HDI oligomers, isocyanurate

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:

2004

Report date:

2004

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:

28182-81-2

Cas Number:

28182-81-2

IUPAC Name:

28182-81-2

Constituent 2

Reference substance name:

HDI oligomers, isocyanurate

EC Number:

931-274-8

Cas Number:

28182-81-2

Molecular formula:

(C8H12N2O2)n

IUPAC Name:

HDI oligomers, isocyanurate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: Sprague Dawley CD (Crl: CD (SD) IGS BR)
- Source: Charles River Ltd, Margate, Kent, UK.
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: The bodyweights fell within an interval of +/- 20% of the mean initial bodyweight of the first treated group.
- Housing: in groups of 3 in suspended solid-floor polypropylene cages furnished with woodflakes.
- Fasting period before study: An overnight fast immediately before dosing and for approximately three to four hours after dosing.
- Diet and water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%):30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

ADMINISTRATION VOLUME APPLIED: 10 mL/kg

VEHICLE
- Arachis oil BP; For the purpose of the study the test material was freshly prepared, as required, as a solution at the appropriate concentration in arachis oil BP.
- Concentration in vehicle: 200 mg/mL

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: After surveying all available information on the toxicity of the test material, 2000 mg/kg was chosen as the starting dose.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 (3 animals per step)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 30 min., 1, 2 and 4 hours after dosing and subsequently once daily
- Frequency of weighing: prior to dosing and seven and fourteen days after treatment or at death.
- Necropsy of survivors performed: yes

Statistics:

Using the mortality data obtained, an estimate of the acute oral median lethal dose of the test material was made according to the scheme of OECD TG 423.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Mortality:

There were no deaths.

Clinical signs:

other: There were no signs of systemic toxicity.

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Executive summary:

An acute oral toxicity study according to the Acute Toxic Class Method (OECD TG 423) was performed on 3 + 3 female rats, receiving each a single dose of 2000 mg/kg of the substance. No mortalities, no signs of systemic toxicity and no effects on body weight gain were observed. At necropsy no abnormalities were noted. The LD50 of the test material was estimated according to the flow chart of the OECD TG 423, Annex 2d to be > 2500 mg/kg bw.