Propanoic acid, 2-cyano-2-methyl-, methyl ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005-01-17 to 2005-06-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

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:

December 17, 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

June 16, 2004

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

December 2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-cyano-2-methyl-propanoic acid methyl ester

EC Number:

615-749-4

Cas Number:

72291-30-6

Molecular formula:

C6 H9 N O2

IUPAC Name:

2-cyano-2-methyl-propanoic acid methyl ester

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd Laboratory Animal Services, Wölferstrasse 4, CH-4414 Füllinsdorf, Switzerland
- Age at study initiation: Young adult female animals, approx 8 -12 weeks
- Weight at study initiation: 173 -180 g
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum
- Housing: Single housing, stainless steel wire mesh cages, type DK-III (Becker & Co ., Castrop-Rauxel, FRG)
- Diet: Kliba-Labordiät (Maus / Ratte Haltung "GLP"), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland, ad libitum
- Water: Tap water ad libitum
- Acclimation period: Acclimatization for at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 h / 12 h (6.00 a.m. - 6 .00 p.m . / 6 .00 p .m. - 6.00 a.m.)

IN-LIFE DATES: From: January 14, 2005 To: February 16, 2005

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

The test substance was administered as an emulsion (administration volume: 5 mL/kg).

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

3 females at 300 mg/kg; 6 females at 2000 mg/kg

Control animals:

no

Details on study design:

Individual body weights were recorded shortly before administration, thereafter weekly and at the end of the study.
Recording of signs and symptoms were made several times on the day of administration, at least once each working day for the individual animals.
A check for any dead or moribund animal was made twice each working day and on Saturdays, Sundays and on public holidays.
Necropsy with gross-pathological examination on the last day of the observation period after killing by CO2 inhalation.
Observation period: 14 days

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

none

Body weight:

The mean body weights was increased throughout the study period.

Gross pathology:

nothing abnormal detected