HDI oligomers, biuret

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31 Mar - 21 Apr 1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study conducted according to the OECD TG 401.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Cas Number:

28182-81-2

Molecular formula:

Unspecified (UVCB substance)

Constituent 2

Reference substance name:

HDI oligomers, biuret

EC Number:

939-340-8

Cas Number:

28182-81-2

Molecular formula:

(C8H12N2O2)n

IUPAC Name:

HDI oligomers, biuret

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Designation as given in study report: CD rats derived from Sprague-Dawley
- Source: Elevage Charles River France, Saint Aubin-lès-Elbeuf, France
- Age at study initiation: approx. 7 weeks
- Mean weight at study initiation: males, 163 g; females, 138 g
- Housing: in groups of 5 per sex and cage, in stainless steel cages
- Diet: UAR A 04 diet pellets (Société UAR, Epinay-sur-Orge, France), ad libitum, except for the night prior testing and during the first 3 to 4 hours following gavage.
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): 14
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test article was administered unchanged; the application volume was 4.4 mL/kg bw, corresponding to a dose level of 5000 mg/kg bw (density 1.14).
The control animals remained untreated but also were subjected to fasting as for the treated animals.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: on the day of treatment, after 30 minutes,1, 2, 4 and 6 hours following gavage; thereafter, twice a day.
- Frequency of weighing: each animal was weighed prior test initiation and once weekly thereafter.
- Necropsy of animals that died: animals that died were weighed and subjected to necropsy as soon as possible.
- Necropsy of survivors: the survivors were sacrificed (CO2) at test endingfor purpose of necropsy, and were subjected to gross pathology.

Statistics:

Student's t-test was used for statistical evaluation of body weight data.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality occurred, and no clinical symptoms indicative of toxicity were seen.

Mortality:

All animals survived.

Clinical signs:

other: No symptoms of toxicity were observed.

Gross pathology:

In the stomach of all treated males (10/10) and of 7 treated females (7/10), fragments of polymerised test article were found.
No further abnormalities were noticed at necropsy in the treated and control animals.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified