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 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: Denomination for the study: 08253 J6 002
- Physical state: white powder
- Analytical purity: 100%
- 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
- Other: Volumetric mass = 0.82 g/ml T= 20°C

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±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:

82 mg powdered acrylamide (equivalent to a volume of about 0.1ml)

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

24, 48, and 72 hours and at 7, 14, and 21 days post-application

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 and at 7, 14, and 21 days post-application to evaluate reversibility of the lesions,

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:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 24+48+72 hours

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 2

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24+48+72 hours

Score:

1.66

Max. score:

2

Reversibility:

fully reversible within: 14days

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24+48+72 hours

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 21 days

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24+48+72 hours

Score:

2

Max. score:

2.33

Reversibility:

fully reversible within: 14days

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 Days 7	Mean Day 14	Mean Day 21
Conjunctive: Chemosis Redness:	1.66	11	0	0
Iris Congestion	1	1	0.66	0
Corneal Degree of opacity:	2.11	2	0	0

The lesions observed at 72 hours showed a total reversibility in the 3 rabbits examined on day 21. It can be concluded from the results obtained under the experimental conditions employed that acrylamide is irritating to the eyes.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Acrylamide 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 21. It can be concluded from the results obtained under the experimental conditions employed that acrylamide is irritating to the eyes.