2-(2-aminoethylamino)ethanol

Endpoint summary

Description of key information

When tested for skin irritation in the rabbit according to or comparable to OECD guideline 404 AEEA was corrosive after an exposure period of 1 or 4 hours, but not after a 3 min exposure period.  In an eye irritation study comparable to OECD guideline 405 AEEA caused moderate irritating effects in rabbits which were not reversible within 8 days.

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:

other: Comparable to guideline study. Irreversible skin damage was observed following 4-hr exposure in 2/2 animals, therefore the short observation period (8 days) is in line with the provisions of OECD TG 404.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

no 72 h reading

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: M. GAUCKLER, 6050 Offenbach, Germany
- Weight at study initiation: mean bw was 3.0 kg
- Diet: Ssniff K standard diet, Intermast GmbH Soest, Germany, ad libitum:
- Water: tap water ad libitum

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied : 0.5 mL of the neat test substance was applied to the intact dorsal skin, clipped 24 h before treatment
- Concentration: undiluted

Duration of treatment / exposure:

1 hour (4 animals), 4 hours (2 animals)

Observation period:

8 days

Number of animals:

6 male and female rabbits

Details on study design:

TEST SITE
- Area of exposure: 4 cm²
- coverage: 100 %
- Type of wrap if used: rubberbacked linen cloth


REMOVAL OF TEST SUBSTANCE
- Washing: At the end of the exposure period excess AEEA was removed and the skin was rinsed with lutrol or a mixiture of water/lutrol (1:1) and dried  with pulp
- Skin reactions were examined and scored immediately after patch removal, and 1, 2, and 8 days thereafter


SCORING SYSTEM: Draize

Irritation parameter:

erythema score

Remarks:

(4 h exposure)

Basis:

animal #1

Time point:

other: 4, 24, 48 hours

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks:

necrosis developed after 4 hours and was not reversible within 8 days

Remarks on result:

other: 4 h exposure

Irritation parameter:

erythema score

Remarks:

(4 h exposure)

Basis:

animal #2

Time point:

other: 4, 24, 48 hours

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks:

necrosis developed after 8 days

Remarks on result:

other: 4 h exposure

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 4, 24, 48 hours

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks:

necrosis develpoed in both animals

Remarks on result:

other: 4 h exposure

Irritation parameter:

edema score

Remarks:

(4 h exposure)

Basis:

animal #1

Time point:

other: 4, 24, 48 hours

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: 4 h exposure

Irritation parameter:

edema score

Remarks:

(4 h exposure)

Basis:

animal #2

Time point:

other: 4, 24, 48 hours

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: 4 h exposure

Irritation parameter:

edema score

Remarks:

(4 h exposure)

Basis:

mean

Time point:

other: 4, 24, 48 hours

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: 4 h exposure

Irritation parameter:

erythema score

Remarks:

(1 h exposure)

Basis:

animal #1

Time point:

other: 1, 24, 48 hours

Score:

3.67

Max. score:

4

Reversibility:

not reversible

Remarks:

necrosis developed within 1 day

Remarks on result:

other: 1 h exposure

Irritation parameter:

erythema score

Remarks:

(1 h exposure)

Basis:

animal #2

Time point:

other: 1, 24, 48 hours

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: 1 h exposure

Irritation parameter:

erythema score

Remarks:

(1 h exposure)

Basis:

animal #3

Time point:

other: 1, 24, 48 hours

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 8 days, scales developed within 8 days

Remarks on result:

other: 1 h exposure

Irritation parameter:

erythema score

Remarks:

(1 h exposure)

Basis:

animal #4

Time point:

other: 1, 24, 48 hours

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 1 day

Remarks on result:

other: 1 h exposure

Irritation parameter:

erythema score

Remarks:

(1 h exposure)

Basis:

mean

Time point:

other: 1, 24, 48 hours

Score:

2.09

Max. score:

4

Remarks on result:

other: 1 h exposure

Irritation parameter:

edema score

Remarks:

(1 h exposure)

Basis:

animal #1

Time point:

other: 1, 24, 48 hours

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: 1 h exposure

Irritation parameter:

edema score

Remarks:

(1 h exposure)

Basis:

animal #2

Time point:

other: 1, 24, 48 hours

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: 1 h exposure

Irritation parameter:

edema score

Remarks:

(1 h exposure)

Basis:

animal #3

Time point:

other: 1, 24, 48 hours

Score:

1.33

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: 1 h exposure

Irritation parameter:

edema score

Remarks:

(1 h exposure)

Basis:

animal #4

Time point:

other: 1, 24, 48 hours

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 1 day

Remarks on result:

other: 1 h exposure

Irritation parameter:

edema score

Remarks:

(1 h exposure)

Basis:

mean

Time point:

other: 1, 24, 48 hours

Score:

1.33

Max. score:

4

Remarks on result:

other: 1 h exposure

Necroses (full thickness) were confirmed by pathological examination of the skin after terminal sacrifice.
No signs of systemic toxicity were noted following either treatment.

Interpretation of results:

corrosive

Remarks:

Migrated information

Executive summary:

In a dermal irritation study (BASF AG, Department of Toxicology, 1979) six Vienna White rabbits were dermally exposed to undiluted AEEA. The test site (intact dorsal skin) was covered with an occlusive dressing for 1 or 4 hours. Rabbits then were observed for 8 days. Irritations regarding erythema, edema and necrosis were scored and converted into the presently used numerical grading system according to the OECD system. AEEA exhibited a corrosive potential in this study, since the development of necrosis, which were not reversible within 8 days, were noted in both the 1-hour exposure group (1/4 animals) and the 4-hours exposure group (1/2 animals).

