Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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:
2008

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

Constituent 1
Chemical structure
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
Constituent 2
Chemical structure
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
Constituent 3
Chemical structure
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
Constituent 4
Chemical structure
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

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

Categories Display