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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:
09 Jan - 28 Feb 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted in 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
adopted in 1996
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A non-LLNA test is available that was performed prior to the current data requirements that are stipulated in Regulation (EC) No. 1907/2006. In accordance with the same Regulation, the data were included to avoid unnecessary testing.

Test material

Constituent 1
Chemical structure
Reference substance name:
Docosyl docosanoate
EC Number:
241-646-5
EC Name:
Docosyl docosanoate
Cas Number:
17671-27-1
Molecular formula:
C44H88O2
IUPAC Name:
docosyl docosanoate
Test material form:
solid

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Albino Dunkin Hartley, CRL:(HA)BR, SPF
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, Kisslegg, Germany
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: 334 - 348 g (pretest), 322 - 365 g (main test and control)
- Housing: Individually in Makrolon Type-4 cages with wire mesh tops and standard softwood bedding ('Lignocel', Schill AG, Muttenz, Switzerland)
- Diet : Provimi Kliba 3418 guinea pig breeding/maintenance diet, batch nos. 61/07 and 70107, containing Vitamin C (Provirni Kliba AG, Kaiseraugst, Switzerland), ad libitum
- Water: Community tap water from Füllinsdorf, ad libitum
- Acclimation period: Three days under laboratory conditions after health examination
- Indication of any skin lesions: Only healthy animals with no visible lesions were selected

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12

- IN-LIFE DATES: From: 09 Jan 2008 To: 28 Feb 2008

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
polyethylene glycol
Concentration / amount:
1% in PEG 300
Day(s)/duration:
Day 1
Adequacy of induction:
other: well tolerated systemically, selected because even lower concentrations (0.5 - 0.01%) caused the same skin reactions
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Concentration / amount:
50% in PEG 300
Day(s)/duration:
Day 8
Adequacy of induction:
other: highest attainable concentration which could be applied and well-tolerated systemically
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Concentration / amount:
50% in PEG 300
Day(s)/duration:
Day 22
Adequacy of challenge:
other: non-irritant and maximum concentration attainable
No. of animals per dose:
10 (test group), 5 (control)
Details on study design:
RANGE FINDING TESTS:
- Intradermal injection: Two animals were used to establish the concentration of the test substances for the main test. Four intradermal injections (0.1 mL/site) of a 1:1 (v/v) mixture of Freund's Complete
Adjuvant (FCA)/physiological saline were made into the shaved neck of the animals. Five days later intradermal injections (0.1 mL/site) were made into the clipped flank of animal 1 at concentrations of 5%, 3% and 1% of the test item in PEG 300. Seven days after the first pretest, a second pretest was conducted in the second animal. The intradermal injections were made into the clipped flank at concentrations of 0.5%, 0.3%, 0.1%, 0.05%, 0.03% and 0.01% test item in PEG 300. Dermal reactions were assessed 24 h post injection. Based on the pretest, the test item concentration of 1% was selected for intradermal induction in the main study.
- Epidermal induction: Four intradermal injections (0.1 mL/site) of a 1:1 (v/v) mixture of FCA/physiological saline were made into the shaved neck of two guinea pigs. Five days later both flanks of each animal were clipped and shaved and four patches of filter paper (3 x 3 cm) were saturated with 0.2 mL or 0.2 g of the test item at 50% (highest attainable concentration), 25%, 15% and 10% in PEG 300 and applied to the flanks under occlusive conditions. The dressings were removed after 24 h. Approx. 48 and 72 h after the epidermal application the skin reactions were observed. Based on the results obtained the concentration selected for induction and challenge in the main study was 50% and 50%, respectively.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)

Test group:
Intradermal (3 pairs of injections):
- Injection 1: a 1:1 mixture (v/v) FCA/physiological saline
- Injection 2: test substance in PEG 300
- Injection 3: test substance in a 1:1 mixture (v/v) FCA/water
Epicutaneous: test substance in PEG 300

Control:
Intradermal (3 pairs of injections):
- Injection 1: a 1:1 mixture (v/v) FCA/physiological saline
- Injection 2: PEG 300
- Injection 3: 1:1 (w/w) mixture of PEG 300 in a 1:1 mixture (v/v) FCA/physiological saline
Epicutaneous: PEG 300

- Site: scapular area (approximately 6 x 8 cm) (intradermal + epicutaneous)
- Frequency of applications: every 7 days
- Duration: Days 1 - 8
- Concentrations: intradermal 1%, epicutaneous 50%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 22
- Exposure period: 24 h
- Test groups: test substance and vehicle
- Control group: test substance and vehicle
- Site: Example: left flank (test substance) and right flank (vehicle)
- Concentrations: Example: 50%
- Evaluation (h after challenge): 48 and 72 h
Challenge controls:
The control group is actually a challenge control
Positive control substance(s):
yes
Remarks:
alpha-Hexylcinnamaldehyde (intradermal: 0.3% in PEG 300, epicutaneous: 10% in PEG 300, challenge: 3% in PEG 300)

Results and discussion

Positive control results:
As demonstrated in RCC Study Number B59455, the positive control substance (alpha-Hexylcinnamaldehyde, 3% in PEG 300) induced positive reactions in 2/10 animals (20%) at the 24 h reading and in 6/10 animals (60%) at the 48 h reading, thus validating the Guinea Pig Maximistion Test.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50% in PEG 300
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No signs of toxicity observed
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50% in PEG 300
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No signs of toxicity observed
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50% in PEG 300
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No signs of toxicity observed
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50% in PEG 300
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No signs of toxicity observed
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
3% in PEG 300
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
No signs of toxicity observed
Remarks on result:
positive indication of skin sensitisation
Remarks:
RCC Study B59455
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
3% in PEG 300
No. with + reactions:
6
Total no. in group:
10
Clinical observations:
No signs of toxicity observed
Remarks on result:
positive indication of skin sensitisation
Remarks:
RCC Study B59455

Any other information on results incl. tables

Table 1: Skin Reactions after the Challenge Procedure

  first reading 24 h second reading 48 h
 positive / total   positive / total 
% positive of total % positive of total
CONTROL GROUP
Test substance, 50 % in PEG 300 (left flank) 0 / 5  0 / 5 
0 0
PEG 300 onJy (right flank) 0 / 5  0 / 5 
0 0
TEST GROUP
Test substance, 50 % in PEG 300 (left flank) 0 /10 0 / 10
0 0
PEG 300 only (right flank) 0 / 10 0 / 10
0 0

No signs of toxicity were evident in the guinea pigs of the control or test group. No deaths occurred.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
A reliable study conducted in accordance with OECD guideline 406 and GLP found the test material to be non-sensitising to the skin of guinea pigs in a maximisation test based on Magnusson and Kligman. No signs of toxicity were evident in the guinea pigs of the control or test group and no deaths occurred.