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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004-09-21 to 2004-10-20

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.

EC Number:

270-156-4

EC Name:

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

Cas Number:

68411-97-2

Molecular formula:

C15H29NO3 to C17H33NO3

IUPAC Name:

2-(N-methyldodecanamido)acetic acid; 2-(N-methyltetradecanamido)acetic acid

Test animals

Species:

rabbit

Strain:

other: SPF albino rabbit 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: 56 weeks
- Weight at study initiation: 2400 g
- Housing: individual female rabbit was caged in a polyphenyl ether (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 and 1 h

Observation period:

Initial test: 28 days
Reading time points: 1, 24, 48, 72 h and 7, 14, 21 and 28 days

Number of animals:

1 female

Details on study design:

TEST SIDE:
- Area of exposure: 6.25 cm² on the right 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, 1h

SCORING SYSTEM:
Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 1 h

Score:

4

Max. score:

4

Reversibility:

fully reversible

Remarks:

after 28 days

Remarks on result:

other: skin has been washed 1 h p.a. due to severe immediate effects

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible

Remarks:

after 28 days

Remarks on result:

other: skin has been washed 1 h p.a. due to severe immediate effects

Results 3

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 1 h

Score:

3

Max. score:

4

Reversibility:

fully reversible

Remarks:

after 28 days

Remarks on result:

other: skin has been washed 1 h p.a. due to severe immediate effects

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible

Remarks:

after 28 days

Remarks on result:

other: skin has been washed 1 h p.a. due to severe immediate effects

Irritant / corrosive response data:

- The animal showed a very slight erythema on the middle and posterior right test field immediately after the application, 1h and 24 h after the termination of exposure a severe erythema to eschar formation and a moderate oedema was observed in the middle right test field as well as a severe erythema to eschar formation and a slight oedema on the posterior right test field.
- 48 h after the termination of exposure the animal showed a severe erythema to eschar formation as red-brownish discoloration and a severe oedema reaching widely beyond the patch area of the middle and posterior right test field.
- 72 h after the termination of exposure a severe erythema to eschar formation and a severe oedema were observed on the middle and posterior right test field of the animal.
- 7 days after the termination of exposure the animal showed a markedly elevated, brownish crust of scales being partially dropped off on the whole area of the middle and posterior right test field.
- 14 days after the termination of exposure granulation tissue was observed underneath the dropped off crust of scales on the middle and posterior right test field.
- 21 days after the termination of exposure the affected skin areas of the middle and posterior test field of the animal were healed almost completely.
- 28 days after the termination of exposure no pathological changes were macroscopically discernible anymore at the animal

Any other information on results incl. tables

Individual erythema and oedema scores

Animal No./ weight in kg	Exposure	Test field	Erythema formation					Oedema formation
			0	1	24	48	72	0	1	24		48	72
1 / 2,4	3 min	anterior ri.	0	0	0	0	0	0	0		0	0	0
	1 h	median ri.	1	4	4	4	4	0	3		3	4a)	4
	Instead of 4 h, stop after approx.. 1 h	posterior ri.	1	4	4	4	4	0	2		2	4a)	4

Remark 4a): Red-brownish discoloration of the patch area and oedema reaching beyond the patch area widely

Applicant's summary and conclusion

Interpretation of results:

other: Skin corr. 1B, H314. Classification according to Regulation (EC) No. 1272/2008 (CLP/EU GHS).