N-(hydroxymethyl)acrylamide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented report of a guideline study conducted to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Acrylamide

EC Number:

201-173-7

EC Name:

Acrylamide

Cas Number:

79-06-1

Molecular formula:

C3H5NO

IUPAC Name:

Prop-2-enamide

Details on test material:

- Name of test material (as cited in study report): acrylamide:
- Molecular formula (if other than submission substance): C3H5NO
- Molecular weight (if other than submission substance): 71.08
- Smiles notation (if other than submission substance):O=C(\C=C)N
- InChl (if other than submission substance): 1/C3H5NO/c1-2-3(4)5/h2H,1H2,(H2,4,5)
- Denomination for the study: 08253 J6 001
- Physical state: colourless liquid
- Analytical purity: 50%
- Composition of test material, percentage of components: 100% pure
- Lot/batch No.: 616-003-00-0
- Expiration date of the lot/batch: not supplied by the Sponsor
- Storage condition of test material: at room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS: male rabbits (2.36-2.75kg)
- Source: E.S.D. (Romans, 01400 Châtillon-sur-Chalaronne, France),
- Age at study initiation: adult (about 3 months old),
- Weight at study initiation: 2.00 to 3.00 kg,
- Housing:individually housed In stainless steel cages (internal dimensions 500 x 600 x400 mm),
- Diet : about 150 g /animal/day of pelleted complete rabbit diet (Diet reference 112 C-IO _UAR. Villemoisson, 91360 Epinay-sur-Orge, France),
sterilised by irradiation and analysed for the absence of chemical and bacterial contaminants,
- Water (e.g. ad libitum): softened and filtered mains drinking water, ad libtum, analysed at least once a year for chemical contaminants and at
least twice a year for bacterial contaminants (Laboratoire de Chimie de l'environnement du Dépanement d'Ecologie Urbaine de la ville de Lyon),
- Acclimation period: at least 5 days between anima! arrival and start of treatment.

ENVIRONMENTAL CONDITIONS
- Temperature : 19 x 3°C
- Humidity : >=: 45 % R.H.
- Air changes : minimum of 12 air changes per hour,
- Photoperiod : 12 hours light (artificial)/l2 hours dark

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

24, 48, and 72 hours (7, 14, and 21 days post-application were scheduled but not necessary)

Number of animals or in vitro replicates:

3 males

Details on study design:

Examination for morbidity/mortality rate were performed twice daily
The animals were weighed on the day of dosing,
Reactions were scored at 1, 24, 48, and 72 hours (7, 14, and 21 days post-application to evaluate reversibility of the lesions were not required)

SCORING SYSTEM: From the scale published in the OECD Guideline 405 (J 987) and Directive EEC/92169
TOOL USED TO ASSESS SCORE: the presence of corneal erosion was demonstrated using fluorescein which was eliminated with lukewarm tap water.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24+48+72 hours

Score:

0.22

Max. score:

0.67

Reversibility:

fully reversible within: 48 hours

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24+48+72 hours

Score:

0.78

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 24+48+72 hours

Score:

0.89

Max. score:

1.33

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24+48+72 hours

Score:

0.56

Max. score:

1

Reversibility:

fully reversible within: 7 days

Other effects:

There were no mortalities. there was no indication of whether or not there were any clinical signs of toxicity.

Any other information on results incl. tables

	Mean 24 +48 +72 hours	Mean 7 Days	Mean 14 Days	Mean 21 Days
Corneal Degree of Opacity	0.22	0	not required	not required
Iris Congestion	0.78	0	not required	not required
Conjuctive Redness	0.89	0	not required	not required
Conjunctive Chemosis	0.56	0	not required	not required

The lesions observed at 72 hours showed a total reversibility in the 3 rabbits examined on day 7.

It can be concluded from the results obtained under the experimental conditions employed that the test substance is not irritating to the eyes.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Acrylamide in solution at 50% concentration was tested in the rabbit for eye irritation according to OECD Test Guideline 405 under GLP conditions. The lesions observed at 72 hours showed a total reversibility in the 3 rabbits examined on day 7. It can be concluded from the results obtained under the experimental conditions employed that acrylamide in solution at 50% is not irritating to the eyes.