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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 November - 12 December 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Information lacking on whether the exposure was occlusive or semi-occlusive.

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: EEC guidelines - VI Amendment, Annex V, Directive 84/449/EEC

Deviations:

yes

Remarks:

Lacking information on whether the exposure was occlusive or semi-occlusive.

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

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: Males: 225 - 250 grams. Females: 200 - 225 grams
- Housing: 1 animal/cage in air conditioned rooms. Grill cages with stainless steel feeder.
- 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): 20 / hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Dorsal and ventral area of the trunk of the test animals.
- % coverage: 10%
- Type of wrap if used: Not specified. Test report states that the treated area was covered with a porous gauze dressing fixed to the skin with tape and further covered in a 'suitable manner' to ensure that the animals could not ingest test material.

REMOVAL OF TEST SUBSTANCE
- Washing: At the end of the exposure period the test substance was wiped off.
- Time after start of exposure: 24 hours.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw

Duration of exposure:

Single administration - 24 hour exposure

Doses:

2000 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: The animals were observed on exposure day at 30 minutes, 2, 4 and 6 hours and on the following 14 days twice per day (early in the morning and late in the afternoon. Body weights were taken once pre-trial, on the administration day and on days 8 and 15.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Since no changes were found at necropsy, histological examination was not performed.

Statistics:

Since no mortality occurred at the limit dose of 2000 mg/kg, the LD50 was not calculated.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No adverse effects observed

Mortality:

No mortality occurred in the treated animals.

Clinical signs:

The rats did not show any clinical signs or change in behaviour and no reaction was observed on the application site.

Body weight:

Body weight gain of all rats was considered to be within normal limits for animals of this strain and age.

Gross pathology:

No changes were observed in the animals killed at the end of the study.

Other findings:

None reported.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

An acute dermal toxicity study, conducted according to a standard acute toxicity method and in compliance with GLP, concluded an LD50 value of ≥2000 mg/kg bw/day based on no adverse effects observed.