N-[3-(dimethylamino)propyl]oleamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted on read-across substance according to OECD guideline and GLP; narrative description of nature and degree of irritation/corrosion is limited.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

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:

Fatty acids, tall-oil, compds. with N-[3-(dimethylamino)propyl]tall-oil amides

EC Number:

295-714-4

EC Name:

Fatty acids, tall-oil, compds. with N-[3-(dimethylamino)propyl]tall-oil amides

Cas Number:

92128-22-8

Molecular formula:

not available

IUPAC Name:

Fatty acids, tall-oil, compds. with N-[3-(dimethylamino)propyl]tall-oil amides

Test material form:

other: liquid

Details on test material:

- Test material form: dark brown liquid
- Purity: >95%
- Date of receipt: 28 June 2002
- Expiry date: July 2003
- Storage conditions: at room temperature
- pH: measured at CIT, approximately 8.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMAL:
- Source: CEGAV, Saint Mars d'Egrenne, France
- Age at study initiation: 2-4 months
- Weight at study initiation: 3.2 kg
- Housing: polystyrene cage (48.2 cm x 58 cm x 36.5 cm) equipped with a food container and a water bottle
- Diet (e.g. ad libitum): ad libitum, 110 pelleted diet (UAR, Villemoisson, Epinay-sur-Orge, France)
- Water (e.g. ad libitum): ad libitum, drinking water filtered by a FG Millipore membrane (0.22 micron)
- Acclimation period: at least 5 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL undiluted test substance

Duration of treatment / exposure:

4 hours (right flank), 3 minutes (left flank)

Observation period:

1 hour, 24, 48 and 72 hours after removal of the dressing

Number of animals:

1

Details on study design:

TEST SITE
Right and left flank of test animal (application for 4 hours and 3 minutes, respectively); both flanks were clipped the day before treatment, and clipping was repeated on day 2. Untreated skin served as control.

COVER
Test item was placed on dry gauze pads which were then applied to the clipped flanks. Test item and the gauze pad were held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.

REMOVAL OF TEST SUBSTANCE
After removal of the dressing, any residual test item was wiped off by means of a moistened cotton pad.

SCORING SYSTEM:
Erythema and eschar formation:
- no erythema: 0
- very slight erythema (barely perceptible): 1
- well-defined erythema: 2
- moderate to severe erythema: 3
- severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
Oedema formation
- no oedema: 0
- very slight oedema (barely perceptible): 1
- slight oedema (edges of area well-defined by definite raising): 2
- moderate oedema (raised approximately 1 millimetre): 3
- severe oedema (raised more than 1 millimetre and extending beyond area of exposure): 4

Any other lesions were noted.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

other: only one animal used

Time point:

other: 1 hour after removal of dressing

Score:

0

Max. score:

4

Remarks on result:

other: after 3 minutes exposure

Results 2

Irritation parameter:

edema score

Basis:

other: only one animal used

Time point:

other: 1 hour after removal of dressing

Score:

0

Max. score:

4

Remarks on result:

other: after 3 minutes exposure

Results 3

Irritation parameter:

erythema score

Basis:

other: only one animal used

Time point:

other: 1 hour after removal of dressing

Score:

0

Max. score:

4

Remarks on result:

other: after 4 hours exposure

Results 4

Irritation parameter:

edema score

Basis:

other: only one animal used

Time point:

other: 1 hour after removal of dressing

Score:

0

Max. score:

4

Remarks on result:

other: after 4 hours removal

Irritant / corrosive response data:

After a 3-minute or a 4-hour exposure, necrosis was noted at the application site 24 hours after removal of the dressing. The animal was then killed for ethical reasons. For details, see tables in section "any other information on results incl. tables".

Other effects:

A brown discoloration of the skin at the application sites was observed 1 hour after removal of the dressing after 3 minutes or 4 hours exposure.

Any other information on results incl. tables

Table 1. Irritation scores and other observations after 3 minutes exposure (scoring at 1 hour and 24 hours after removal of dressing).

Parameter	Scores
	1 hour	24 hours
Erythema	0	N
Oedema	0	LN
Other	C	*

h = hour

* = None

C = brown coloration of the skin

N = Necrosis

LN = scoring masked by necrosis

Table 1´2. Irritation scores and other observations after 4 hours exposure (scoring at 1 hour and 24 hours after removal of dressing).

Parameter	Scores
	1 hour	24 hours
Erythema	0	N
Oedema	0	LN
Other	C	*

h = hour

* = None

C = brown coloration of the skin

N = Necrosis

LN = scoring masked by necrosis

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the experimental conditions chosen, the test item is corrosive when applied topically to rabbits.

Executive summary:

The potential of the test item EMULSAMINE AT-O to induce skin irritation was evaluated in rabbits according to OECD Guideline 404 and in compliance with GLP. In the first instance, the test item was applied for periods of 3 minutes and 4 hours to a single male New Zealand White rabbit. As the test item showed corrosive properties on this first animal, the study was considered complete and the test item was not evaluated on other animals.

A single dose of 0.5 mL of the undiluted test item was applied to the closely-clipped skin of one flank. The test item was held in contact with the skin by means of a semi-occlusive dressing. Cutaneous reactions were observed approximately 1 hour and 24 hours after removal of the dressing.

After a 3-minute or a 4-hour exposure, necrosis was noted at the application site 24 hours after removal of the dressing. The animal was then killed for ethical reasons. It was concluded that, under the experimental conditions chosen, the test item is corrosive when applied topically to rabbits.