Acrylamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

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: considered as 100 % for the study
- Composition of test material, percentage of components: 100 %
- 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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- 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 (iniernal dimensions 500 x 600 x 400 mm).
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days, between animal arrival and start of treatment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19±3
- Humidity : ≥45 % R.H.
- Air changes : minimum 12 air changes per hour,
- Photoperiod :12 hours light (artificial)!l2 hours dark.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied : 0.5 g per animal of the test artïcle prepared as a paste with 0.086 g of water for injection.
- Concentration : 100%

VEHICLE:
- water for injection Laboratoire Biosedra, Louviers, France
- Lot/batch no. (if required): LD 3 I 19

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours after the removal of the bandage

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: direct application to the animal's skin, to an area about 6 cm2
- Type of wrap if used: Codex hydrophilic eight layer gauze pad.


REMOVAL OF TEST SUBSTANCE
- Washing : excess test article which has not penetrated was wiped away with a gauze pad moistened with water
The reading was carried out 1 hour later.
- Time after start of exposure: 4 hours


SCORING SYSTEM:
According to the scale published in the O.E.C.D. Guideline (n° 404 - 1992) and the O.J.E.C. (n° L 383A of 29 December 1992):

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24+48+72 hours

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24+48+72 hours

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritant / corrosive response data:

No erythema or edema were observed

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Acrylamide was tested in the rabbit for skin irritation according to OECD Test Guideline 404 under GLP conditions. Neither erythema nor oedema was observed at any time. It can be concluded from the results obtained under the experimental conditions employed that acrylamide is not irritating to skin.