Sodium N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 Oct - 17 Nov 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of oleoyl sarcosine with sodium hydroxide

IUPAC Name:

Reaction products of oleoyl sarcosine with sodium hydroxide

Test material form:

semi-solid (amorphous): gel

Remarks:

migrated information: paste

Details on test material:

- Name of test material (as cited in study report): Natriumoleoylsarkosinat, R-CO-N(CH3)-CH2-COONa
- Physical state: yellowish, creamlike
- Analytical purity: 100% (conditional on production the product still contains really approx. 5% sodiumoleat)
- Arrival of test item: 2004-09-16
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

other: LIttle russian, Chbb:HM(SPF)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: DIMEO Schonwalde GmbH, Schonwalde, Germany and stock Chbb:HM from Charles River Deutschland GmbH, Kisslegg, Germany
- Housing: during a pre-period of at least one week and throughout the experiment the rabbits were caged individually in PPO cages (floor area: 2576 cm²) with perforated floor.
- Diet: pelleted complete rabbit diet "Altromin 2123", ad libitum.
- Water: domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth, ad libitum

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:

shaved

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 mg

Duration of treatment / exposure:

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

Observation period:

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

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: anterior area of the animal
- Type of wrap if used: the patch was placed on the appropriate anterior test field and secured semi-occlusively with adhesive Gothaplast tape (2.5 cm).

REMOVAL OF TEST SUBSTANCE
- Washing: after the exposure time the patch was removed, the test field was marked and the treated skin was cleaned with mild soap and lukewarm water.
- Time after start of exposure:
Initial test: 3 min, 1 h and 4 h
Confirmatory test: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

2.33

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: scales were still apparent

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

Immediately after application, the animal used in the preliminary test showed a well defined erythema. 1, 24, 48 and 72 h after application, well defined to moderate to severe erythema were observed in all animals (see Table 1 + 2 under “Any other information on results incl. tables”).
24, 48 and 72 h after application: slight to moderate oedema were observed in all animals. After 1 h slight oedema was observed in one animal.
7 days after application: isolated scales were observed on the anterior left test field of one animal and thick, brown scales on the middle left test field and a thick, brown crust of scales on the whole posterior left test field. The remaining two animals showed large, white scales on the whole anterior left test fields.
14 days after application: scales were observed in two animals whereas no skin reactions were observed for the third animal.
21 days after application: one animal still showed isolated scales.

Other effects:

No further local or systemic effects were observed.

Any other information on results incl. tables

Table 1. Results of the initial irritation study.

Exposure time	Erythema formation observed [h]					Oedema formation observed [h]
	0	1	24	48	72	0	1	24	48	72
3 min	0	0	2	1	1	0	0	0	0	0
1 h	0	0	3	2	2	0	0	1	1	1

Table 2. Results of skin irritation study.

Observation time	Rabbit no.
	1		2		3
	Erythema	Edema	Erythema	Edema	Erythema	Edema
1 h	2	0	2	1	2	0
24 h	3	1	3	3	3	2
48 h	2	2	3	2	3	2
72 h	2	2	3	2	3	2
Mean value 24 + 48 + 72 h	2.33	1.67	3.0	2.3	3.0	2.0

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: Skin irrit 2, H315
DSD: Xi, R38