3-[(2-hydroxyethyl)amino]propionamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993-03-30 to 1993-04-02

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study is an OECD 401 study under GLP and well documented

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

ACMEO

IUPAC Name:

ACMEO

Constituent 2

Reference substance name:

3-[(2-hydroxyethyl)amino]propionamide

EC Number:

248-211-9

EC Name:

3-[(2-hydroxyethyl)amino]propionamide

Cas Number:

27076-30-8

Molecular formula:

C5H12N2O2

IUPAC Name:

N~3~-(2-hydroxyethyl)-beta-alaninamide

Test material form:

other: colourless slightly viscous liquid

Details on test material:

- Name of test material (as cited in study report): ACMEO
- Physical state: colourless slightly viscous liquid
- Analytical purity: n.a.
- Lot/batch No.: 3S1005
- Storage condition of test material: +4°C

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: rabbjts were suppl ied by David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: n.a.
- Weight at study initiation: 2.50 - 2.86 kg
- Housing: animals were housed individual in suspended metal cages
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 21°C
- Humidity (%): 37 - 46 %
- Air changes (per hr): 15/ hr
- Photoperiod (hrs dark / hrs light): 12 hours dark/112 hours light

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 mL of undiluted test substance

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm gauze patch
- % coverage: n.a.
- Type of wrap if used: To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any residual test material removed by gentle swabbing with cotton wool soaked in diethyl ether.
- Time after start of exposure: 4 hours after application the corset and patches were removed from each animal.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Remarks:

male

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

male

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Results 3

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

female

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

male

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Results 5

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

female

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible within: 72 hours

Results 6

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

male

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

Very slight erythema was noted at all treated skin sites one hour after patch removal and at two treated skin sites at the 24- and 48-hour observations.
Very slight oedema was noted at one treated skin site at the 24 hour observation. All treated skin sites appeared normal at the 72-hour observation.
No corrosive effects were noted.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Based on the results of this OECD 404 study in rabbits the test substance is not irritant to the skin.

Executive summary:

ACMEO was tested for primary skin irritation according to OECD test guideline 404 in New Zealand White rabbits. The test substance was applied undiluted under semiocclusive conditions to the intact clipped skin for 4 hours. Thereafter, the wrapping was removed and the residual test material was removed by gently swabbing with cotton wool soaked in diethyether. Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to Draize. Very slight erythema was noted at all treated skin sites one hour after patch removal and at two treated skin sites at the 24- and 48-hour observations. Very slight oedema was noted at one treated skin site at the 24 hour observation. All treated skin sites appeared normal at the 72-hour observation. No corrosive effects were noted.