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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

Constituent 1
Chemical structure
Reference substance name:
HDI oligomers, uretdione
EC Number:
931-288-4
Molecular formula:
(C8H12N2O2)n
IUPAC Name:
HDI oligomers, uretdione
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:
No clinical signs observed
Body weight:
No effect on body weight gain 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)