Carbamic acid, N,N'-[1,3-phenylenebis[methyleneiminocarbonylimino(methyl-3,1-phenylene)]]bis-, di-C10-14-alkyl esters

Acute Toxicity: oral

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:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

yes

Remarks:

5 male and 5 female rats in one step with two doses

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

428-710-1

EC Name:

-

Cas Number:

207574-76-3

Molecular formula:

C46H68N6O6 / C48H72N6O6 / C50H76N6O6 / C52H80N6O6 / C54H84N6O6

IUPAC Name:

Condensation products of m-phenylenebis(methylamine) with condensation products of 4-methyl-m-phenylene diisocyanate with alcohols, C10-14 (even numbered)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- SPF-Wistar rats, strain Winkelmann, Paderborn
- Mean body weight male: 210 - 230 g
- Mean body weight female: 190 - 210 g
- Fasting period before study: 16 hours
- Housing: animals were kept in groups of 5 male and 5 female "at random" divided in single cages
- Diet: laboratory standard diet (Altromin, Lage), ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 22.5 ± 2.5 °C
- Humidity: 40 - 60 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

Administration by oral gavage, using a non-flexible stomach tube, as 10% suspension in 1% CMC.

VEHICLE
- Concentration in vehicle: 10 %


MAXIMUM DOSE VOLUME APPLIED:
- Dosage level 2000 mg/kg bw: 2.0 ml/100 g bw
- Dosage level 5000 mg/kg bw: 5.0 ml/100 g bw

Doses:

2000 and 5000 mg/kg bodyweight

No. of animals per sex per dose:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weekly weighing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Statistics:

Not applicable. No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

During the study, no mortality could be observed.

Clinical signs:

other: No clinical signs of toxicity were observed during the study.

Gross pathology:

No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: not classified according to Regulation (EC) 1272/2008.

Conclusions:

The oral LD50 value of the test item in Wistar rats was established to exceed 5000 mg/kg body weight. Based on these results and according to the EC criteria for classification and labelling according to CLP (Regulation (EC) No. 1272/2008), the test item does not have to be classified and has no obligatory labelling requirement for oral toxicity.

Executive summary:

The test item did not show any mortality in rats up to 5000 mg/kg bodyweight and is therefore considered practically non-toxic.