Acetic acid, 2-cyano-, 1,1'-[2,2-bis[[(cyanoacetyl)oxy]methyl]-1,3-propanediyl] ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study conducted in accordance with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

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 tris (Acute Oral Toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Remarks:

Department of Toxicology of BASF Aktiengesellschaft

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Pentaerythritoltetracyanoacetic ester

EC Number:

605-830-2

Cas Number:

178671-69-7

Molecular formula:

C17 H16 N4 O8

IUPAC Name:

Pentaerythritoltetracyanoacetic ester

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Age at study initiation: Young adult animals
- Weight at study initiation: 150g -300g
- Fasting period before study: at least 16 hours
- Housing: Single housing in Stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG)
- Diet: Kliba-Labordiät, Klingentalmühle AG Kaiseraugst, Switzerland, ad libitum
- Water: Tap water ad libitum per day
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.5 % Tylose CB 30.000 in aqua bidest.

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20g/100ml
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: Aqueous formulation corresponds to the physiological medium.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Based on the physical and chemical characteristics of the test substance and the composition no pronounced acute oral toxicity was expected. Therefore a dose of 2000 mg/kg body weight has been chosen in a first step with 3 female animals.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: male animals were weighed on day 0 (before application), 7 and 13, female animals were weighed on days 0 and 7.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no mortalities occured.

Clinical signs:

other: Signs of toxicity were not noted.

Gross pathology:

Na abnormalities were noted at necropsy af animals sacrificed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

The median lethal dose of the test substance after oral application was found to exceed 2000 mg/kg body weight for male and female animals.

Executive summary:

In an acute oral toxicity study performed according to OECD guideline 423 and in compliance with GLP, the test substance was applied as a suspension in 0.5 % Tylose CB 30.000 in aqua bidest to male and female Wistar rats. A group of three males and three females recieved a single oral dose of the test material at a dose level of 2000 mg/kg body-weight. Signs of toxicity were not noted.

The expected body weight gain was observed during the course of the study. No mortality occurred. No abnormalities were noted at necropsy of animals sacrificed at the end of the study. Therefore, the median lethal dose of the test substance after oral application was found to be greater than 2000 mg/kg body weight for male and female animals.