Bis[2-[2-(1-methylethyl)-3-oxazolidinyl]ethyl] hexan-1,2-diylbiscarbamate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978-05-16 to 1978-05-29

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bis[2-[2-(1-methylethyl)-3-oxazolidinyl]ethyl] hexan-1,2-diylbiscarbamate

EC Number:

261-879-6

EC Name:

Bis[2-[2-(1-methylethyl)-3-oxazolidinyl]ethyl] hexan-1,2-diylbiscarbamate

Cas Number:

59719-67-4

Molecular formula:

C24H46N4O6

IUPAC Name:

bis[2-(2-isopropyl-1,3-oxazolidin-3-yl)ethyl] hexane-1,6-diylbiscarbamate

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 9 weeks
- Weight at study initiation: 160 - 180 g
- Fasting period before study: No data
- Housing: Makrolon cages Typ III with dust free wood granulate, 5 animals /cage
- Diet: Altromin R 1324 ad libitum
- Water: Tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1.5 °C
- Humidity: 60 ± 5 %
- Photoperiod: 12 hrs light/dark (artificial lighting from 7 to 19 o`clock)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

poloxamer

Remarks:

Lutrol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 5 g/kg

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10 male animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Other examinations performed: Clinical signs

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

discriminating dose

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No animal died at the single oral administration 5000 mg/kg/bw of Incozol 4.

Clinical signs:

other: In all animals an increased diuresis was observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral toxicity LD50 on Wistar rats of the test item Incozol 4 was determined to be >5000 mg/kg bw.

Executive summary:

The acute oral toxicity test of the test item Incozol 4 was investigated in male Wistar TNO W 74 rats. The animals were held in makrolon cages with 5 animals/cage. In total 10 male animals were used. The substance was solved in Lutrol (Poloxamer) and a single dose of 5000 mg/kg bw was conducted by gavage. Water and diet feed was given ad libitum. The animals were observed for a period of 14 days.

There were no dead animals after the observation period but in all animals an increased diuresis was observed. Therefore the LD50 of Incozol 4 was determined to be > 5000 mg/kg bw.