Ethylamine

Endpoint summary

Description of key information

The application of the aqueous solution of ethylamine caused corrosion of rabbit skin within 3 min of exposure and irreversible eye damage to the rabbit eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

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

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

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

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)

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

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

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: meets generally accepted scientific principles, acceptable for assessment

Principles of method if other than guideline:

Eye injury in rabbits was recorded in a 10-grade ordinal series based upon the degree of corneal necrosis that results from instillation of various volumes and concentrations of chemical. Grade 1 indicates at most a very small area of necrosis resulting from 0.5 mL of undiluted chemical in the eye. Grade 5 indicates a so-called severe burn from 0.005 mL, and Grade 10 indicates a severe burn from 0.5 mL of a 1% solution in propylene glycol.

GLP compliance:

no

Species:

rabbit

Strain:

not specified

Vehicle:

other: propylene glycol

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Concentration (if solution): Undiluted, or as 1, 5, 15% solution in propylene glycol

Duration of treatment / exposure:

Single application

Observation period (in vivo):

no data

Number of animals or in vitro replicates:

no data

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: no data

Score:

9

Max. score:

10

Reversibility:

not reversible

The undiluted compound causes severe damage as do also 15 and 5 % dilutions in propylene glycol. A 1% solution causes only slight injury.

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Severe damage to the rabbit eye was recorded in a study conducted with rabbits which where treated with the undiluted test compound and a 5% and 15% dilution in propylene glycol.

Executive summary:

Eye injury in rabbits was recorded in a 10-grade ordinal series based upon the degree of corneal necrosis that results from instillation of various volumes and concentrations of the chemical. The undiluted compound caused severe damage as did also 15% and 5% dilutions in propylene glycol. A 1% solution caused only slight injury.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Additional information

Skin irritation:

In a GLP compliant study (Hoechst, 1989; reliability score: 1) similar to OECD 404, 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.

A second study (Union Carbide, 1986; reliability score 2) was performed to determine the realtive dermal irritancy and corrosivity of the test article after topical application to the intact skin of albino rabbits. One male animal was treated for 3 min and 30 min with 0.5 mL undiluted test substance (ca. 70% solution) under a gauze patch at 2 seperate test sites. The animal was anesthetized before test substance appliaction. A well-defined erythema and very slight edema were observed 3 minutes post-exposure (erythema = 2, edema = 1). The skin became dark and necrotic at the 60 minute exposure test site (erythema = 4, edema = 1, after 30 min). Dead due to anesthetic approximately 30 min post-treatment occured.

A corrositex study similar to OECD 435 (Harbell, 1994; reliability score 2) was conducted to evaluate the potential of corrosivity of 3 test item solutions (70%, 65%, 25%) as measured by their penetration through a calibrated biobarrier into a chemical detection system. 500 mg or 500 µL of the test substances were added to the membrane disc. Each test solution was analyzed 6 times. The mean breakthrough times amounted to less than 3 minutes for the tested 70% and 65% solutions and 3.47 for the 25% solution. As 2 replicates of the lowest concentrated solution of the test material broke through within less than 3 min, all tested solutions were classified for Packing group I indicating corrosivity.

Eye irritation:

In an eye irritation study (Union Carbide, 1953; reliability score: 2) eye injury in rabbits was recorded in a 10-grade ordinal series based upon the degree of corneal necrosis that results from instillation of various volumes and concentrations of the chemical. The undiluted compound caused severe damage as did also 15% and 5% dilutions in propylene glycol. A 1% solution caused only slight injury.

Justification for classification or non-classification

The available experimental test data with the aqueous solution of ethylamine are reliable and suitable for classification purposes under Regulation 1272/2008. Based on the available data, the aqueous solution of the test substance is classified for skin corrosion cat. 1A and eye damage cat. 1, self-classification under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Regulation (EC) No. 2018/1480.