[(2E)-3-(5,5-dimethyl-1,3-dioxan-2-yl)-2-butenyl]triphenylphosphonium chloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Cited as Directive 84/449/EEC, B.1 (modified according to the acute toxic class method)

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

[(2E)-3-(5,5-dimethyl-1,3-dioxan-2-yl)-2-butenyl]triphenylphosphonium chloride

EC Number:

613-004-8

Cas Number:

62285-89-6

Molecular formula:

C28 H32 O2 P . Cl

IUPAC Name:

[(2E)-3-(5,5-dimethyl-1,3-dioxan-2-yl)-2-butenyl]triphenylphosphonium chloride

Details on test material:

- Name of test material (as cited in study report): C5-NPG-ACETAL
- Substance Number: 92/128
- Physical state: white powder
- Analytical purity: 99 %
- Lot/batch No.: 92/33 - 1 (TECHNIKUM B 15 S)
- Stability under test conditions: The stability of the test substance in aqua bidest. for at least 4 hours was confirmed by analysis.
- Storage condition of test material: refrigerator; exclusion of moisture

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: 150g - 300g 20% of the mean weight
- Fasting period before study: the animals were given no feed at least 16 hours before administration, but water was available ad libitum.
- Housing: single housing
- Diet (e.g. ad libitum): Diet: Kliba-Labordiaet 343, Klingentalmuehle AG, Kaiseraugst, Switzerland, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- 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:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2 g / 100 mL and 20 g / 100 mL
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: aqueous formulation corresponds to the physiological medium

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

Doses:

200 and 2000 mg / kg body weight

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:
- Body weight determination: individual body weights shortly before application (day 0), weekly thereafter and at the end of the study (before fating period)
- Signs and symptoms serveral times on the day of administration, at least once each workday for the individual animals
- General observations and Mortality: A check was made twice each workday and once on saturdays, sundays and on public holidays for
general observations and for any dead or moribund animals.
- Necropsy of survivors performed: yes, at the last day of the observation period. Withdrawal of food at least 16 hours before killing with C02; then necropsy with grosspathology examination. Necropsy of all animals that died before as early as possible.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 200 - < 2 000 mg/kg bw

Remarks on result:

other: At the concentration of 2000 mg /kg body weight all animals died.

Mortality:

200 mg / kg body weight: Males: No animal died; Females: One animal of 3 died within 1 hour.
2000 mg / kg body weight: Males: all animals died immediately after gavage.

Clinical signs:

Females: 200 mg / kg body weight: poor general state (2 animals, hour 4 to day 1); dyspnoea (2 animals; hour 4 to day 1); apathy (2 animals, hour 4 to day 1); staggering (1 animal, hour 4 to day 1); piloerection (2 animals, hour 1 to day 1); diarrhea (2 animals, hour 1 to hour 4).

Males:
- 200 mg / kg body weight: poor general state (3 animals, hour 0 to day 9); dyspnoea (3 animals; hour 0 to day 9); apathy (3 animals, hour 0 to day 9); staggering (3 animals, day 1 to 9); ataxia (3 animals, day 5 to 9); tremor (1 animal, day 1); piloerection (3 animals, hour 0 to day 9); smeared fur (3 animals, day 9); exsiccosis (3 animals, day 5 to 8); discoloured urine (1 animals, day 1 to 2).
- 2000 mg / kg body weight: poor general state (3 animals, hour 0); dyspnoea (2 animals; hour 0); gasping (3 animals, hour 0); apathy (3 animals, hour 0); abdominal position (2 animals, hour 0); lateral position (1 animal, hour 0); cyanosis (3 animals, hour 0); salivation (1 animal, hour 0).

Body weight:

Males: No effects.

Gross pathology:

Animals that died:
- general congestion: 200 mg / kg body weight: one female; 2000 mg / kg body weight: 3 males;
- liver: marked black-red discolouration: 2000 mg / kg body weight: 3 males;

Sacrificed animals:
- no pathological findings in 3 males and 2 females of the low dose group.

Other findings:

No other findings.