3-[(2-hydroxyethyl)amino]propionamide

Endpoint summary

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

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

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

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.

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

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

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

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

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available