Tetraethyl 2,2'-(1,4-phenylenedimethylidyne)bismalonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant Guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tetraethyl 2,2'-(1,4-phenylenedimethylidyne)bismalonate

EC Number:

228-726-5

EC Name:

Tetraethyl 2,2'-(1,4-phenylenedimethylidyne)bismalonate

Cas Number:

6337-43-5

Molecular formula:

C22H26O8

IUPAC Name:

1,3-diethyl 2-({4-[3-ethoxy-2-(ethoxycarbonyl)-3-oxoprop-1-en-1-yl]phenyl}methylidene)propanedioate

Test material form:

other: solid

Test animals

Species:

rat

Strain:

other: HanBrl: Wist (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd. CH-4414 Füllinsdorf, Switzerland
- Age at study initiation: males - 8 weeks; females - 10 weeks
- Fasting period before study: 17 to 18 hours
- Housing: in groups of three per sex in Makrolon type-4 cages with wire mesh tops and standardized softwood bedding
- Diet (e.g. ad libitum): pelleted standard Provimi Kliba 3422 rat maintenance diet, ad libitum
- Water (e.g. ad libitum): community tap water from Füllinsdorf, ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 5. Feb. To: 31. Jan. 2002

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: based on solubility testing
- Lot: 424718/1 42701

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

Number of animals per group: 3 males or 3 females
Total number of animals: 3 males, 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
clinical signs - daily
body weights - day 1, 8 and 15
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Median lethal dose after single oral administration to rats of both sexes, observed over a period of 14 days

Mortality:

No death occurred during the study.

Clinical signs:

other: No clinical signs were noted during the course of the study.

Gross pathology:

No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The median lethal dose of the test item after single oral administration to rats of both sexes, observed over a period of 14 days is LD50 (rat) > 2000 mg/kg body weight.

Executive summary:

The acute oral toxicity of the test substance to rats was investigated in a study conducted according to OECD Guideline 423. The median lethal dose of the test item after single oral administration to rats of both sexes, observed over a period of 14 days is LD50 (rat) > 2000 mg/kg body weight.