Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Chemical structure
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.