HDI oligomers, uretdione

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study meets generally accepted scientific principles, acceptable for assessment: non-GLP, limited documentation, no data on purity of test substance, no necropsy.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

, no necropsy performed

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-[6-(3-{6-[3-(6-formamidohexyl)-2,4-dioxo-1,3-diazetidin-1-yl]hexyl}-2,4-dioxo-1,3-diazetidin-1-yl)hexyl]formamide; N-{6-[3-(6-formamidohexyl)-2,4-dioxo-1,3-diazetidin-1-yl]hexyl}formamide

EC Number:

931-288-4

Molecular formula:

(C8H12N2O2)n

IUPAC Name:

N-[6-(3-{6-[3-(6-formamidohexyl)-2,4-dioxo-1,3-diazetidin-1-yl]hexyl}-2,4-dioxo-1,3-diazetidin-1-yl)hexyl]formamide; N-{6-[3-(6-formamidohexyl)-2,4-dioxo-1,3-diazetidin-1-yl]hexyl}formamide

Constituent 2

Reference substance name:

28182-81-2

Cas Number:

28182-81-2

IUPAC Name:

28182-81-2

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: Wistar TNO W 74
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 9-14 weeks
- Mean weight at study initiation: males 182 g, females 167 g
- Housing: in groups (5 animals per cage) in Makrolon Type III cages
- Diet and water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1.5 °C
- Humidity (%): 60 +/- 5 %
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5 mL/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: several times on day of administration, twice daily within 14-days postobservation period, except for weekends (once daily)
- Frequency of weighing: on day of administration and at the end of the 14-days postobservation period
- Necropsy of survivors performed: no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Remarks on result:

other: corresponding to > 5665 mg/kg bw (relative density at 20°C 1.133 g/mL)

Mortality:

No mortality observed

Clinical signs:

other: No clinical signs observed

Gross pathology:

not performed

Applicant's summary and conclusion

Executive summary:

In an acute oral toxicity study similar to OECD TG 401 5 male and 5 female rats received each a limit dose of 5 ml/kg bw. No mortality, no clinical signs and no effect on body weight gain was observed during treatment and the 14-days postobservation period. Necropsy was not performed in the study. The LD50 was determined to be > 5 ml/kg bw (corresponding to > 5665 mg/kg bw; relative density at 20°C 1.133 g/mL)