reaction product of diphenylmethanediisocyanate, toluenediisocyanate ( reaction mass of isomers: 65 % 2,4- and 35 % 2,6-diisocyanate), octylamine, oleylamine and 4-ethoxyaniline (molar ratio 3.88:1:6.38:0.47:2.91)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999-01-18 to 1999-02-03

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

adopted 22. March, 1996

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

EPA 712-C-96-190, June 1996

Deviations:

no

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:

-

EC Number:

430-970-4

EC Name:

-

Cas Number:

1266545-66-7

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

Reaction product of (C8 – C18) aliphatic primary amines (partly unsaturated) and p-phenetidine with a mixture of aromatic isocyanates comprising of primarily 4,4’-methylenediphenyl diisocyanate and 4-methyl-m-phenylene

Details on test material:

NA

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan, Winkelmann GmbH, D-33178 Borchen
- Weight at study initiation: female 127-138 g; male 145-153 g
- Fasting period before study: over night
- Housing: Macrolon cages on Altromin saw fibre bedding
- Diet: ad libitum, Altromin 1324 totally-pathogen-free-TPF
- Water : tap water: drinking water, municipal residue control, microbiol. controlled periodically
- Acclimatisation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3°C
- Humidity: 55 ± 10%
- Air changes: 10x per hr
- Photoperiod : 12/12 hrs dark / hrs light (light 6.00 - 18.00)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

1 % in aqua bidest.

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: The vehicle was chosen due to its non-toxic characteristics
- Lot/batch no.: 36H0738

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 animals per sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: careful clinical examination twice a day on the day of dosing and once a day thereafter; animals weighed prior to first application and once a week thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: changes in the skin, fur, eyes and mucous membranes. Changes in respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality

Clinical signs:

other: No compound related toxicity/signs. No weight loss was recorded. The weight gain for the male animals was within the expected range. The female rats showed a slightly diminished weight gain.

Gross pathology:

No compound related macroscopic necropsy findings were recorded.

Applicant's summary and conclusion

Interpretation of results:

not classified

Conclusions:

LD50 > 2000 mg/kg bw

Executive summary:

The test substance was tested for its acute oral toxicity in a limit test according to EU Method B.1, OECD Guideline 423 and EPA OPPTS 870.1100. The test substance was administered in a dose of 2000 mg/kg bw (limit dose) to groups of 3 male and 3 female Wistar rats in a single exposure via gavage. No mortality and no clinical signs of toxicity were observed within the 14 days observation period. Additionally, no gross pathological changes were recorded at necropsy. The LD50 value was determined greater 2000 mg/kg bw based on the available data.