Carbamic acid,N,N'-[1,3-phenylenebis[methyleneiminocarbonylimino(methyl-3,1-phenylene)]]bis-di-C11-14-isoalkylesters, C13-rich

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

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:

2014

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)

Version / remarks:

SEPA chemical testing methods Editorial Board. The Guidelines for Testing of Chemicals (Health Effects part) [M]. China Environmental Science Press. 2013 : 258-276

Deviations:

not specified

GLP compliance:

no

Test type:

other: infection method

Limit test:

yes

Test material

Test material information

Constituent 1

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

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

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

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:

The rats reared in stainless steel wire cages (500W x 350D x 200H mm), 5 animals were housed in a cage, every single gender in a cage Drinking water and feed were provided ad libitum. The animal rooms were cleaned once a day and autoclaved aluminum trays were replaced three times a week. During the test period, the animal room kept temperature at 21.9-23.5 'C, humidity in 51.9-59.6 %. Pressure between room and corridor was greater than 10 Pa, ventilation was more than 15 times per hour, and lighting period was 12 hours per day (8:00-20:00).

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

other: nose and mouth

Vehicle:

air

Duration of exposure:

ca. 4 h

Concentrations:

limit test at 5.0 mg/L

No. of animals per sex per dose:

10

Control animals:

not specified

Details on study design:

10 rats (5 ♂ and 5 ♀) were employed in acute inhalation toxicity test. The test animals were weighed before exposure and placed in the container. Rats were infected at the dose of 5.0 mg/L after balancing test concentration for 4 hours.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

>= 5 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No obvious toxicity and no death of test rats were showed during test, Observed and recorded during the test.

Clinical signs:

other: No obvious toxicity of test rats were observed during exposure.

Body weight:

Body weights of test rats increased significantly during the experimental period.

Gross pathology:

No obvious abnormalities of test rats induced by ADDUKT TI180-MXDA were observed by necropsy at the end of study period.

Other findings:

No obvious toxicity of test rats were observed during exposure.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance ADDUKT TI180-MXDA (batch number: #VPE 1724/18) inhalation infection at the dose of 5.0 mg/L for 4 hours observed no obvious toxicities. No obvious abnormalities of test rats induced by ADDUKT TI180-MXDA were observed by necropsy at the end of study period. The suction LC50 of test substance ADDUKT TI180-MXDA is greater than 5.0 mg/L. Under the present experimental conditions, rats were observed no obvious toxicities after infecting with the test substance ADDUKT TI180-MXDA (batch number: #VPE 1724/18) at the dose of 5.0 mg/L. The suction LC50 of ADDUKT TI180-MXDA is greater than 5.0 mg/L.

Executive summary:

Purpose:

To evaluate the toxic effects and reversibility of ADDUKT TI180-MXDA by observing functional and morphological changes after inhalation administration of ADDUKT TI180-MXDA at dose of 5.0 mg/L to SD rats. This test will also provide information for both the acute toxicity classification and sub-chronic exposure doses.

 

Method:

10 rats (5♂and 5♀) were employed in acute inhalation toxicity test. The test animals were weighed before exposure and placed in the container. Rats were infected at the dose of 5.0 mg/L after balancing test concentration for 4 hours. Animals were daily observed for 14 days. All observations from individual rat were systematically recorded. Body weight of each animal was recorded prior to administration (recorded as d0), d1, d3, d7 and d14 respectively. All test animals should be subjected to gross necropsy. The observation of heart, lung, kidney, Iiver, spleen, gastrointestinal tract and other organs were performed to make sure whether there were any hemorrhage and edema.

 

Result:

No obvious toxicities were observed on test rats infected by ADDUKT TI180-MXDA at the dose of 5.0 mg/L. Body weights increased significantly during the experimental period. No obvious abnormalities of test rats induced by ADDUKT

TI180-MXDA were observed by necropsy at the end of study period.

 

Conclusion:

Under the present experimental conditions, rats were observed no obvious toxicities after infecting with the test substance ADDUKT TI180-MXDA (batch number: #VPE 1724/18) at the dose of 5.0 mg/L. The suction LC₅₀of ADDUKT TI180-MXDA is greater than 5.0 mg/L.