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Administrative data

Endpoint:
acute toxicity: oral
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 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method

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

Species:
rat
Strain:
Sprague-Dawley
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Details on oral exposure:
singel dose
Doses:
dose of 2000 mg/kg body weight
No. of animals per sex per dose:
6
Control animals:
not specified

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality occurred during the study
Clinical signs:
No clinical signs related to the administration of the test item were observed.

Body weight:
The body weight evolution of the animals remained normal throughout the study.
Gross pathology:
The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of the test item ADDUKT TI65-MXDA is higher than 5000 mg/kg body weight by oral route in the rat, in accordance with the OECD guideline n°423. According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the test item ADDUKT TI65-MXDA must not be classified. No symbol and risk phrase are required. In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must not be classified in category 4. No signal work and hazard statement are required.
Executive summary:

The test item ADDUKT TI65-MXDA was administered by oral route to a group of 6 female Sprague Dawley rats at the single dose of 2000 mg/kg body weight. The experimental protocol was established on the basis of the official method as defined in the O.E.C.D. guideline N°423 dated December 17th,2001 and the test method B.1 tris of the Directive N°2004/73/EC. No mortality occurred during the study. No clinical signs related to the administration of the test item were observed. The body weight evolution of the animals remained normal throughout the study. The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes. In conclusion, the LD50of the test item ADDUKT TI65-MXDA is higher than 5000 mg/kg body weight by oral route in the rat, in accordance with the OECD guideline N°423. According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the test item ADDUKT TI65-MXDA must not be classified. No symbol and risk phrase are required. In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must not be classified in category 4. No signal work and hazard statement are required.

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