2,4,6-tri-n-propyl-2,4,6-trioxo-1,3,5,2,4,6-trioxatriphosphorinane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995-07-20 to 1995-08-03

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: PPA 4/94
- Expiration date of the lot/batch: June 1996
- Purity test date: 1995-03-06

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: darkness, room temperature, in a fume cupboard
- Stability under test conditions: stable
- Solubility and stability of the test substance in the vehicle: stable for 4 h

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: the compound was administered as a 50 % solution in DMSO

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF breeding colony
- Age at study initiation: males approx. 7 weeks, females approx. 8 weeks
- Weight at study initiation: 167 +/- 2 g (males) and 163 +/- 3 g (females)
- Fasting period before study: 16 h
- Housing: makrolon cages in fully air conditioned rooms, on soft wood granulate in groups of 5
- Diet: ad libitum ssniff R/M-H (V1534)
- Water: tap water ad libitum, plastic bottles
- Acclimation period: not anecessary as breeded at identical conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3 °C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1995-07-20 To: 1995-08-03

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

DMSO

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50 %

Doses:

one (limit) dose of 2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Symptoms were recorded twice daily, on weekends and holidays once. The animals were weighed weekly.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, macroscopically visible changes

Statistics:

no statisitical analysis performed as all findings were reversible

Results and discussion

Preliminary study:

not applicable

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: The following clinical signs were observed: reduced spontaneous activity, hunched posture, drawn in sides, pilo erection, high gait and unregular breathing. In the females additionally reduced palpebral fissure and uncoordinated gait observed. 2 days

Gross pathology:

Effects on organs:
The animals killed at the end of the observation period showed no macroscopically visible changes.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 value of the test item was determined to be >2000 mg/kg bw.

Executive summary:

To assess the acute oral toxicity of the test substance, a single (limit) dose of 2000 mg/kg bw was administered as a 50 % solution in DMSO to 5 male and 5 female Wistar rats via gavage. The study was conducted according to OECD Guideline 401 (1987). During the 14 days observation period clinical signs of toxicity and body weight changes were recorded. No deaths occurred during the study. The following clinical signs were observed: reduced spontaneous activity, hunched posture, drawn in sides, piloerection, high gait and unregular breathing. In the females additionally reduced palpebral fissure and uncoordinated gait observed. All effects were reversible within two days. At necropsy, no macroscopical changes were found. Based on the available data, the LD50 value of the test item was determined to be > 2000 mg/kg bw.