Tetrakis(1-piperidyl)phosphonium chloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

other information

Study period:

January 25th, 2000 to February 25th, 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

92/69/EEC

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

February 24, 1987

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Test material form:

solid

Specific details on test material used for the study:

Purity: 95.6 % [w/w]

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Origin of test animals: Harlan Winkelmann GmbH, Gartenstraße 27, D33178 Borchen
SPF breeding colony
Body weight at the start of study:
Male animals 210-225 g, mean 215 g, S.D. +/- 5.8 g
Female animals 178-200 g, mean 185 g, S.D. +/- 6.2 g
Age at the start of study: 6-10 weeks

Acclimatization: at least seven days
Food: ssniff® R/M-H (V 1534), ad libitum
Photoperiod: 12 hours light / dark cycle
Relative humidity: 50 ± 20 %
Room temperature: 22 ± 3°C
Water: tap water in plastic bottles, ad libitum
Animal maintenance: in transparent macrolon® cages (type 4) on soft wood granulate in an airconditioned room, 5 animals per cage

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Application volume: 10 mL/kg body weight

Doses:

females: 63, 100, 200 mg/kg body weight
males: 200 mg/kg body weight

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

The test substance preparations were administered by gavage to fasted animals at the stated dosage. The observation period following treatment lasted for 14 days. Symptoms were recorded twice every day (in the morning and in the afternoon). Animals found dead were dissected as soon as possible and examined for macroscopically visible changes.

Statistics:

The LD50, the 95% limits of confidence and the equation of the probit line were established in female animals on the basis of the lethality rates by probit analysis. (Method of Fieller and Sidak, programs supplied by IS Research, Aventis Pharma Deutschland GmbH).

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

87.74 mg/kg bw

Based on:

test mat.

95% CL:

>= 40.94 - <= 221

Mortality:

Female animals, dose 63 mg/kg bw: 1/5
Female animals, dose 100 mg/kg bw: 3/5
Female animals, dose 200 mg/kg bw: 5/5
Male animals, dose 200 mg/kg bw: 3/5

Clinical signs:

other: Lethality occurred up to day four of the study. Besides unspecific symptoms the animals showed impairments of mobility and respiration, narrowed palpebral fissures, prone position, stupor and diarrhea. At day 5 of the study all clinical signs were disappe

Gross pathology:

Necropsy of the decedent animals revealed partly light red discoloured liver, dark red discoloured lungs, diffuse reddening of small intestine and small intestine filled with green-yellow mucous.
The animals killed at the end of the observation period showed no macroscopically visible changes.

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

Based on the results of this study the median lethal dose value (LD50) of Tetrakis(piperidino)phosphonium chloride is 87.7 mg/kg body weight in female rats.