Registration Dossier
Registration Dossier
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EC number: 617-879-7 | CAS number: 865536-03-4
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:
- 2 008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- bis(11-methyldodecyl) ((((1,3-phenylenebis(methylene)bis(azanediyl))bis(carbonyl) bis(azanediyl))bis(4-methyl-3,1-phenylene) dicarbamate
- Cas Number:
- 865536-03-4
- Molecular formula:
- C52H80N6O6
- IUPAC Name:
- bis(11-methyldodecyl) ((((1,3-phenylenebis(methylene)bis(azanediyl))bis(carbonyl) bis(azanediyl))bis(4-methyl-3,1-phenylene) dicarbamate
- Reference substance name:
- bis(11-methyldodecyl)(4-methyl-1,3-phenylene)dicarbamate
- Molecular formula:
- C35H62N2O4
- IUPAC Name:
- bis(11-methyldodecyl)(4-methyl-1,3-phenylene)dicarbamate
- Reference substance name:
- 11-methyldodecyl (3-(3-(3-(aminomethyl)benzyl)ureido)-4-methylphenyl)carbamate
- Molecular formula:
- C30H46N4O3
- IUPAC Name:
- 11-methyldodecyl (3-(3-(3-(aminomethyl)benzyl)ureido)-4-methylphenyl)carbamate
- Reference substance name:
- 1,1'-(4-methyl-1,3-phenylene)bis(3-(3-(aminomethyl)benzyl)urea)
- Molecular formula:
- C25H30N6O2
- IUPAC Name:
- 1,1'-(4-methyl-1,3-phenylene)bis(3-(3-(aminomethyl)benzyl)urea)
- Test material form:
- solid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
Results and discussion
In vivo
Results
- Irritation parameter:
- other: Erythema and Oedema
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results obtained, under these experimental conditions, enable to conclude that the test item ADDUKT Tl 65-MXDA, needs not to be classified, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol and risk phrase are required.
- Executive summary:
The test item ADDUKT TI 65-MXDA was applied, as supplied, at the dose of 0.5 g, under semi-occlusive dressing during 4 hours on an undamaged skin area of three rabbits. The experimental protocol was established from the O.E.C.D. guideline n°404 dated April 24th, 2002 and the test method B.4 of the directive n° 2004/73/EC.
No cutaneous reactions (erythema and oedema) were observed whatever the examination time (1, 24, 48 and 72 hours).
The results obtained, under these experimental conditions, enable to conclude that the test item ADDUKT TI 65-MXDA needs not to be classified, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol and risk phrase are required.
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