Diethylamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

28 July 2015

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: International Maritime Organization (I.M.O.) criteria

GLP compliance:

yes

Remarks:

additionally Quality assurance statement available

Test material

Test material information

Constituent 1

Reference substance name:

Diethylamine

EC Number:

203-716-3

EC Name:

Diethylamine

Cas Number:

109-89-7

Molecular formula:

C4H11N

IUPAC Name:

diethylamine

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- 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: Mohican Valley Rabbitry, Loudonville, Ohio
- Age at study initiation: young adult
- Weight at study initiation: 1.9- 2.2 kg
- Housing: individually housed in suspended stainless steel cages
- Diet: Agway Prolab Rabbit Ration, ad libitum
- Water: ad libitum
- Acclimation period: minimum of five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.3 - 26.5 °C
- Humidity (%): 35-70 %
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: 4/12/89 - 4/19/89

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 ml

Duration of treatment / exposure:

3 min

Observation period:

7 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: one and one-half inch square gauze patch
- Type of wrap if used: double layer of plastic wrap


REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test article wiped from the site with gauze soaked in distilled water
- Time after start of exposure: 3 min

SCORING SYSTEM: Draize system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 h - 48 - 72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 h - 48 h - 72 h

Score:

2.2

Max. score:

3

Reversibility:

fully reversible

Remarks:

7 days

Remarks on result:

positive indication of irritation

Any other information on results incl. tables

Table 1. Erythema score (animal1/animal2/animal3):

Exposure time	3 min	1 h	24 h	48 h	72 h	7 days
3 min	4/4/4	4/4/4	4/4/4	4/4/4	4/4/4	4/4/4

Table 2. Edema score (animal1/animal2/animal3):

Exposure time	3 min	1 h	24 h	48 h	72 h	7 days
3 min	1/1/1	2/2/2	2/3/3	2/2/2	2/2/1	0/0/0

The test substance produced dermal corrosion at all sites exposed to the test article. The dermal response was initially characterized by necrosis at the three minute scoring interval and progressed to eschar at one hour (2/3 rabbits) and 24 hours (3/3 rabbits). The eschar persisted throughout the remainder of the seven day study. A very slight edema was noted during the test period and diminished by test termination.

Applicant's summary and conclusion

Interpretation of results:

Category 1A (corrosive) based on GHS criteria

Conclusions:

The test substance caused corossion of the rabbit skin under the tested conditions.

Executive summary:

In a GLP compliant study the potential of the test item to cause skin corrosion/irritation was investigated with 3 New Zealand White rabbits. According to the International Maritime Organization (I.M.O.) criteria, 0.5 mL of the test substance was applied at the dorsal area of the trunk at a single site on the right flank after clipping. The exposure site was wrapped with a double layer of plastic wrap over the soaked gauze patch. After 3 min of exposure the plastic wrap and gauze patch were removed and washing of the residual test article was performed. Dermal reactions were observed at 3 min, 1 h, 24 h, 48 h, 72 h and 7 d after exposure initiation.

The test substance produced dermal corrosion at all sites exposed to the test article. The dermal response was initially characterized by necrosis at the three minute scoring interval and progressed to eschar at one hour (2/3 rabbits) and 24 hours (3/3 rabbits). The eschar persisted throughout the remainder of the seven day study. A very slight edema was noted during the test period and diminished by test termination.