Lithium tetrafluoroborate, anhydrous

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

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

Administration / exposure

Route of administration:

oral: feed

Doses:

The test was initially conducted with the dose of 300 mg kg-1 of body weight, following the flowchart shown in Appendix 2 .This starting dose was based on historical information from studies carried out with the same active ingredient and data from literature. The time interval between treatment groups was determined according to the duration and severity of signs of toxicity.

No. of animals per sex per dose:

9

Results and discussion

Preliminary study:

The oral LD50 value of test substance Lithium Tetrafluoroborate, for female rats, was estimated to be 500 mg kg-1 of body weight.

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 500 mg/kg bw

Clinical signs:

other: The systemic signs of toxicity in the animals exposed to the substance test by the oral route at the doses of 300 and 2000 mg Kg-1 of body weight are shown in Table 2.

Other findings:

The results of the animals necropsied at study are presented in Table 3.

Any other information on results incl. tables

Table 1 –Individual body weight and information about the test substance administred.

 

Treatment	Dose (mg kg^-1)	Animal #	Body Weight (g)					Date and time of death	Administered quantity (mL)	Date and hour of application
			Initial (Day 0)	Day 7	Day 14	Difference between final and initial weight	Deaths
1^st	300	1	229,66	239,89	252,07	22,41	-	-	0,14	27/Feb/2018 08:30 a.m.
		2	233,41	243,14	252,83	19,42	-	-	0,14
		3	205,81	233,40	243,99	37,18	-	-	0,12
2^nd	300	1	221,63	239,73	246,37	24,74	-	-	0,14	01/Mar/2018 08:33 a.m.
		2	192,04	209,05	213,70	21,66	-	-	0,12
		3	226,71	240,02	251,61	24,90	-	-	0,14
3^rd	2000	1	213,26	-	-	-	213,20	06/Mar/2018 10:06	0,86	06/Mar/2018 08:36 a.m.
		2	217,40	-	-	-	215,36	06/Mar/2018 10:06	0,86
		3	200,53	-	-	-	196,72	06/Mar/2018 10:06	0,80

Table 2 –Behavioral and clinical alterations observed during the experimental period.

 

Treatment	Step	Sex	Animal #					observation day
				0				1	2	3	4	5	6	7	8	9	10	11	12	13	14
				0:30h*	10:40 a.m.	12:00 p.m.	14:30 p.m.
300	1	♀	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
			2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
			3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Treatment	Step	Sex	Animal #					observation day
				0				1	2	3	4	5	6	7	8	9	10	11	12	13	14
				0:30h*	10:00 a.m.	11:40 a.m.	15:00 p.m.
300	2	♀	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
			2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
			3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Treatment	Step	Sex	Animal #					observation day
				0				1	2	3	4	5	6	7	8	9	10	11	12	13	14
				0:30h*	10:06 a.m.
2000	3	♀	1	1;5	12	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
			2	1;5	12	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
			3	1;5	12	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-

Legend:

0.            none visual alterations observed;

1.            Piloeretion;

2.            Mucous membranes alterations;

3.            Respiratory system alteration;

4.            System circulation alteration;

5.            Ataxia;

6.            Behavior pattern alteration;

7.            Convulsions;

8.            Salivation;

9.            Diarrhea;

10.          Lethargy;

11.          Tremble;

12.          Death.

*.      After application of test substance

 Table 3 –Pathological findings in animals at doses of 300 and 2000 mg kg^-1of body weight.

Treatment	Dose (mg kg^-1)	Animal #	Macroscopic Alterations
			Skin	Brain	Eyes	Lungs	Heart	Liver	Spleen	Urinary system	G.I.T	R.T	Carcass
1^st	300	1	0	0	0	0	0	0	0	0	0	0	0
		2	0	0	0	0	0	0	0	0	0	0	0
		3	0	0	0	0	0	0	0	0	0	0	0
2^nd	300	1	0	0	0	0	0	0	0	0	0	0	0
		2	0	0	0	0	0	0	0	0	0	0	0
		3	0	0	0	0	0	0	0	0	0	0	0
3^rd	2000	1	0	0	0	0	0	0	0	0	0	0	0
		2	0	0	0	0	0	0	0	0	0	0	0
		3	0	0	0	0	0	0	0	0	0	0	0

Legend:

G.I.T– Gastrointestinal tract

R.T – Reproductive tract

0 – Not observed alteration

A – Observed alteration

 

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Under the test conditions, the test substance Lithium Tetrafluoroborate, when administered by oral route in female rats, cause deaths, for every step taken at the dose levels of 2000 mg kg-1 of body weight. In clinical examinations, the tested animals did show systemic signs of toxicity. In macroscopic evaluations no alterations were observed during the necropsies. Based on the flow chart with the starting dose of 300 mg kg-1 of body weight, the test substance was classified as category 4, according to the GHS (Globally Harmonized Classification System for Chemical Substances and Mixtures). The oral LD50 value of test substance Lithium Tetrafluoroborate, for female rats, was estimated to be 500 mg kg-1 of body weight.