Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
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:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute 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:
male/female
Details on test animals or test system and environmental conditions:
During the treatment, the animals were kept in individual cages. On D1, the animals were put into their cage by 5. The rats were kept in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains dust free weed shavings which were changed at least 2 times a week. Each cage was installed in conventional air conditioned animal husbandry. The temperature and relative humidity of the main test were controlled to remain within target ranges of 19 to 25°C and 30 to 70%, respectively. The rate of air exchange was approximately thirteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (07.00 to 19.00) and twelve hours darkness.

Administration / exposure

Type of coverage:
other: gauze dressings
Vehicle:
other: dimethylsulfoxide
Details on dermal exposure:
Approximately 24 hours before the treatment, fur was removed from the dorsal area of the trunk of the test animals by clipping. At least 10 per cent of the body surface area was clear for the application of the test item Addukt TI 65 - MXDA. 2.0053 g and 4.0012 g of the test item was weighed and dimethylsulfoxide was added to a 10 and 20 mL volumetric flask, respectively. The preparation was magnetically stirred and heated at around 50°C to obtain a whitish to yellow solution just before the administration. The preparation was administered under a volume of 10 mL/kg body weight, during 24 hours. After 24-hours exposure period, the gauze dressings were removed and the treated areas were rinsed with distilled water and paraffin oil.
Duration of exposure:
24 h
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5
Control animals:
yes
Remarks:
control group referred to historical values

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
no
Clinical signs:
No systemic 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.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of the test item Addukt TI 65 - MXDA is higher than 2000 mg/kg body weight by dermal route in the rat. 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 TI 65 - MXDA does not have to be classified. No symbol or risk phrase is required. In accordance with the Regulation EC No. 1272/2008, the test item does not have to be classified. No signal word or hazard statement is required.
Executive summary:

The test item Addukt TI 65 - MXDA was applied onto the intact skin of 10 Sprague Dawley rats (5 males and 5 females) 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 OECD guideline No. 402 dated February 24th, 1987 and the test method B.3 of the Council regulation No. 440/2008 of 30 May 2008. No mortality occurred during the study. No systemic clinical signs related to the administration of the test item were observed.

Cutaneous reactions (erythema and dryness) were noted from day 2 in all animals and were totally reversible on day 8. A white coloration of the treated site was noted from 24 hours post-dose in all animals and was totally reversible on day 2. The body weight evolution of the animals remained normal throughout the study. The macroscopic examination of the animals at the end of the study did not reveal treatment-related changes. In conclusion, the LD50 of the test item Addukt TI 65 - MXDA is higher than 2000 mg/kg body

weight by dermal route in the rat. 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 TI 65 - MXDA does not have to be classified. No symbol or risk phrase is required. In accordance with the Regulation EC No. 1272/2008, the test item does not have to be classified. No signal word or hazard statement is required.