 

Mean scores 1-hour exposure (4 animals):

Erythema:        2.09 of max. 4

Edema:            1.33 of max. 4

 

Mean scores 4-hour exposure (2 animals):

Erythema:        3.00 of max. 4

Edema:           2.00 of max. 4

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: Comparable to guideline study with acceptable restriction. Restriction: TS volume 0.05 mL instead of 0.1 mL

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

TS volume 0.05 mL instead of 0.1 mL, no 72 h reading

GLP compliance:

no

Species:

rabbit

Strain:

not specified

Vehicle:

physiological saline

Controls:

yes, concurrent vehicle

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.05 mL
- Concentration: undiluted

Duration of treatment / exposure:

- single treatment
- the eyes were not washed out after 24 h

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

1 rabbit

Details on study design:

Scoring system: Draize

Tool used to assess score: hand-slit lamp / biomicroscope / fluorescein

Irritation parameter:

other: erythema score

Basis:

animal #1

Time point:

other: 1, 24 hours

Score:

2

Max. score:

3

Reversibility:

not reversible

Remarks on result:

other: bleeding

Irritation parameter:

other: edema score

Basis:

animal #1

Time point:

other: 1, 24 hours

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: bleeding

Irritation parameter:

other: opacity score

Basis:

animal #1

Time point:

other: 1, 24 hours

Score:

2

Max. score:

3

Reversibility:

not reversible

Remarks on result:

other: formation of pus and staphyloma after 8 days

Interpretation of results:

corrosive

Remarks:

Migrated information

Executive summary:

In a primary eye irritation study (BASF XX / 174) a rabbit was exposed to 0.05 mL of AEEA (99 -100 %). The animal then was observed for 8 days. Irritation was scored after 1 and 24 hours by the method of Draize. The substance AEEA revealed moderate eye irritating effects in rabbits (edema score 3.0, erythema score 2.0, opacity score 2.0). Effects were not reversible within 8 days. The results in this study are in line with the corrosive properties of AEEA on the skin.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin:

In a dermal irritation study (Tuffnell, 1990) three New Zealand White rabbits were dermally exposed to 0.5 mL of undiluted AEEA for 4 hours with a semi-occlusive dressing. In this initial study the test material produced corrosive effects to the skin following the 4-hour exposure period. Therefore the effects of the test material following a 3-minute exposure period were assessed in an additional test with another 3 animals. Rabbits were observed for 14 and 7 days, respectively. Irritations regarding erythema, edema and necrosis were scored using the grading system according to the Daraize scheme. The development of necrosis, leading to scar formation after 14 days, and well defined erythema as well as slight to moderate edema were noted in the 4-hour exposure group. Only very slight erythema and edema as well as desquamation were seen in the 3-min exposure group, so that AEEA showed a moderate corrosive potential in this study, concerning the results of the 4-hours exposure group.

 

Mean scores 3 min-hour exposure (3 animals; 24, 48, 72 h reading):

Erythema:        1.30 of max. 4

Edema:            0.67 of max. 4

 

Mean scores 4-hour exposure (3 animals; 24, 48, 72 h reading):

Erythema:        2.57 of max. 4

Edema:           1.90 -2.80 of max. 4

In a dermal irritation study (BASF AG, Department of Toxicology, 1979) six Vienna White rabbits were dermally exposed to 0.5 mL of undiluted AEEA. The test site (intact dorsal skin) was covered with an occlusive dressing for 1 or 4 hours. Rabbits then were observed for 8 days. Irritations regarding erythema, edema and necrosis were scored and converted into the presently used numerical grading system according to the OECD system. AEEA exhibited a corrosive potential in this study, since the development of full thickness necrosis were noted in both the 1-hour exposure group (1/4 animals) and the 4-hours exposure group (1/2 animals).

 

Mean scores 1-hour exposure (4 animals; 1, 24, 48 h reading):

Erythema:        2.09 of max. 4

Edema:            1.33 of max. 4

 

Mean scores 4-hour exposure (2 animals; 4, 24, 48 h reading):

Erythema:        3.00 of max. 4

Edema:            2.00 of max. 4

Eye:

In a primary eye irritation study (BASF AG, Department of Toxicology, 1970) a rabbit was exposed to 0.05 mL of AEEA (99 -100 %). The animal then was observed for 8 days. Irritation was scored by the method of Draize after 1 and 24 hours. The substance AEEA revealed moderate eye irritating effects in rabbits (edema score 3.0, erythema score 2.0, opacity score 2.0). Effects were not reversible within 8 days. The results in this study are in line with the corrosive properties of AEEA on the skin.

Justification for selection of skin irritation / corrosion endpoint:
The Key study (BASF AG, 1979) was selected.

Justification for selection of eye irritation endpoint:
The Key study (BASF AG, 1970) was selected.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: moderately irritating

Justification for classification or non-classification

Based on the results of the skin and eye irritation key toxicity studies, AEEA is subjected to classification to R34 (causes burns) according to Directive 67/548/EEC and skin corrosive Cat 1 B / H314 (causes severe skin burns and eye damage) according to Regulation 1272/2008/EC.