2-(2-aminoethylamino)ethanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-(2-aminoethylamino)ethanol

EC Number:

203-867-5

EC Name:

2-(2-aminoethylamino)ethanol

Cas Number:

111-41-1

Molecular formula:

C4H12N2O

IUPAC Name:

2-[(2-aminoethyl)amino]ethan-1-ol

Test material form:

not specified

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: M. GAUKLER, 6050 Offenbach
- Age at study initiation: not indicated
- Weight at study initiation: 4- hour exposure: ca 3.1 kg; 1 hour exposure 3.0 kg.
- Housing: not indicated
- Diet: Ssniff K, INTERMAST GMBH, Soest, ad libitum (no food during exposure)
- Water: Ad libitum
- Acclimation period: not indicated

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied : 0.5 mL test item

Duration of treatment / exposure:

4 hours and 1 hour treatment period

Observation period:

8 days

Number of animals:

4 Hours test: 2 males
1 Hour test: 2 males and 2 females

Details on study design:

TEST SITE
- Area of exposure: 2 * 2 cm on the backsite of the rabbit.
- % coverage: covered with a linnen cloth, fixated with an adhesive bandage (semi-occlusive)

REMOVAL OF TEST SUBSTANCE
- Washing: Washing with Lutrol/water-mix (1:1)
- Time after start of exposure: 4 hours or 1 hour.

OBSERVATION TIME POINTS
Observations were made directly after the removal of the test item, and on one, two and 8 days after removal of the test item.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

1 Hour exposure

Basis:

animal #1

Time point:

24 h

Score:

4

Max. score:

4

Remarks on result:

other:

Remarks:

Slight necrosis

Results 2

Irritation parameter:

erythema score

Remarks:

1 Hour exposure

Basis:

animal #1

Time point:

48 h

Score:

4

Max. score:

4

Remarks on result:

other: Necrosis and dry skin

Results 3

Irritation parameter:

erythema score

Remarks:

1 hour exposure

Basis:

animal #1

Time point:

other: 8d

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Leathery Necrosis

Results 4

Irritation parameter:

erythema score

Remarks:

1 Hour exposure

Basis:

animal #2

Time point:

24/48 h

Score:

2

Max. score:

4

Results 5

Irritation parameter:

erythema score

Remarks:

1 Hour exposure

Basis:

animal #2

Time point:

other: 8d

Score:

0

Reversibility:

fully reversible

Results 6

Irritation parameter:

erythema score

Remarks:

1 Hour exposure

Basis:

animal #3

Time point:

24/48 h

Score:

2

Max. score:

4

Results 7

Irritation parameter:

erythema score

Remarks:

1 Hour exposure

Basis:

animal #3

Time point:

other: 8d

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 8d

Remarks on result:

other: peeling of the skin

Results 8

Irritation parameter:

erythema score

Remarks:

1 Hour exposure

Basis:

animal #4

Time point:

other: 24h/48h/8d

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24h

Results 9

Irritation parameter:

edema score

Remarks:

1 Hour exposure

Basis:

animal #1

Time point:

24/48 h

Score:

1

Max. score:

4

Results 10

Irritation parameter:

edema score

Remarks:

1 Hour exposure

Basis:

animal #1

Time point:

other: 8d

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 8d

Results 11

Irritation parameter:

edema score

Remarks:

1 Hour exposure

Basis:

animal #2

Time point:

24/48 h

Score:

1

Max. score:

4

Results 12

Irritation parameter:

edema score

Remarks:

1 Hour exposure

Basis:

animal #2

Time point:

other: 8d

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 8d

Results 13

Irritation parameter:

edema score

Remarks:

1 Hour exposure

Basis:

animal #3

Time point:

other: 24h/48h/8d

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 8d

Results 14

Irritation parameter:

edema score

Remarks:

1 Hour exposure

Basis:

animal #4

Time point:

other: 24h/48h8d

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24h

Irritant / corrosive response data:

Irritation paratmeters directly after 1 hour exposure:
- Erytherma; one animal showed strong erythema (score 3, animal #1) and three animals showed light erythema (score 2).
- Edema: All animals showed light edema (score 2).
- Corrosive response; One aminal showed necrosis, not reversible within 8 days. One animal showed peeling of the skin 8d after exposure.

Results of the 4 Hour exposure: See attachtted table in "attached documents"

Applicant's summary and conclusion

Interpretation of results:

Category 1 (corrosive) based on GHS criteria

Conclusions:

Based on these results aminoethylethanolamin is considered to be corrosive.

Executive summary:

A skin irrtitation test was performed with Aminoäthyläthanolamin-S. The test item was applied undiluted (0.5 mL) directly on top of the shaved skin tissue for 1 hour(4 animals) or 4 hours (two animals). Directly after the exposure period and 1, 2 and 8 days after the exposure period the skin was examined for irritating and corrosive effects.

Severe necrosis was observed after exposure to Aminoäthyläthanolamin-S for 1 hour and 4hours.

Based on these results the test chemical is considered to be corrosive Catogory 1 based on GHS citeria.