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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
15 Nov – 15 Dec 2005
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
No periodically reliability checks were performed

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted in 1992
Deviations:
yes
Remarks:
The initial concentration of the 1st induction was reduced for the 2nd and 3rd induction. The reliability check was not performed every 6 months
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The test was performed in 2005 when the OECD Guideline 406 adopted in 1992 was the current version. According to this guideline "the Guinea Pig Maximisation Test (GPMT) [...] and the non-adjuvant Buehler Test are given preference over other methods".

Test material

Constituent 1
Reference substance name:
Glycine, N-methyl-, N-coco acyl derivs., sodium salts
EC Number:
263-193-2
EC Name:
Glycine, N-methyl-, N-coco acyl derivs., sodium salts
Cas Number:
61791-59-1
Molecular formula:
unspecified, UVCB substance
Test material form:
not specified
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 4179278

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: 12 months

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: SPF albino Crl:HA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, Kißlegg, Germany
- Females nulliparous and non-pregnant: yes
- Weight at study initiation: 336 - 389 g
- Housing: 2 or 3 animals per cage in macrolone cages, softwood sawdust bedding
- Diet: Altromin 3122 pelleted, Altromin, Lage, Lippe, Germany, ad libitum
- Water: domestic quality water, Vitamin C enriched, acidified to pH 2.5 with hydrochloric acid, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
1st induction: 100%
2nd and 3rd induction: 75%

Day(s)/duration:
0 - 14
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
50%
Day(s)/duration:
28
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10 (controls), 20 (in test group)
Details on study design:
RANGE FINDING TESTS: Preliminary irritation investigations were performed with two other animals to determine suitable concentrations for the induction and challenge application. Concentrations of the test item used were 25, 50, 75 and 100%. Based on the results, a concentration of 100% and 75% was selected for the induction phase and of 50% for the challenge phase.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: test material in water
- Control group: water
- Site: left flank
- Frequency of applications: every 7 days
- Duration: Days 0 – 14
- Concentrations: 100 and 75%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 28
- Exposure period: 6 h
- Test groups: test material in water and water
- Control group: test material in water and water
- Site: anterior part of the right flank (test substance) and posterior part of the right flank (vehicle)
- Concentrations: 50%
- Evaluation (hr after challenge): 24 and 48 h after patch removal
Challenge controls:
The control group is actually a challenge control.
Positive control substance(s):
no

Results and discussion

Positive control results:
The latest positive control study was performed in 2002. The positive control substance (100% alpha-hexylcinnamaldehyde) induced 65% positive responses, thus meeting the reliability criteria for the Buehler test (≥ 15% positive response). However, positive control studies shall be performed every six months according to OECD Guideline 406. Thus, the positive control study does not comply with the OECD Guideline 406.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Induction 0%; challenge: 50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
Induction: 100% and 75%; challenge: 50%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Induction: 0%; challenge: 50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Induction: 100% and 75%; challenge: 50%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
Slight or discrete erythema
Remarks on result:
no indication of skin sensitisation

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.
Executive summary:

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