Registration Dossier
Registration Dossier
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EC number: 617-879-7 | CAS number: 865536-03-4
Eye irritation
Administrative data
- Endpoint:
- eye 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 405 (Acute Eye 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 / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand rabbit albino
Test system
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- 0,1 g
- Duration of treatment / exposure:
- 72 h
- Observation period (in vivo):
- 72
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Results
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0.3
- Max. score:
- 4
- Reversibility:
- other: slightlx and totally reversible
- Remarks on result:
- no indication of irritation
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 TI 65-MXDA needs not to be classified, according to the criteria for the classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directive n° 67/548, 2001/59 and 99/45. No symbol and risk phrase are required.
- Executive summary:
The test item ADDUKT TI 65-MXDA was instilled as supplied, at the dose of 0.1 g into the eye of three New Zealand rabbits. The experimental protocol was established on the basis of the official method as defined in the O.E.C.D. guideline n°405 dated April 24th, 2002 and the test method B.5 of the directive 2004/73/EC.
The ocular conjunctivae reactions observed during the study have been slight and totally reversible in the three animals: a slight redness, noted 1 hour after the test item instillation and totally reversible between D1 and D2, associated with a slight chemosis only noted I hour after the test item instillation.
In conclusion, 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 the classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directive n°67/548, 2001/59 and 99/45. No symbol and risk phrase are required
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