Sodium N-methyl-N-(1-oxotetradecyl)aminoacetate

Skin irritation / corrosion

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

Reference

Reference 1

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 2

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

Test material information

Constituent 1

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

Results

Results 1

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)

Results 2

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.