2-(2-aminoethoxy)ethanol

Endpoint summary

Description of key information

Irritation:
- skin: corrosive
- eye: corrosive

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Principles of method if other than guideline:

BASF-Test, see details in remarks on results.

GLP compliance:

no

Specific details on test material used for the study:

- Name of test material (as cited in study report): Aminodiglykol, 2-(2-Hydroxyaethoxy-)aethylamin
- Physical state: liquid
- Analytical purity: > 99 %

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.46 and 2.88 kg

Type of coverage:

occlusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Duration of treatment / exposure:

1 min, 5 min, 15 min or 20 h.

Observation period:

8 days

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: 2.5x2.5 cm


REMOVAL OF TEST SUBSTANCE
- Washing (if done): concentrated Lutrol and 50% Lutrol
- Time after start of exposure: 1 min, 5 min and 15 min

Irritation parameter:

erythema score

Remarks:

, 1 min exposure

Basis:

mean

Time point:

other: 24 h - 48 h - 72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

erythema score

Remarks:

, 5 min

Basis:

mean

Time point:

other: 24 h - 48 h - 72 h

Score:

0.6

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: scale formation

Irritation parameter:

erythema score

Remarks:

, 15 min exposure

Basis:

mean

Time point:

other: 24 h - 48 h - 72 h

Score:

1.5

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: necrosis

Irritation parameter:

erythema score

Remarks:

20 h exposure

Basis:

mean

Time point:

other: 24 h - 48 h - 72 h

Score:

2.5

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: full thickness necrosis

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 h - 48 h - 72 h

Score:

0

Max. score:

4

Reversibility:

other: no symptoms

Mean erythema score after 24, 48 and 72 h (animal1/2)

Exposure time	24 h	48 h	72 h	mean
1 min	1/1	0/0	0/0	0.3/0.3
5 min	1/1	0/1	0/1	0.3/1
15 min	1/3	0/3	0/2	0.3/2.7
20 h	2/3	2/3	3/3	2/3

Mean edema score after 24, 48 and 72 h (animal1/2)

Exposure time	24 h	48 h	72 h	mean
1 min	0/0	0/0	0/0	0/0
5 min	0/0	0/0	0/0	0/0
15 min	0/0	0/0	0/0	0/0
20 h	0/0	0/0	0/0	0/0

The application of the test substance caused slight erythema after a 1 and 5 min exposure and moderate to severe erythema after a 15 min or 20 h exposure. After 15 min of exposure one animal developed necrosis 72 post exposure. 20 h of exposure led to anaemic necrosis which developed in 1 animal to hart necrosis at the end of the observation period. The appearing necrosis is considered as a full thickness necrosis.

The original BASF grading was converted into the numerical grading according the OECD Draize system.

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Conclusions:

Corrosive

Executive summary:

The application of the test substance caused slight erythema after a 1 and 5 min exposure and moderate to severe erythema after a 15 min or 20 h exposure. After 15 min of exposure one animal developed necrosis 72 h post exposure. 20 h of exposure led to anaemic necrosis which developed in 1 animal to hart necrosis at the end of the observation period.

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Principles of method if other than guideline:

BASF-Test, see details in remarks on results.

GLP compliance:

no

Specific details on test material used for the study:

- Name of test material (as cited in study report): Aminodiglykol, 2-(2-Hydroxyaethoxy-)aethylamin
- Physical state: liquid
- Analytical purity: > 99 %

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.87 and 2.92 kg

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent negative control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl

Duration of treatment / exposure:

8 days (single application)

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 h - 48 h - 72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 h - 48 h - 72 h

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 h - 48 h -72 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 h - 48 h - 72 h

Score:

1.5

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Findings animal1/2:

Time

Opacity

Iritis

Erythema

Chemosis

1h

1/3

0/0

2/2

2/2

24h

1/3

0/0

2/2

2/2

48h

1/1

1/2

2/2

1/1

72h

3/3

1/2

2/2

1/2

8d

3/3

0/2

0/2

0/2

Mean values over 24h, 48h and 72h:

Animal1: Opacity: 1.7; Iritis: 0.7; Erythema: 2; Chemosis: 1.3;

Animal2: Opacity: 2.3; Iritis: 1.3; Erythema: 2; Chemosis: 1.7;

The application of the test substance caused moderate to severe corneal opacity, irritis, moderate erythema and slight to moderate chemosis.

At the end of the observation period after 8 days staphyloma and severe corneal opacity were noted. Severe corneal opacity, is considered to be an irreversible effect to ophthalmic tissue.

The original BASF grading was converted into the numerical grading according to the OECD Draize system.

Interpretation of results:

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

Conclusions:

Irreversible effects on the eyes / serious damage to eyes

Executive summary:

In a primary eye irritation study in rabbits, 50 µL of the test substance caused moderate to severe irreversible corneal opacity, irritis, moderate erythema and slight to moderate chemosis. At the end of the observation period after 8 days staphyloma and severe corneal opacity were noted.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

Skin irritation:

The application of the test substance caused slight erythema after a 1 and 5 min exposure and moderate to severe erythema after a 15 min or 20 h exposure. After 15 min of exposure one animal developed necrosis 72 post exposure. 20 h of exposure led to anaemic necrosis which developed in 1 animal to hart necrosis at the end of the observation period (BASF AG 1969). In two further skin irritation studies which are available as secondary sources, after a 1-3 min exposure no signs of irritation were observed. Slight to severe erythema were observed after a 60 min and 4 hour exposure period. Moderate oedema was also observed after 4 hours. (Huntsman et al. 1984). In a 4 h and 24 h exposure study severe erythema, oedema and necrosis, sloughing, fissuring were observed at the application sites (Huntsman et al. 1992).

 

Eye irritation:

In a primary eye irritation study in rabbits, 50 µL of the test substance caused moderate to severe irreversible corneal opacity, irritis, moderate erythema and slight to moderate chemosis. At the end of the observation period after 8 days staphyloma and severe corneal opacity were noted (BASF AG 1969). A further publication confirmed these severe corrosive effects (Smyth et al. 1951).

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. The substance shows a skin and eye irritation potential and needs to be classified as corrosiv under Regulation (EC) No 1272/2008.