Phosphine, tris(5-chloro-2-methoxyphenyl)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to OECD guidelines No. 420 “Acute Oral Toxicity – Fixed Dose Method” and in accordance with GLP.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Principles of method if other than guideline:

Guideline followed.

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report)
- Physical state: White powder
- Analytical purity: 99.5%
- Storage condition of test material: Room temperature in the dark.

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Ltd, Oxon, UK.
- Age at study initiation: 8-12 weeks (All the females were nulliparous and non-pregnant)
- Weight at study initiation: Animal No. 1- 164 g; Animal No. 2-157 g; Animal No. 3-171 g; Animal No. 4-174 g; Animal No. 5-167 g.
- Fasting period before study: overnight fasting immediately before dosing.
- Housing: The animals were housed in groups of up to 4 in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 Deg C
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: Arachis oil BP was used because the test item did not dissolve/suspend in distilled water.


MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bodyweight

DOSAGE PREPARATION (if unusual): The test item was freshly prepared , as required as a suspension in arachis oil with in two hours of dosing.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Using available information on the toxicity of the test item, 2000 mg/kg bodyweight was chosen as a starting dose on single animal.
In the absence of mortality or evident toxicity at a dose level of 2000 mg/kg, an additional group of 4 animals was treated with 2000 mg/kg bodyweight.

Doses:

Single dose of 2000 mg/kg bodyweight.

No. of animals per sex per dose:

4 female animals for single fixed dose of 2000 mg/kg bodyweight.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made 30 min, 1, 2 and 4 hour after dosing and subsequently once daily for 14 days. Morbidity and mortality checks were made twice daily.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

None

Results and discussion

Preliminary study:

No mortality or evident toxicity observed at a dose level of 2000 mg/kg bodyweight.

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality or sign of evident toxicity observed

Mortality:

No mortality

Clinical signs:

other: No signs of systemic toxicity observed

Gross pathology:

No abnormalities noted

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater that 2000mg/kg bodyweight.

Executive summary:

The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat following OECD TG No. 420. Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of the test item, as a suspension in arachis oil BP, at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

Mortality: There were no deaths.

Clinical observations: There were no signs of systemic toxicity.

Bodyweight: All animals showed expected gains in bodyweight.

Necropsy: No abnormalities were noted at necropsy.

CONCLUSION: The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater that 2000 mg/kg bodyweight