2-Propenamide, N-(2-hydroxyethyl)-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 June 2006 to 28 July 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Eye Irritation (2-1-5), 12 Nohsan No. 8147, Agricultural Productions Bureau, 24 November 2000.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

N-(2-hydroxyethyl)prop-2-enamide

EC Number:

700-169-7

Cas Number:

7646-67-5

Molecular formula:

C5H9NO2

IUPAC Name:

N-(2-hydroxyethyl)prop-2-enamide

Specific details on test material used for the study:

Lot number: 050804
Purity: >99%

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: 21 weeks
- Weight at study initiation: 3.38 to 3.55 kg
- Housing: The rabbits were housed individually in plastic cages with perforated floors
- Diet : Each rabbit was offered 125 g of a standard laboratory rabbit diet (Rabbit GD Diet Pellets supplied by Highgate Farm) per day
- Water: ad libitum
- Acclimation period: All rabbits were acclimatised to the experimental environment for a period of approximately nine weeks prior to the start of the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 20°C
- Humidity (%): 40 to 70%
- Air changes (per hr): Unknown
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Each rabbit was administered with a single ocular dose of 0.1 ml of the test substance.

VEHICLE
- Amount(s) applied (volume or weight with unit): None

Duration of treatment / exposure:

The dose was instilled into the right eye by pulling the lower eyelid away from the eye ball to form a cup into which the test substance was dropped. The eyelids were then gently held together for one second before releasing; the left eye remained untreated.

Observation period (in vivo):

Observations were taken at 1 hour and 24, 48 and 72 hours and at 8, 15 and 22 days.

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure:

SCORING SYSTEM: Kay and Calandra

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

1.7

Max. score:

2

Reversibility:

not reversible

Remarks:

one animal reversed at day 8, two animals not reversed till day 22

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 24 hours

Irritant / corrosive response data:

Injection of the conjunctival blood vessels, a crimson-red or a beefy-red appearance was apparent in all cases throught the first week of observations; injection of the conjunctival blood vessels was stilll apparent at the end of the observation period in two animals. Moderate discharge was present in all animals with slight chemosis one hour after instillation.
Instillation of the test material gave rise to a moderate initial pain response in the sentinel animal, local ocular anaesthesia was employed for the subsequent animals. An apparent moderate initial pain response was also noted for these animals, however, since anaesthesia had been administered prior to test substance instillation, it is considered that these reactions were responses toward the physical instillation of dose rather than to a pain stimuli.

Other effects:

There was no sign of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

The substance cause irreversible reactions in conjunctiva of two animals.

Executive summary:

The study was performed to assess the eye irritation potential of HEAA to the rabbit, according to OECD Guideline 405, under GLP.

The substance cause irreversible reactions in conjunctiva of two animals.