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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Principles of method if other than guideline:
according to Draize et al.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): diethylamine
- Physical state: clear liquid
- Storage condition of test material: Room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Mohican Valley Rabbitry, Loudonville, Ohio
- Age at study initiation: young adult
- Weight at study initiation: 1.9- .2 kg
- Housing: individually housed in suspended stainless steel cages
- Diet: Agway Prolab Rabbit Ration, ad libitum
- Water: water ad libitum
- Acclimation period: minimumof five days


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

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
3 min
Observation period:
14 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h - 48 - 72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
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

Any other information on results incl. tables

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


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

Diethylamine 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