Glycine, N-methyl-, N-coco acyl derivs., sodium salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004-11-09 to 2004-11-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

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:

Not applicable

IUPAC Name:

disodium 2-(N-methyldodecanamido)acetate 2-(N-methyltetradecanamido)acetate

Test material form:

not specified

Test animals

Species:

rabbit

Strain:

other: SPF albino rabbits of the stock Chbb:HM

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: DIMED Schönwalde GmbH, Schönwalde, Germany; Charles River Deutschland GmbH, Kißegg, Germany
- Age at study initiation: 15-24 months
- Weight at study initiation: 2200-3100 g
- Housing: three female rabbits were caged individually in a polyphenyl (PPE) cage
- Diet: pelleted Altromin 2123, Lage, Lippe, ad libitum
- Water: (tap/filtered) water, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 55±15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

other: untreated site of the same animal served as control

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

Initial test: 3 min, 1 and 4 h
Confirmatory test: 4 h

Observation period:

14 days
Reading time points: 1, 24, 48, 72 h and 7 and 14 days

Number of animals:

3 females

Details on study design:

TEST SIDE:
- Area of exposure: 6.25 cm² on the left side of the back
- Type of wrap: The treated skin was covered with adhesive Gothaplast tape (2.5 cm)

REMOVAL OF TEST SUBSTANCE:
- Washing: Residual test material was removed with mild soap and lukewarm water.
- Time after start of exposure: 3 min, 1 and 4 h

SCORING SYSTEM:
Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

- Animal #1 used in the initial test showed a well-defined erythema on the posterior left test field immediately after the application.
- 1 h after the termination of exposure a well-defined erythema was observed on the posterior left test field of animal #1. Animal #2 showed a well-defined erythema on the anterior left test field, whereas a very slight erythema was observed on the anterior left test field of animal #3.
- 24, 48 and 72 h after the termination of exposure animal #1 showed a very slight erythema on the posterior left test field. A well-defined erythema and a very slight oedema were observed on the anterior left test field of animal #2. Animal #3 showed no skin reactions.
- 7 days after the termination of exposure small, white scales were still observed on approximately 60% of the anterior left test area of animal #2, whereas animal #1 showed no skin reactions anymore.
- 14 days after the termination of exposure animal #2 was free of any signs of skin irritation, too.
- The mean value for erythema and oedema formation calculated from these individual scores was 1.0 and 0.3 respectively.

Any other information on results incl. tables

Table 1: Summary of erythema and edema scores

Observation time	Rabbit No.
	1		2		3
	Erythema	Edema	Erythema	Edema	Erythema	Edema
1 h	2	0	2	0	1	0
24 h	1	0	2	1	0	0
48 h	1	0	2	1	0	0
72 h	1	0	2	1	0	0
Mean value 24 + 48 + 72 h	1	0	2	1	0	0
Mean value 24 + 48 + 72 h (all animals)	1	0

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.