Ethylamine

Skin irritation / corrosion

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

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

Test material information

Constituent 1

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

Results

Results 1

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

Results 2

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.