2-ethylaminoethanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1 February 1978 to 14 March 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-guideline study , non-GLP

Data source

Reference

Reference Type:

study report

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:

not specified

Principles of method if other than guideline:

BASF test methods used were similar to those subsequently outlined in OECD acute testing guidelines for determination of skin irritation.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

ethylethanolamine

IUPAC Name:

ethylethanolamine

Constituent 2

Reference substance name:

2-ethylaminoethanol

EC Number:

203-797-5

EC Name:

2-ethylaminoethanol

Cas Number:

110-73-6

Molecular formula:

C4H11NO

IUPAC Name:

2-ethylaminoethanol

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report):ethylethanolamine (Athylathanolamin)
- Physical state: liquid

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no information
- Age at study initiation:no information
- Weight at study initiation: no information
- Fasting period before study: not applicable


IN-LIFE DATES: From/To: no information

Test system

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

No data

Duration of treatment / exposure:

3 min, 1 h, 4 h

Observation period:

3min, 1 d, 2 d, 8d

Number of animals:

2 for the 4 h treatment
4 for the 1 h treatment
2 for the 3 min treatment

Details on study design:

Four rabbits were assessed for primary skin irritation. Assessment of erythema and oedematous responses was completed one hour after the 3 min, one hour or fur hour exposures and again on days 1, 2 and 8. The current test guidelines require an assessment 24, 48 and 72 hours after dosing but these data are not available to derive a mean score for classification. However the severity of the dermal response over tehe study period is sufficient to derive a classification for ethylethanolamine.

TEST SITE
- Area of exposure: Back (2.5 x 2.5 cm)

SCORING SYSTEM: Draize scoring system. Results originally reported according to BASF scoring system and transformed to scores according to OECD guideline 404.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24, 48 hr

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: 4 hr treatment

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24, 48 hr

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: 4 hr treatment

Results 3

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24, 48 hr

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: 4 hr treatment

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24, 48 hr

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: 4 hr treatment

Results 5

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 hr

Score:

3.25

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: 1 hr treatment

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 hr

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: 1 hr treatment

Results 7

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 hr

Score:

0

Max. score:

4

Remarks on result:

other: 3 minute treatment

Results 8

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 hr

Score:

0

Max. score:

4

Remarks on result:

other: 3 minute treatment

Irritant / corrosive response data:

Well defined to moderate erythema (grade 2 or higher) was evident for all four rabbits after removal of the dressing and while well defined erythema persisted in one rabbit to day 8, the reactions in the other three became progressively more marked and severe erythema was recorded on days 1, 2 and 8 together with other dermal reactions which are not defined in the study report. Moderate oedema formation present one hour after dosing showed some amelioration on days 1 and 2 but some degree of oedema persisted in two animals to day 8.

Other effects:

Necrosis was observed after 1 and 4 h treatment.

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the available data, the test substance showed corrosive effects after application to the skin of rabbits.

Executive summary:

Application to rabbit skin for periods of 3 minutes, one hour or four hours resulted in no reactions (3 min exposure) or erythema, oedema and necrosis (1 and 4 hour exposures). The persistent reactions and irreversible damage caused resulted in classification as a skin corrosive (Cat 1B, according to Classification, Labelling and Packaging Regulation 1272/2008)