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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
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 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted in 2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
adopted in May 2008
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N-(1-oxooctadecyl)sarcosine
EC Number:
205-539-7
EC Name:
N-(1-oxooctadecyl)sarcosine
Cas Number:
142-48-3
Molecular formula:
C21H41NO3
IUPAC Name:
N-methyl-N-stearoylglycine
Test material form:
other: solid

Test animals

Species:
rabbit
Strain:
other: SPF albino of the stock Chbb:HM
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, Kißlegg, Germany
- Age at study initiation: approx. 20-21 months
- Weight at study initiation: 2.7-2.9 kg
- Housing: animals were caged individually in PPO caged with perforated floor
- Diet: pelleted complete rabbit diet “Altromin 2123”, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least one week

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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g


Duration of treatment / exposure:
4 h (confirmatory test)
Observation period:
14 days
Reading time points: 1, 24, 48, and 72 h and 7 and 14 days
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: anterior right field of the back of each rabbit
- Type of wrap if used: 16- layer gauze patch (2.5 x 2.5 cm) secured semi-occlusively with adhesive Gothaplast tape (2.5 cm wide) and fixed with Gothaplast tape (5 cm wide) loosely wound around the trunk of the animals.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated skin was cleaned with mild soap and lukewarm water.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize score system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all three animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
One animal used in the initial test, showed a well-defined erythema and a very slight edema on the posterior right test field immediately after the application.
1 h after the termination of exposure a well-defined erythema and a very slight edema were noted on the posterior right test field of the same animal. Two further animals displayed a very slight erythema on the anterior right test field.
24, 48 and 72 h after the termination of exposure a well-defined erythema was observed on the posterior right test field of the first animal. A second animal showed a very slight erythema on the anterior right test field, whereas a well-defined erythema was observed on the anterior right test field of the third animal.
7 days after the termination of the application the first animal showed large scales in a middle-grade on the whole posterior right test field. Slight scurf was observed on the anterior right test field of the second and third animals.
14 days after the termination of application the first animal showed slight scurf on then whole posterior right test field. Isolated scales were observed on the anterior right test field of the second animal, whereas the third animal was free of any signs of skin irritation.

Applicant's summary and conclusion

Interpretation of results:
other: Skin irrit. 2, H315. Classification according to Regulation (EC) No. 1272/2008 (CLP/EU GHS).