Dimethyl(tetradecyl)amine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Test is done under GLP and following OECD Guidelines

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)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Decyldimethylamine

EC Number:

214-302-7

EC Name:

Decyldimethylamine

Cas Number:

1120-24-7

Molecular formula:

C12H27N

IUPAC Name:

N,N-dimethyldecan-1-amine

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.0-3.0 kg
- Housing: individually in metal cages
- Diet (ad libitum): Rabbit Diet, Preston Farmers Limited, New Leake, Boston, Lincolnshire, U.K.
- Water (ad libitum): drinking water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 13-21
- Humidity (%): 47-69
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

4 h

Observation period:

Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined, total obervation time: 14 days

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100
- Type of wrap if used: gauze patch secured in position with a strip of surgical adhesive tape (BLENDERM), wrapped in an elasticated corset (TUBIGRIP)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 h

SCORING SYSTEM:
according to Draize and guidelines

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24,48,72 h

Score:

2

Max. score:

4

Reversibility:

other: erythema fully reversible within 14 days, but other skin effects

Remarks on result:

other: effects after 14 days: keratinolysis, reduced re-growth of fur, straw-coloured crust

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24,48,72 h

Score:

2

Max. score:

4

Reversibility:

other: unclear due to other skin effects

Remarks on result:

other: effects after 14 days: dried blood, thickening of skin, scar tissue, straw-coloured crust

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24, 48, 72 h

Score:

2

Max. score:

4

Reversibility:

other: unclear due to other skin effects

Remarks on result:

other: effects after 14 days: dried blood, thickening of skin, scar tissue, straw-coloured crust

Results 4

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

other: 24, 48, 72 h

Score:

2

Max. score:

4

Reversibility:

other: unclear due to other skin effects

Remarks on result:

other: effects after 14 days: thickening of skin, scar tissue, straw-coloured crust

Results 5

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

other: 24, 48, 72 h

Score:

2

Max. score:

4

Reversibility:

other: unclear due to other skin effects

Remarks on result:

other: effects after 14 days: dried blood, thickening of skin, scar tissue, straw-coloured crust

Results 6

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

other: 24, 48, 72 h

Score:

2

Max. score:

4

Reversibility:

other: unclear due to other skin effects

Remarks on result:

other: effects after 14 days: keratinolysis, reduced re-growth of fur, thickening of skin, scar tissue, straw-coloured crust

Results 7

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24, 48, 72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: reactions extending beyond site of application

Results 8

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24, 48, 72 h

Score:

2.3

Max. score:

4

Reversibility:

other: unclear due to other skin effects

Remarks on result:

other: reactions extending beyond site of application

Results 9

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24, 48, 72 h

Score:

2.3

Max. score:

4

Reversibility:

other: unclear due to other skin effects

Remarks on result:

other: reactions extending beyond site of application

Results 10

Irritation parameter:

edema score

Basis:

animal #4

Time point:

other: 24, 48, 72 h

Score:

2

Max. score:

4

Reversibility:

other: unclear due to other skin effects

Remarks on result:

other: reactions extending beyond site of application

Results 11

Irritation parameter:

edema score

Basis:

animal #5

Time point:

other: 24, 48, 72 h

Score:

2.7

Max. score:

4

Reversibility:

other: unclear due to other skin effects

Remarks on result:

other: reactions extending beyond site of application

Results 12

Irritation parameter:

edema score

Basis:

animal #6

Time point:

other: 24, 48, 72 h

Score:

2

Max. score:

4

Reversibility:

other: unclear due to other skin effects

Remarks on result:

other: reactions extending beyond site of application

Irritant / corrosive response data:

Effects after 4 h of exposure:
Severe dermal responses were produced. The adverse skin reactions sometimes precluded accurate evaluation of erythema and oedema.
The reactions were identified as well-defined erythema, severe oedema, haemorrhage of the dermal capillaries, a brown discolouration of the epidermis, blanching of the skin, white raised areas of skin, scabbing, loss of skin elasticity, a dry straw-coloured crust (possible hyperkeratinisation), thickening of the skin, reduced re-growth of fur and glossy skin. Scar tissue, indicative of dermal corrosion was noted in five rabbits.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (corrosive)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study the test material was corrosive to the skin of rabbits

Executive summary:

Six New Zealand rabbits were treated with the test substance in an dermal irritation/corrosion study according to guidelines OECD 404 and EU B.4. The test substance produced erythema with a mean score of 2 and edema with a mean score of 2.2. After 4 h of exposure, severe dermal responses were produced. The adverse skin reactions sometimes precluded accurate evaluation of erythema and oedema. The reactions were identified as well-defined erythema, severe oedema, haemorrhage of the dermal capillaries, a brown discolouration of the epidermis, blanching of the skin, white raised areas of skin, scabbing, loss of skin elasticity, a dry straw-coloured crust (possible hyperkeratinisation), thickening of the skin, reduced re-growth of fur and glossy skin. Scar tissue, indicative of dermal corrosion was noted in five rabbits. Under the conditions of this study the test material was corrosive to the skin of rabbits.