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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
Study period:
13 Dec 1988 - 15 May 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: International Maritime Organization (I.M.O.) criteria
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
28 July 2015
Deviations:
yes
Remarks:
7 d observation period (OECD: 14 d), no initial test with 1 animal
GLP compliance:
yes
Remarks:
additionally Quality assurance statement available

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethylamine
EC Number:
200-834-7
EC Name:
Ethylamine
Cas Number:
75-04-7
Molecular formula:
C2H5NH2
IUPAC Name:
ethanamine
Details on test material:
- Name of test material (as cited in study report): Ethylamine
- Analytical purity: no data
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: C-1324
- Purity: 70%

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
- Weight at study initiation: 2.1 - 2.3 kg
- Housing: Single-housing
- Diet: Agvay Prolab Rabbit Rations, ad libitum
- Water: Ad libitum
- Acclimation period: Minimum of 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 65-78 °F
- Humidity (%): 35-70%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 4/6/89 To: 4/13/89

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 mL
- Concentration (if solution): 70%


Duration of treatment / exposure:
3 min
Observation period:
- The test site was immediately graded for dermal reactions by a modified Draize method
- The test sites were also graded a 1, 24, 48, and 72 hours, and 7 days
Number of animals:
3 animals
Details on study design:
TEST SITE
- Area of exposure: Dorsal area of the trunk, single site on the right flank
- Type of wrap if used: Double layer of plastic wrap over a gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Wiping with gauze soaked in distilled water

OBSERVATION TIME POINTS: 1, 24, 48, 72 h, 7d

SCORING SYSTEM:
- Dermal irritation grading system (Score 0 to 4)
- Irreversible alterations (necrosis, ulceration, scabbing)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
1.4
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Highly corrosive
Other effects:
- Dermal corrosion at all exposed sites
- The dermal response was initially characterized by necrosis at the three-minute and one-hour scoring intervals and progressed to eschar (scab) at 24 hours post-dose
- The eschar persisted through the remainder of the seven-day study. During the test-period, very slight to slight edema, which diminished by the end of the study, was noted

Any other information on results incl. tables

Table 1: Erythema and eschar formation

Erythema - Average dermal irritation scores - 3 minute exposure

Time

Average

Note

3 min

4.00

Necrosis (all)

1 h

4.00

Necrosis (all)

24 h

4.00

Necrosis (1/3), Eschar (all)

48 h

4.00

Necrosis (1/3), Eschar (all)

72 h

4.00

Necrosis (1/3), Eschar (all)

7 d

4.00

Necrosis (1/3), Eschar (all), Exfoliation (1/3)

14 d

4.00

Eschar (all), Eschar exfoliation (all)

4 = severe erythema (beet redness) to slight eschar formations (injuries in depth)

Table 2: Edema formation

Edema

Average

3 min

1.33

1 h

2.0

24 h

1.67

48 h

1.67

72 h

1.33

7 d

0

1 = very slight edema, 2 = slight edema

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, 50 mL of the 70% solution 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 dermal response was initially characterized by necrosis (after 3 min, 1 h) and progressed to irreversible eschar formation at 24 h. Moreover, the formation of very slight to slight edema (reversible) was noted during the test.

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