HDI oligomers, iminooxadiazindione

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:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(2001)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(6E)-3,5-bis(6-isocyanatohexyl)-6-[(6-isocyanatohexyl)imino]-1,3,5-oxadiazinane-2,4-dione

EC Number:

931-297-3

Molecular formula:

(C8H12N2O2)n

IUPAC Name:

(6E)-3,5-bis(6-isocyanatohexyl)-6-[(6-isocyanatohexyl)imino]-1,3,5-oxadiazinane-2,4-dione

Constituent 2

Reference substance name:

28182-81-2

Cas Number:

28182-81-2

IUPAC Name:

28182-81-2

Details on test material:

- Stability under test conditions: The analytical data verify that the test compound formulations are stable at room temperature for at least 2 hours.

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: HsdCpb:Wu
- Source: Harlan/Winkelmann GmbH, 33178 Borchen, Germany
- Age at study initiation: 10-12 weeks approximately
- Weight at study initiation: 157-186 g
- Fasting period before study: Food was withheld from the animals for approximately 16-24 h before administration of the test item, and animals were fed again approximately 2-4 h after administration.
- Housing: The animals were group caged conventionally in polycarbonate cages on low dust wood granulate bedding.
- Diet and water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 5
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: acetone/corn oil 1/10

Details on oral exposure:

- Administration volume: 10 mL/kg bw
- Concentration in vehicle: The test substance was formulated in acetone / corn oil 1/10 (test compound + 1 ml acetone ad 10 ml with corn oil)

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 (3 for 1st and 3 for 2nd testing)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Examinations: Deaths and overt signs of toxicity were recorded repeated times on day of dosing and daily for 14 days. Bodyweights were recorded on the day of dosing and on days 7 and 14. At the end of the study all animals were subject to gross necropsy, macroscopic abnormalities were recorded, no tissues were retained.

Statistics:

The LD50 value was estimated according to OECD TG 423 (2001).

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

A dose of 2000 mg/kg bw was tolerated by female rats without mortalities.

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

No gross pathology findings.

Applicant's summary and conclusion

Executive summary:

In an acute oral toxicity study according to OECD TG 423 female rats were given a limit dose of 2000 mg/kg bw. No mortalities, no clinical signs, no effects on weight gain and no gross pathological findings were observed. The LD50 for the test substance was therefore > 2000 mg/kg bw.