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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

Constituent 1
Chemical structure
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.