Dimethyl(octyl)amine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 28.12.95 to 23.5.96

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: There are not desviations from the recommended guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

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:

Dimethyl(octyl)amine

EC Number:

230-939-3

EC Name:

Dimethyl(octyl)amine

Cas Number:

7378-99-6

Molecular formula:

C10H23N

IUPAC Name:

dimethyl(octyl)amine

Details on test material:

- Physical state: colourless liquid
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Froxfield SPF Rabbits, Broadway Farm, Froxfield, Hampshire, England
- Age at study initiation: 9-11 weeks
- Weight at study initiation: 2.2-2.3 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-23
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5mL

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours.
Days 7, 10, 13 and 16

Number of animals:

3 animals

Details on study design:

TEST SITE
- Area of exposure: 3x2 cm
- Type of wrap if used: gauze patch


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 (injury 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 mm): 3
Severe oedema (raised more than 1 mm and extending beyong the area of exposure): 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

4

Reversibility:

not reversible

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

1.3

Reversibility:

not reversible

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24, 48 and 72 hours

Score:

4

Reversibility:

not reversible

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24, 48 and 72 hours

Score:

1.7

Reversibility:

not reversible

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24, 48 and 72 hours

Score:

4

Reversibility:

not reversible

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24, 48 and 72 hours

Score:

1.7

Reversibility:

not reversible

Any other information on results incl. tables

Animal nº and sex	Erythema		Oedema
	Test	Control	Test	Control
1º animal	4.0	0..0	1.3	0.0
2º animal	4.0	0.0	1.7	0.0
3º animal	4.0	0.0	1.7	0.0

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this test and the criteria of the EEC, the substance was classified as "irritant" to the skin.

Executive summary:

The potencial of the substance to cause inflammatory or corrosive changes upon first contact with skin was assessed by semi-occluded application of 0.5mL of the test material to the closely-clipped dorsa of three New Zealand White rabbits for four hours. Dermal reactions were assessed 1, 24, 48 and 72 hours after removal of the dressings and on Days 7, 10, 13 and 16.

Because of the significant reactions seen at the end of the observation period, two of the animals were killed following this examination and the test sites were excised and examined in cross section. This examination revealed thickened skin in both animals, but not full thickness destruction of the skin.

Under the conditions of this test and the criteria of the EEC, the substance was classified as "irritant" to skin.