Lithium phosphorodifluoridate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

lithium(1+) (difluorophosphoryl)oxidanide

EC Number:

643-080-8

Cas Number:

24389-25-1

Molecular formula:

LiPO2F2

IUPAC Name:

lithium(1+) (difluorophosphoryl)oxidanide

Test material form:

solid: particulate/powder

Details on test material:

Batch number: 8252153

Test animals

Species:

rat

Strain:

Wistar

Remarks:

CRL

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Young healthy adult rats, 8 weeks old
- Weight at study initiation: 165-188 g
- Fasting period before study: overnight
- Housing: 3 animals/cage (Cage type: Type II polypropylene/polycarbonate, Bedding: Lignocel® Bedding for Laboratory Animals)
- Diet (e.g. ad libitum): ssniff® SM R/M “Autoclavable complete diet for rats and mice-breeding and maintenance”, produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany ad libitum,
- Water (e.g. ad libitum): tap water from the municipal supply, as for human consumption from 500 ml bottle ad libitum.
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.1 - 23.0 °C
- Humidity (%): 31-61%
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 mg/mL and 5 mg/mL
- Lot/batch no. (if required): 3450611

MAXIMUM DOSE VOLUME APPLIED: 10mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The initial dose level was selected by the study director to be that which is most likely to produce mortality in some of the dosed animals. Based on the information provided by Sponsor, 300 mg/kg bw was selected to be the starting dose.

Doses:

300 mg/kg bw and 50 mg/kg bw (additional confirmation test at 50 mg/kg bw)

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were performed on all animals at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Statistics:

None.

Results and discussion

Preliminary study:

Initially, three females (Group 1) were treated at a dose level of 300 mg/kg bw the test substance. The test item caused the death of all animals in this group.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 50 - < 300 mg/kg bw

Based on:

test mat.

Mortality:

Treatment with test item caused the death of 3/3 animals at a dose level of 300 mg/kg bw.

Treatment with test item did not cause mortality at a dose level of 50 mg/kg bw.

Clinical signs:

other: Treatment with test item caused decreased activity, hunched back, piloerection, and decreased body temperature and prone position at a dose level of 300 mg/kg bw. Treatment with test item did not cause any test item related effect at a dose level of 50 m

Gross pathology:

Three females were found dead on Day 0 or 1. Necropsy was performed on 3/3 animals dosed at 300 mg/kg bw. Dark/red discoloration of the non-collapsed lungs and thymus did not indicate cause of death for these animals and rather were agonal/post mortem in nature than test item-related in this animals.

No macroscopic observations were noted at a dose level of 50 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

Under the conditions of this study, the acute oral LD50 value of the test item was found to be between 50 and 300 mg/kg bw in female CRL:(WI) rats.