Dodecylamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to OECD Guideline 404 and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

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:

Dodecylamine

EC Number:

204-690-6

EC Name:

Dodecylamine

Cas Number:

124-22-1

Molecular formula:

C12H27N

IUPAC Name:

dodecan-1-amine

Details on test material:

- Name of test material (as cited in study report): Genamin 12R 100 D

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Abbaye de Bellefontaine (49122 Bégrolles en Mauges, France)
- Age at study initiation: about 3 -5 months
- Weight at study initiation: 2.6 +- 0.1 kg
- Housing: conventional air-conditioned rooms, individually in polycarbonate cages. Each cage was equipped with a food container and a water bottle
- Diet (e.g. ad libitum): ad libitum (certified pellet Rabbit diet: lapins entretien Reference 112 C; U.A.R. 91360 Villemoisson-sur-Orge, France)
- Water (e.g. ad libitum): ad libitum (tap-water, filtered by membrane of .22micron (millipore)
- Acclimation period:
- min. 7 days
- daily observation during acclimation period
- preventive treatment for coccidiosis by administration of a Mucoxid solution at the dose level of 140 mg/kg/d (Veda-Cogla, 45140 Saint Jean de l a Ruelle, France) to their drinking water fpr 5 days during acclimatization period



ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-3 °C
- Humidity (%): 50 +-20 %
- Photoperiod (hrs dark / hrs light): 12/12
- incoming non-recylced air was filtered

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): 500 mg

Duration of treatment / exposure:

3 min
Then test substance was removed from the skin with water (3 animals) or with 3 % acetic acid solution followed by rinsing with water (3 animals)

Observation period:

14 days

Number of animals:

6 males (3 animals rinsed with water, 3 animals rinsed with 3% acetic acid solution)

Details on study design:

TEST SITE
- Area of exposure: 6 cm^2
- % coverage: 100 %
A dose of 500mg was applied to a Codex hydrophilic gauze patch of 6cm^2. this was applied to the right flank of each animal. The left flank which remains untreated served as a control


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with tap water or 3% acetic acid solution followed rinsing with water
- Time after start of exposure: 3 min.


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 (lesion in depth).........4

Oedema
No oedema...................................................................................................................................0
very slight oedema (barely perceptible)..................................................................................1
slight oedema (edges of area well defined by definite raising)............................................2
moderate oedema (raised approximately 1mm)....................................................................3
severe oedema (raised more than 1mm and extending beyond area of exposure.........4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 1 hour

Score:

2

Max. score:

2

Reversibility:

not reversible

Remarks:

necrosis noted from 24 h reading time point

Remarks on result:

other: 3 minute exposure followed by rinsing with water

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 1 hour

Score:

1

Max. score:

1

Reversibility:

not reversible

Remarks:

necrosis noted from 24 hour reading time point

Remarks on result:

other: 3 minute exposure followed by rinsing with water

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 1 hour

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: 3 minute exposure followed by rinsing with water

Results 4

Irritation parameter:

edema score

Remarks:

overall

Basis:

mean

Remarks:

all animals

Time point:

other: 24h / 48h / 72h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: necrosis noted from 24 hour reading time point proved to be reversible in only one animals

Remarks on result:

other: 3 minute exposure followed by rinsing with water

Results 5

Irritation parameter:

erythema score

Remarks:

overall

Basis:

mean

Remarks:

all animals

Time point:

other: 24h / 48h / 72h

Score:

3.33

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: 3 minute exposure followed by rinsing with 3% acetic acid

Results 6

Irritation parameter:

edema score

Remarks:

overall

Basis:

mean

Remarks:

all animals

Time point:

other: 24h / 48h / 72h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: 3 minute exposure followed by rinsing with 3% acetic acid

Irritant / corrosive response data:

The test material proved to be corrosive following a 3 minute exposure period with subsequent rinsing with water. However, severe irritating but no corrosivity was observed when rinsing was performed with 3% acetic acid solution instead of water.

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material Genamin 12R 100D proved to be corrosive to skin following an exposure period of 3 minutes and subsequent rinsing with water. However, when rinsing was performed with 3% acetic acid solution instead of water, severe irritating effects but no corrosivity was observed.

Executive summary:

In a GLP conform study, Genamin 12R 100 D was tested for skin irritation / corrosion according to OECD test guideline 404. for this 0.5 g of undiluted Genamin 12R 100D was applied semi-occlusively for 3 minutes to the shaved skin of six New Zealand White rabbits. To examine whether the rinsing procedure may have an influence on the skin irritative properties of this highly alkaline product, subsequent rinsing was performed with water (3 animals) and 3% acetic acid solution followed by water (3 animals) The skin of all animals then was examined 30 minutes, 1 hour, 24, 48 and 72 hours post exposure. Since effects were still present after 72 hours, additional readings were performed up to day 14.

One hour after removal of the dressing, the cutaneous reactions were marked; a slight to moderate erythema and a severe oedema were observed. No difference was noted between the two rinsing procedures for the animals.

An epidermal necrosis was noted quickly in the animals rinsed with water (24 h), which appeared delayed on Day 4 (1 animal) and 5 (2 animals) when the skin was rinsed with a 3% acetic acid solution, then water. Recovery developed in all animals rinsed with acetic acid solution. The skin was normal but dry in 2 animals on Day 10 and in the last animal on Day 14, when rinsing was performed with a 3% acetic acid solution, when water. The recovery occurred only in 1 animal when rinsed with water on Day 14. An epidermal necrosis was still present in 2 out of 3 animals rinsed with water at the end of the observation period

No oedema was observed in the animals from Day 7, for both rinsing procedures

Under our experimental conditions, the test substance Genamin 12R 100 D was corrosive. Severe cutaneous reactions leading to epidermal necrosis was seen earlier with rinsing the skin with water than with rinsing with 3% acid solution, then water. This latter procedure allowed a more rapid replacement of the necrotized epidermis than the former; this took 10 and 14 days respectively. Oedema which was severe in all animals after application of the test substance disappeared completely within 7 days. Based on the criteria laid down in the Directive 83/467/EEC, Genamin 12R 100 D has to be labelled as corrosive (C) with the designation R 35 — causes severe burns.