patch with vehicule alone
- Site: the site was the same that induction
- Concentrations: 0.5% of test item
- Evaluation: skin reactions were evaluated approximately 24 and 48 hours after removal of the dressing

2nd challenge
- No. of exposures: 1
- Day of challenge: 36
- Exposure period: 24 hours
- Test groups: occlusive patch with 0.1% of test item in the left flanck, and 0.05% of test item in the right flanck
- Control group: occlusive patch with vehicule alone
- Site: the site was the same that induction
- Concentrations: 0.1% and 0.05% of test item
- Evaluation: skin reactions were evaluated approximately 24 and 48 hours after removal of the dressing
Challenge controls:
vehicules: for intradermal injections : corn oil, for topical applications: acetone.
Positive control substance(s):
yes
Remarks:
Mercaptobenzathiole

Results and discussion

Positive control results:
positive control was a periodic test and was performed in march 2004 (5 months before the test). Substance was Mercaptobenzothiazole (CAS n° 149-30-4). Under experimental conditions and according to the Magnusson and Kligman method, the test item Mercaptobenzothiazole induced positive skin sensitization reactions in 80% guinea pigs

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5%
No. with + reactions:
11
Total no. in group:
20
Clinical observations:
discrete and moderate erythema (grade 1 or 2)
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5%
No. with + reactions:
7
Total no. in group:
20
Clinical observations:
discrete and moderate erythema (grade 1 or 2)
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.5%
No. with + reactions:
3
Total no. in group:
10
Clinical observations:
discrete erythema (grade 1)
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.5%
No. with + reactions:
3
Total no. in group:
10
Clinical observations:
discrete erythema (grade 1)
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
discrete erythema (grade 1)
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
0.1%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
0.1%
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
discrete erythema (grade 1)
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
0.1%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
0.05%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
0.05%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
0.05%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
0.05%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
1%
No. with + reactions:
8
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
1%
No. with + reactions:
8
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under experimental conditions and according to the maximization method of magnusson and Kligman, the test item DIDECANOYL PEROXYDE, should not be considered as a skin sensitizer.
Executive summary:

The delayed contact hypersensivity of didecanoyl peroxide was evaluated in Guinea pigs according to OECD N°406 guideline (July 17th1992 - Magnusson and Kligman test).

The induction phase has been realized both by intradermal route on day 1 (didecanoyl peroxide 0.5 % in corn oil) and by cutaneous route on day 8 (concentration = 5%). 30 guinea pigs were allocated to 2 groups of guinea pigs: 5 males and 5 females for control group and 10 males and 10 females for treated group. The first challenge phase was realized on day 22 by cutaneous application of didecanoyl peroxide 0.5 %; the cutaneous reactions were scored 24 and 48 hours after the challenge phase. As equivocal cutaneous reactions were noted after the first challenge, a second challenge application was performed on day 36. The test item was applied at the concentration of 0.1% (w/w) in acetone to the left flanck and at the concentration of 0.05% (w/w) in acetone to the right flanck of animals of both groups, under the same experimental conditions as for the first challenge. 

 

No systemic clinical signs and no deaths were noted during the study.

After the first challenge application, a discrete erythema, together with dryness of the skin in one animal at the 48-hour reading, was observed in 3/10 animals of the controle group at the 24 and 48-hour reading.

In the treated group, a discrete or moderate erythema was noted in 11/20 animals at the 24-hour reading and persisted in seven of them at the 48-hour reading. Dryness of the skin was also recorded in 5/20 animals at the 48-hour reading.

 

After the second challenge application, no relevant cutaneous reactions were recorded.

 As the cutaneous reactions observed in the animals of the treated group were of similar incidence and severity when compared to those recorded in the animals of the control group, they were not attributed to delayed contact hypersensitivity.

   

In conclusion, under these experimental conditions, didecanoyl peroxide was considered as non-sensitizing in the Guinea Pigs Maximalisation Test.