Registration Dossier
Registration Dossier
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EC number: 220-713-2 | CAS number: 2873-97-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-(1,1-dimethyl-3-oxobutyl)acrylamide
- EC Number:
- 220-713-2
- EC Name:
- N-(1,1-dimethyl-3-oxobutyl)acrylamide
- Cas Number:
- 2873-97-4
- Molecular formula:
- C9H15NO2
- IUPAC Name:
- N-(1,1-dimethyl-3-oxobutyl)acrylamide
- Reference substance name:
- Diacetone acrylamide
- IUPAC Name:
- Diacetone acrylamide
- Details on test material:
- Appearance: White powder. Batch No.: SSHD 044Conditions of storage: In the dark, may be used under light. Stability in aqueous solution: Stable.pH of a 1 % solution in deion. water: 6.49
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Species and strain: Rabbits, New Zealand White.Supplier: Charles River Deutschland GmbH, D-97633 Sulzfeld.Number and sex: 3 females.Body weights (at the start and at the termination of the study): 2.1-2.2 and 2.2-2.3 Hygiene: Optimal hygienic conditions.Room temperature: Average of 19.5 °C (continuous control and recording).Relative humidity: Average of 67.5 % (continuous control and recording).Light: Artificial light from 6 a.m. to 6 p.m.Cages: Individual caging in metal wire cages, Ehret GmbH, D-79312 Emmendingen, type KK 016R, 79 cm x 59 cm bottom area, 38 cm height.Feed: Altromin 2123 maintenance diet for rabbits, rich in crude fibre, ad libitum. Analysis of the feed for ingredients and contaminants is performed randomly by Altromin, D-32791 Lage, Germany.Hay-briquettes (supplied by SSNIFF, D-59494 Soest) are offered additionally as a dietary supplement.Water: Tap water from an automatic watering system, ad libitum.Environmental Enrichment: Aspen wood boards during acclimatisation and observation period. Exception: boards were withdrawn during the exposure.Acclimatisation: 5 daysIdentification: Individual labelling with felt-tipped pen on an ear pinna and cage labels.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- Samples with approximately 0.5 g of the test substance were moistened with 1.0 mL deionised water and were placed on cellulose patches in a size of about 2.5 cm x 2.5 cm and were applied to the test sites.
- Duration of treatment / exposure:
- 4 hours.
- Observation period:
- 72 hours. Examination at 1, 24, 48 and 72 hours after the patch removal.
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: each
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal: each
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Other effects:
- No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Any other information on results incl. tables
All areas treated with the test substance and all control areas were normal before the application and at each observation time.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Diacetone acrylamide is not irritating to skin.
- Executive summary:
The possible irritation or corrosion by the test substance following a single application to the intact skin of rabbits was determined applying the EU-method. Results:
Test sites, exposed for 4 hours (three animals):
- Erythema/Eschars: Not affected.
- Oedema: Not affected.
Diacetone acrylamide is not irritating to skin.
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