Registration Dossier
Registration Dossier
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EC number: 428-710-1 | CAS number: 207574-76-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 428-710-1
- EC Name:
- -
- Cas Number:
- 207574-76-3
- Molecular formula:
- C46H68N6O6 / C48H72N6O6 / C50H76N6O6 / C52H80N6O6 / C54H84N6O6
- IUPAC Name:
- Condensation products of m-phenylenebis(methylamine) with condensation products of 4-methyl-m-phenylene diisocyanate with alcohols, C10-14 (even numbered)
- Details on test material:
- - Physical state: powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: 3.0 kg (average)
- Housing: single cage
- Diet (e.g. ad libitum): Altromin, Lage, ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C +/- 2°C
- Humidity (%): 50-60%
- Photoperiod (hrs dark / hrs light): 12 hours
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 500 mg of the compound were applied and covered with gauze patches in a size of about 2.5 cm x 2.5 cm.
This was wettened with 10 mL warmed water. - Duration of treatment / exposure:
- 4 h
- Observation period:
- The treated areas of the animals were examined 1 hour after patch removal. Thereafter, the readings have been repeated every 24 hours. The final control of localization has been carried out after 7 days.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: gauze patches were fixed with the help of adhesive plaster
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance was touched away with a wet towel
- Time after start of exposure: 1 h
SCORING SYSTEM:
1. Erythema and formation of scabs:
- No erythema: 0
- slight erythema (scarcely visible): 1
- Moderate to significant erythema: 3
- Severe erythema (red purple) with formation of slight scabs (deep lesions): 4
2. Formation of oedema:
- No oedema: 0
- Very slight oedema (scarcely visible): 1
- Slight oedema (well defined outlines, swelling apparent): 2
- Moderate oedema (thickness about 1 mm): 3
- Severe oedema (thickness more than 1 mm and area larger than of the square): 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no erythema observed
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no erythema observed
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no erythema observed
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema observed
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema observed
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema observed
- Irritant / corrosive response data:
- No deviations from the normal findings have been observed during the whole experiment on any animal on the shave skin localizations.
- Other effects:
- No test-substance related findings were observed during the weighting of the animals after 7 days.
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating according to Regulation (EC) 1272/2008
- Conclusions:
- As no skin reaction was induced over a period of 7 days, the test item is considered as not skin irritating. Based on these results and according to the EC criteria for classification and labelling, Regulation (EC) No. 1272/2008, the test item does not have to be classified and has no obligatory labelling requirement for skin irritation.
- Executive summary:
As no skin reaction was induced over a period of 7 days in a GLP study acc. to OECD guideline no. 404, test item is considered as not skin irritating.
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