13-Docosenamide, N-[3-(dimethylamino)propyl]-, (13Z)-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 10 December 2008 to 11 February 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study without any restriction

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

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

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Erucamidopropyl dimethylamine

IUPAC Name:

Erucamidopropyl dimethylamine

Constituent 2

Reference substance name:

13-DOCOSENAMIDE, N-[3-(DIMETHYLAMINO)PROPYL]-, (13Z)-

EC Number:

604-714-9

Cas Number:

149968-48-9

Molecular formula:

not applicable (a generic molecular formula cannot be provided for this UVCB substance)

IUPAC Name:

13-DOCOSENAMIDE, N-[3-(DIMETHYLAMINO)PROPYL]-, (13Z)-

Test material form:

other: solid lightbeige

Details on test material:

- Storage condition of test material: at room temperature, light protected

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories B.V, The Netherlands
- Age at study initiation: Males: 18 weeks / Females: 15 weeks
- Weight at study initiation: Males: 2598g / Females: 2235-2509g
- Housing: individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood Blocks and haysticks 4642 were provided for gnawing.
- Diet (e.g. ad libitum): Pelleted standard Provimi Klibba 3418 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): communitu tap water, ad libitum
- Acclimation period: 4-5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12, music during the daytime period

IN-LIFE DATES: From: To: 10 to 26 December 2008

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Remarks:

the test item was moistened with approximately 0.5 mL of purified water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g of test item (powder) was weighed and moistened with approx. 0.5 mL of purified water before application
- Concentration (if solution): not applicable

VEHICLE
Not applicable

Duration of treatment / exposure:

4 hours

Observation period:

10 days

Number of animals:

1 male and 2 females

Details on study design:

TEST SITE
- Area of exposure: left flank
- % coverage: 2.5 x 2.5 cm
- Type of wrap if used: adhesive hypoallergenic aerated semiocclusive dressing and a restrainer bandage wrapped around the abdomen

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the skin was flushed with lukewarm tap water to clean the application site
- Time after start of exposure: 4h

SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: Overall 24, 48, 72hrs for each animal

Score:

> 0 - <= 2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Mean individual score at 24, 48, 72hrs: 2.0/1.7/0.0

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: Overall 24, 48, 72 hrs for each animal

Score:

> 0 - <= 0.7

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Mean individual score at 24, 48, 72 hrs: 0.0/0.7/0.0

Irritant / corrosive response data:

One hour after test item exposure a very slight erythema was observed in the first treated female and in the male which progressed into a well-defined erythema at the 24-hour reading and persisted as well-defined or very slight up to the 72-hour reading in both animals. A very slight swelling was recorded in the first treated female 24 to 48 hours after removal of the dressing. Scaling was present on the skin of the male on day 7. See details in Table 7.3.1/1.

Other effects:

no other effects

Any other information on results incl. tables

Table 7.3.1/1:Irritant/corrosive response data for each animal at each observation time after the topical application of the test substance on skin

Score at time point after the removal of the dressing / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 4
1h	1/1/0	0/0/0
24h	2/2/0	0/1/0
48h	2/2/0	0/1/0
72h	2/1/0	0/0/0
7 days	0/0/0	0/0/0
10 days	0/0/0	0/0/0
Average 24h, 48 and 72h	2.0/1.7/0.0	0.0/0.7/0.0
Reversibility*	c	c
Average time (day) for reversion**	10 (scaling in male until day 7)	7

 

 *) Reversibility: c. = completely reversible;= not completely reversible; n. = not reversible

**): correspond to the last day for which skin irritation signs in the last animal were observed

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, Erucamidopropyl dimethylamine is slightly irritating to the skin but the scores obtained are not sufficient for classification as a skin irritant according to the classification criteria of the Regulation (EC) 1272/2008 (CLP) and the Directive 67/548/EEC.

Executive summary:

In a dermal irritation study performed according to the OECD guideline No. 404/EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion) and in compliance with the GLP, 3 New Zeland Albino rabbits (one male and two females), were dermally exposed to 0.5 g of undiluted Erucamidopropyl dimethylamine (purity > 99%).

Prior to the topical application, the skin of the left flank of the rabbit was prepared with a clipper to remove the hair. 0.5 g of the test substance was placed on a surgical gauze patch and was moistened with 0.5 mL of purified water and then applied on the skin. Then the test site was covered with a semi occlusive dressing for 4 hours. Then the dressing was removed and the skin was flushed with water to clean the application site. Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 hrs, 7 and 10 days after the end of the topical application of the test patch.  

The mean individual scores calculated within 3 scoring times (24, 48 and 72 hrs) were 2.0/1.7/0.0 for erythema and 0.0/0.7/0.0 for edema. One hour after the end of test item exposure a very slight erythema was observed in the first treated female and in the male which progressed into a well-defined erythema at the 24-hour reading and persisted as well-defined or very slight up to the 72-hour reading in both animals. A very slight swelling was recorded in the first treated female 24 to 48 hours after removal of the dressing. Scaling was present on the skin of the male on day 7.

No abnormal findings were observed on the treated skin of both animals, which exhibited erythema and/or edema, 7 or 10 days after the end of the treatment.

Under the test conditions, Erucamidopropyl dimethylamine is slightly irritating to the skin but the scores obtained are not sufficient for classification as a skin irritant according to the classification criteria of the Regulation (EC) 1272/2008 (CLP) and the Directive 67/548/EEC. This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.