Registration Dossier
Registration Dossier
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EC number: 209-957-0 | CAS number: 598-94-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May - June 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,1-dimethylurea
- EC Number:
- 209-957-0
- EC Name:
- 1,1-dimethylurea
- Cas Number:
- 598-94-7
- Molecular formula:
- C3H8N2O
- IUPAC Name:
- 1,1-dimethylurea
- Reference substance name:
- Urea
- EC Number:
- 200-315-5
- EC Name:
- Urea
- Cas Number:
- 57-13-6
- Molecular formula:
- CH4N2O
- IUPAC Name:
- urea
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- dihydrogen oxide
- Test material form:
- solid: crystalline
Constituent 1
impurity 1
impurity 2
- Specific details on test material used for the study:
- - Analytical purity: at least 98 %
- Impurities (identity and concentrations): max. 2 % Urea, max. 0.2 % Isopropanol, max. 0.5 % diethyleneglycolmonoethylether
- Lot/batch No.: KG 03-13
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, 97633 Sulzfeld, Germany.
- Weight at study initiation: 2.0, 2.0 and 1.7 kg
- Housing: Individual caging in metal wire cages, Ehret GmbH, Emmendingen, type KK 016R, 79 cm x 59 cm bottom area, 38 cm height, with a wooden rest shelf, 15 cm x 59 cm. Exception: rest shelves are withdrawn during the exposure
- Diet (e.g. ad libitum): Altromin 2123 maintenance diet for rabbits, rich in crude fiber, ad libitu. Hay-briquettes (supplied by SSNIFF, 59494 Soest, Germany) was offered additionally as a dietry supplement.
- Water (e.g. ad libitum): Tap water from an automatic watering system, ad libitum.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Average of 19.5 °C (continuous control and recording)
- Humidity (%): Average of 67.5 % (continuous control and recording)
- Photoperiod (hrs dark / hrs light): Artificial light from 6 a.m. to 6 p.m.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Samples with approximately 0.5 g of the test substance (the weighed amount of the individual doses were 500, 498 and 500 mg) were moistened with 1.0 mL deionised water and were placed on cellulose patches.
- Duration of treatment / exposure:
- The duration of the exposure was 4 hours.
- Observation period:
- The skins of the animals were examined for local alterations one day before the administration of the test substance (after clipping of the hair) and immediately before the administration. The treated areas and the surrounding untreated skin (control area) of the animals were examined for erythema/eschar and oedema as well as for other local alterations approximately 1, 24, 48 and 72 hours after patch removal.
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: Test sites were median on the dorsal thoracal region
REMOVAL OF TEST SUBSTANCE
At the end of the exposure period the dressings, the taps with the patches and th collars were removed, residual test substance was wiped off with wet Kleenex-tissues, if necessary.
SCORING SYSTEM:
Erythema / Eschar formation:
0 No erythema
1 Very slight erythema (barely perceptible)
2 Well-defined erythema
3 Moderate to severe erythema
4 Severe erythema (beet redness) or eschar formation (injuries in depth)
Oedema formation
0 No oedema
1 Very slight oedema (barely perceptible)
2 Slight oedema (edges of areas well defined by definite raising)
3 Moderate oedema (raised approximately 1mm)
4 Severe oedema (raised more than 1 mm and extending beyond area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- Eschar
- Basis:
- animal #1
- Remarks:
- 11
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- Eschar
- Basis:
- animal #2
- Remarks:
- 12
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- Eschar
- Basis:
- animal #3
- Remarks:
- 13
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 11
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- 12
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- 13
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Other effects:
- No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occured.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occured. All exposed skin sites were normal at each examination term and 1,1 -Dimethylurea was classified as "non-irritant" to skin.
- Executive summary:
Possible irritation or corrosion by the test substance 1,1 -Dimethylurea was investigated by a single application to the intact skin of rabbits. The study was performed in accordance with method B.4 of Directive 92/69/EEC.
0.5 g 1,1 -Dimethylurea, moistened with deionised water, was applied via a patch to a site of 2.5 cm x 2.5 cm of the intact skin of each 3 rabbits and covered by a semi-occlusive dressing. The duration of the exposure was 4 hours.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occured. All exposed skin sites were normal at each examination term and 1,1 -Dimethylurea was classified as "non-irritant" to skin.
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