Synthetic resin, a reaction product of 4,4'-bis(N-maleimido)diphenylmethane with 3-aminobenzoic acid hydrazide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1989-10-24 to 1990-01-24

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

February 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

March, 1984

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,1'-(methylenedi-p-phenylene)bismaleimide

EC Number:

237-163-4

EC Name:

1,1'-(methylenedi-p-phenylene)bismaleimide

Cas Number:

13676-54-5

Molecular formula:

C21H14N2O4

IUPAC Name:

1,1'-[methylenedi(4,1-phenylene)]di(1H-pyrrole-2,5-dione)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: males 9 weeks, females 11 weeks
- Weight at study initiation: males 187-205 g, females 173-187 g
- Fasting period before study: 12-18 hours
- Housing: 5 animals per cage; Makrolon type-3 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz)
- Diet: ad libitum, pelleted Kliba 343, Batch 55/89 rat maintenance diet ("Kliba", Klingenmuehle AG, CH-4303 Kaiseraugst)
- Water: ad libitum, community tap water from Itingen
- Acclimation period: one week under laboratory conditions, after veterinary examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

DOSAGE PREPARATION: The test article was placed into a glass beaker on a tared Mettler PE 360 balance, and the vehicle (bi-distilled water) was added. A weight by volume dilution was prepared using a homogenizer (Ultr-Turrax, Janke and Kunkel, Staufen). Homogeneity of the test article in the vehicle was maintained during treatment using a magnetic stirrer (Janke and Kunkel, Staufen). The preparation was made immediately prior to each dosing.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations: at 1, 2, 3 and 5 h after dosing and once daily thereafter
- Frequency of weighing: Test days 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes

Statistics:

No statistics applied.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No adverse effects observed during the study

Mortality:

The following death rate was observed: 0% at 2000 mg/kg

Clinical signs:

other: Each animal was examined for changes in appearance and behavior four times during day 1, and daily during days 2-15. All abnormalities were recorded. No systemic signs were observed in any animal throughout the entire study.

Gross pathology:

Necropsies were performed by experienced prosectors. All animals were necropsied. All animals were killed by intraperitoneal injection of sodium pentobarbitone. The following macroscopical organ changes were observed: 2000 mg/kg: sacrificed - lungs: discoloration, dark red

Applicant's summary and conclusion

Interpretation of results:

not classified

Conclusions:

The acute oral toxicity of the test material in Wistar rats of both sexes, observed over a period of 15 days, was estimated to be greater than 2000 mg/kg, thus, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) with respect to acute oral toxicity.