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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
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 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
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 (e.g. ad libitum): about 150 g/anil1al/day of pelleted complete rabbii diet (Diel reference 1 12 C-IO _UAR, Villemoisson, 91360 Epinay-sur-Orge, France), sterilised by irradiation and
analysed for the absence of chemical and bacierial contaminants.
- Water (e.g. ad libitum):softened and filtered mains drinking water, ad libitum analysed at least once a year for chemical contaminants and at least twice a year for bacterial contaminants
(Laboratoire de Chimie de I'environnement du Département d'Ecologie Urbaine de la ville de Lyon).
- Acclimation period: at least 5 day, 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24+48+72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
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
Other effects:
No mortalities. There was no indication of whether or not there were any clinical signs of toxicity.

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.