Registration Dossier

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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
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

Constituent 1
Chemical structure
Reference substance name:
Lithium phosphorodifluoridate
EC Number:
643-080-8
Cas Number:
24389-25-1
Molecular formula:
LiPO2F2
IUPAC Name:
Lithium phosphorodifluoridate
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:
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 mg/kg bw.
Body weight:
Body weight gains of test item treated animals did not show any test item related effect during the study.
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.