N-[3-(dimethylamino)propyl]oleamide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in accordance with OECD guideline 402 and GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-[3-(dimethylamino)propyl]oleamide

EC Number:

203-661-5

EC Name:

N-[3-(dimethylamino)propyl]oleamide

Cas Number:

109-28-4

Molecular formula:

C23H46N2O

IUPAC Name:

(9Z)-N-[3-(dimethylamino)propyl]octadec-9-enamide

Test material form:

other: liquid

Details on test material:

Batch: R 401/57
Purity: 78.2%
Color: reddish

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Supplier: RCC Ltd Laboratory Animal Services
Age at beginning of study: 8-9 weeks (males), 12-13 weeks (females)

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Application area: ca. 40 cm²
Application volume: 2.24 ml/kg body weight

Duration of exposure:

24 hours

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: at least 14 days
- Determination of body weight: shortly before test substance administration, weekly thereafter and on the last day of observation
- Necropsy with gross-pathology examination performed on the last day of the observation period

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

None occured.

Clinical signs:

Most of the animals showed transiently impaired general state, dyspnoea and piloerection (maximum incidence on day 1).
Local effects at the application site: erythema (grade 1-3), edema (grade 2), eschar formation (crust), squamation, squamation beyond the area of exposure, necrotic areas at the skin, brown discoloration of application site and skin obduration of application site.

Body weight:

Mean body weights of the animals were slightly decreased during the first post-exposure observation week but increased during the second week.

Gross pathology:

With exception of the changes in the skin no macroscopic pathologic abnormalities were detected in the animals examined on the last day of observation.

Any other information on results incl. tables

Nature and duration of local clinical signs (females)
Dose (mg/kg bw):	2000
Sex:	female
Administration	1
Number of animals:	5
Animal number:	100	101	102	103	104
Erythema, grade 2:	-	-	-	d12 -d14	d12 -d14
Erythema, grade 3:	d1	d1	d1	d1	d1
Edema grade 2:	-	-	-	d12-d14	d12 -d14
Application site, brown discolored:	d1-d14	d1-d14	d1-d8	d1-d8	d1-d12
Application site, skin obduration:	d1-d14	d1-d14	d1-d8	d1-d8	d1-d12
Necrotic areas at the skin:	d1-d14	d1-d14	d1-d8	d1-d8	d1-d12
Eschar formation (crust):	d5-d14	d4-d14	d4-d14	d4-d14	d4-d14
Moderate erythema, with wet areas:	d8-d14	d8-d14	d8-d14	d8d12-d14	d8-d12
Squamation:	-	-	-	d11-d13	d14
Squamation beyond area of exposure:	-	-	d6-d8	d6-d8	-

Nature and duration of local clinical signs (males)
Dose (mg/kg bw):	2000
Sex:	male
Administration	1
Number of animals:	5
Animal number:	105	106	107	108	109
Erythema, grade 1:	d12-d14	-	-	d14	-
Erythema, grade 2:	-	-	-	d11 -d13	d13 -d14
Erythema, grade 3:	d1	d1	d1; d7	d1	d1
Edema grade 2:	d12-d14	-	-	d11-d14	d12 -d14
Application site, brown discolored:	d1-d11	d1-d14	d5-d6	d5-d8	d5-d12
Application site, skin obduration:	d1-d11	d1-d14	d1-d8	d1-d8	d1-d12
Necrotic areas at the skin:	d1-d11	d1-d14	d1-d6	d1-d8	d1-d12
Eschar formation:	d4-d13	d1-d14	d1-d14	d4-d8	d4-d14
Moderate erythema, with wet areas:	-	-	d8-d14	-	-
Squamation:	d14	-	-	d11-d14	d4
Squamation beyond area of exposure:	-	d6-d7	-	-	-

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study the LD50 of 3-Dimethylaminopropyl-ölsäureamide after dermal application was found to be >2000 mg/kg body weight in rats. No classification according to Regulation (EC) No 1272/2008 (CLP) is required.

Executive summary:

The test substance 3-Dimethyl-aminopropyl-ölsäureamide was tested for acute dermal toxicity in the rat according to OECD guideline 402. A single dose of 2000 mg/kg body weight was applied to the clipped skin of five male and five female rats and

covered by a semi-occlusive dressing for 24 hours. The animals were observed for 14 days after application of the test substance. No mortality occurred. Most of the animals showed transiently impaired general state, dyspnoea and piloerection on study day 1. The following skin effects were observed at the application site: erythema (grade 1-3), edema (grade 2), eschar formation (crust), squamation, squamation beyond the area of exposure, necrotic areas at the skin, brown discoloration of application site and skin obduration of application site. Mean body weights of the female and male animals were slightly decreased during the first

post-exposure observation week but increased during the second week. Upon necropsy of the animals after 14 days, no pathological abnormalities were detected. Under the conditions of this study, the LD50 of 3-Dimethylaminopropyl-ölsäureamide after dermal application was found to be greater than 2000 mg/kg body weight. Thus, no classification according to Regulation (EC) No 1272/2008 (CLP) is required.