(Z)-N-methyl-N-(1-oxo-9-octadecenyl)glycine, compound with 2,2',2''-nitrilotri(ethanol) (1:1)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

25 Mar - 09 Aug 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

lack of test material details

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

lack of test material details

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(Z)-N-methyl-N-(1-oxo-9-octadecenyl)glycine

EC Number:

203-749-3

EC Name:

(Z)-N-methyl-N-(1-oxo-9-octadecenyl)glycine

Cas Number:

110-25-8

Molecular formula:

C21H39NO3

IUPAC Name:

N-methyl-N-oleoylglycine

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Bancel (Albon, France)
- Age at study initiation: adult
- Weight at study initiation: 2.4-2.65 kg
- Housing: animals were housed individually in polystyrene cages, with perforated flooring.
- Diet: approximately 150 g per animal per day of complete pelleted rabbit maintenance diet (U.A.R. formula 112, U.A.R. Villemoisson, Orge, France)
- Water: softened and filtered mains drinking water, ad libitum
- Acclimation period: at least 21 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 21-59
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: 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:

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

Number of animals:

6 males

Details on study design:

TEST SITE
- Area of exposure: 6 cm² on the back and the flanks of the animal
- Type of wrap if used: The treated skin was covered with a square of 8-layer thick Codex hydrophilic gauze with an identical surface area and held in place by means of a semi-occlusive dressing (perforated adhesive tape applied onto a band of crepe gauze).
-Other: during exposure, animals were immobilised in restraining boxes.

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:

other: mean over 24, 48 and 72 h

Score:

2.89

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: Absence of hair on the whole application area was observed in all animals.

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Other effects:

All test animals showed burnt aspect of the skin from less than one quarter of the application area (4/6), about one quarter (1/6) to the whole application area (1/6), after 24 and 48h. At the 72 h reading time point all animals showed slight dryness of the skin at the application site.
Slight desquamation of the epidermis on the application area was observed in 2/6 animals and severe desquamation in 3/6 animals after 7 days. At this time point all animals showed slight dryness of the skin on the application area. Furthermore, at 7 days one animal showed burnt aspect on the whole application area. After 14 days absence of hair on the whole application area was apparent in all animals.

Any other information on results incl. tables

Table 1. Results of skin irritation study.

Observation time	Rabbit no.
	1		2		3		4		5		6
	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
1 h	2	2	2	1	2y	2	2	2	2	0	2	0
24 h	2y	2	2y	2	4u	2	4x	3	2y	1	2y	1
48 h	2y	2	2y	1	4us	2	4x	3	2y	2	2y	1
72 h	4xs	3	2ys	2	4us	2	4xs	3	2ys	3	2ys	1
Mean value 24 + 48 + 72 h	2,67	2,33	2,00	1,67	4,00	2,00	4,00	3,00	2,00	2,00	2,00	1,00

S: Slight dryness of the skin to the application area.

u: Burnt aspect on the whole application area.

x: Burnt aspect on about one quarter of the application area.

y: Burnt aspect on a surface less than one quarter of the application area.

Table 2. Results of skin irritation study after 7 and 14 days.

Observation time

Rabbit no.

1

2

3

4

5

6

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

7 days

4usd

2

2ysD

1

2Ts

1

4xsD

1

2ds

1

2DTs

0

14 days

0T

0

0T

0

0T

0

0T

0

0T

0

0T

0

D: Severe desquamation of the epidermis to the application area.

T: Absence of hair on the whole application area.

d: Slight desquamation of the epidermis to the application area.

s: Slight dryness of the skin to the application area.

u: Burnt aspect on the whole application area.

x: Burnt aspect on about one quarter of the application area.

y: Burnt aspect on a surface less than one quarter of the application area.

Applicant's summary and conclusion

Interpretation of results:

other: Skin irrit 2, H315. Classification according to Regulation (EC) No 1272/2008 (CLP/EU GHS).