Lithium tetrafluoroborate, anhydrous

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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:

2019

Report date:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Test material

Test material information

Constituent 1

Reference substance name:

Lithium tetrafluoroborate, anhydrous

EC Number:

238-178-9

EC Name:

Lithium tetrafluoroborate, anhydrous

Cas Number:

14283-07-9

Molecular formula:

BF4.Li

IUPAC Name:

lithium tetrafluoroborate, anhydrous

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Age at First Dose At least 8-10weeks; female animals were non-pregnant and nulliparous
Animal Health The health condition of animals was examined by a veterinarianbefore initiation of the study.
Acclimation The animals were acclimated to the condition identical to the conditions during the experiment 5 days prior to the start of treatment. The acclimation was according to the standard operation procedure.
Housing Condition The animals were housed in plastic cages suspended on stainless steel racks, 1-3 animals per cage (after application of the test item animals were caged individually) in a room equipped with central air-conditioning. The average room temperature was maintained within the range of 22 ± 3°C, relative humidity within 50-60%. The light regimen was set to a 12-hour light /12-hour dark cycle. The sanitation was performed according to the standard operation procedures.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Approximately 24 hours before the test, fur was removed from the dorsal area of the trunk of the test animals by clipping and shaving. A precise amount of the test item was aspirated into an adjustable pipette and applied directly on the shaved skin of the back in a single dose uniformly over an area approximately 10 % of the total body surface area. Test item was held in contact with the skin by using semi-occlusive dressing with non-irritating tape throughout the 24-hours exposure period. At the end of the exposure period, any residuals of the test item were removed by using lukewarm water without altering the existing response or integrity of the epidermis.

Duration of exposure:

24-hours exposure

Doses:

50, 200, 1000, and 2000 mg/kg body weight

No. of animals per sex per dose:

3 females

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All,3/3 females survived the limit dose of 2000 mg/kgbody weight.

Clinical signs:

other: All,3/3 females survived the limit dose of 2000 mg/kgbody weight. No signs of intoxication, change of health, nor any adverse reactions during 14-days observation period

Other findings:

All animals were necropsied. During necropsy, no macroscopic changes were noticed.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The LD50 of the test item Lithium Tetrafluoroborateis greater than 2000 mg/kg body weight after single dermal application to Wistar rats.
Based on OECD Test Guideline 402 Acute Dermal Toxicity: Fixed Dose Procedure it can be concluded, that the test item Lithium Tetrafluoroborate according to the Globally Harmonised System can be classified in Category 5/Unclassified after single dermal application to Wistar rats.