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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:
weight of evidence
Study period:
05 Apr - 08 Apr 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Final report on the Safety Assessment of Cocoyl Sarcosine, Lauroyl Sarcosine, Myristoyl Sarcosine, Oleoyl Sarcosine, Stearoyl Sarcosine, Sodium Cocoyl Sarcosinate, Sodium Lauroyl Sarcosinate, Sodium Myristoyl Sarcosinate, Ammonium Cocoyl Sarcosinate, and
Author:
Cosmetic Ingredient Review Panel
Year:
2001
Bibliographic source:
Int J Toxicol 20( 1):1-14
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
no experimental 48 h reading performed
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium N-methyl-N-(1-oxotetradecyl)aminoacetate
EC Number:
250-151-3
EC Name:
Sodium N-methyl-N-(1-oxotetradecyl)aminoacetate
Cas Number:
30364-51-3
Molecular formula:
C17H33NO3.Na
IUPAC Name:
sodium N-methyl-N-(1-oxotetradecyl)aminoacetate
Test material form:
other: aqueous formulation

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: a USDA and FDRL approved supplier (no further information)
- Age at study initiation: young adults
- Weight at study initiation: 2-3 kg
- Housing: animals were housed individually in wire mesh bottom cages.
- Diet: NIH 09 Rabbit Ration (Zeigler Brothers, Inc., Gardners, PA, USA)
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Environment-controlled rooms per "Guide for the Care and Use of Laboratory Animals" (no further information).
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded
Vehicle:
unchanged (no vehicle)
Controls:
other: not required, untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
72 h
Reading time points: 0,5, 24 and 72 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: right and left dorsal side of the animal. The right dorsal side was abraded to penetrate the stratum corneum.
- Type of wrap if used: the test side was covered with a one square inch gauze patch, two single layers thick and held in place with a Micropore tape and was subsequently secured by a non-absorbant binder.

REMOVAL OF TEST SUBSTANCE
- The test areas were gently wiped using a soft clean gauze.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0.78
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0.44
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)

Any other information on results incl. tables

Table 1. Results of skin irritation study (intact skin).

Observation time Rabbit no.
1 2 3 4 5 6
Erythema Edema Erythema Edema Erythema Edema Erythema Edema Erythema Edema Erythema Edema
0.5 h 1 1 1 2 2 2 1 1 1 1 0 0
24 h 1 0 1 2 1 0 2 2 0 0 0 0
48 h No experimental data available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption)
72 h 0 0 1 0 1 0 1 0 0 0 1 0

Table 2. Calculation of mean scores (intact skin).

  Rabbit no.
1 2 3 4 5 6
Erythema Edema Erythema Edema Erythema Edema Erythema Edema Erythema Edema Erythema Edema
Mean value 24 + 48 + 72 h* 0.67 0.00 1.00 1.33 1.00 0.00 1.67 1.33 0.00 0.00 0.33 0.00

*No 48 h data are available: for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h).

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.

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