Pentapotassium ({[(hydroxyphosphinato)methyl](phosphonatomethyl)nitroryl}methyl)phosphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 January 1991 - 05 February 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: ECC guideline - VI Amendment, Annex V, Directive 84/449/EEC

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

pentapotassium {[(hydrogen phosphonomethyl)(phosphonomethyl)-oxo-$l^{5}-azanyl]methyl}phosphonate

EC Number:

700-903-6

Cas Number:

255830-15-0

Molecular formula:

C3H7K5NO10P3

IUPAC Name:

pentapotassium {[(hydrogen phosphonomethyl)(phosphonomethyl)-oxo-$l^{5}-azanyl]methyl}phosphonate

Constituent 2

Reference substance name:

ATMP-N-oxide-5K

IUPAC Name:

ATMP-N-oxide-5K

Details on test material:

- Name of test material (as cited in study report): Sequion CLR

- Physical state: colourless liquid

- Storage condition of test material: in a glass bottle, no specific requirements

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Italia S.p.A., Via Indipendenza, 11, 22050 - CALCO (Como)
- Age at study initiation: ca. 7-9 weeks
- Weight at study initiation: 225-250 grams (males), 200-225 grams (females)
- Fasting period before study: 16 hours (Volume of dosing was based on day 1 bodyweight. Feed was returned to rats three hours after the test article administration).
- Housing: 5 animals/sex/cage in air-conditioned rooms, in grill cages with stainless steel feeders.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Minimum of 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 °C
- Humidity (%): 55 +/- 10 %
- Air changes (per hr): ca. 20 / hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
Just before the treatment of the animals a weighed amount of the test article was dissolved with the suitable volume of deionized water.

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

Doses:

5000 mg/kg

No. of animals per sex per dose:

5 males, 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Observations took place at 30 minutes, 2, 4 and 6 hours on the first day after the administration and then twice a day up to the termination of the observation period. Body weights were taken once pre-trial and on days 1, 3, 8 and 14. On day 1 the animals were weighed after a 16 hour fasting.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Histological examination was not performed as no macroscopic findings emerged from necropsy.

Statistics:

The LD50 calculation was not possible.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 5 000 mg/kg bw

Based on:

dissolved

Remarks on result:

other: No adverse effects observed

Mortality:

There were no deaths.

Clinical signs:

Hypoactivity, shallow breathing, piloerection and hunched posture were the main clinical signs observed starting from 30 minutes and lasting up to 2 days after the test article administration. Recovery of all treated animals was achieved 3 days after treatment.

Body weight:

The body weight gain of all the treated animals was considered within normal limits for rats of this strain and age (except for one female rat which showed a slight decrease in body weight gain only at the day 3 weighing).

Gross pathology:

No changes were noted in any of the necropsied animals.

Other findings:

None reported.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

An acute oral toxicity study, conducted according to a standard acute toxicity method and in compliance with GLP, concluded an LD50 value of ≥5000 mg/kg bw/day based on no adverse effects.