dilithium trimanganese nickel octoxide

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:

2022

Report date:

2022

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

impurity 1

Reference substance name:

Dipotassium oxide

EC Number:

235-227-6

EC Name:

Dipotassium oxide

Cas Number:

12136-45-7

Molecular formula:

K2O

IUPAC Name:

Potassium oxide

impurity 2

Reference substance name:

Disodium oxide

EC Number:

215-208-9

EC Name:

Disodium oxide

Cas Number:

1313-59-3

Molecular formula:

Na2O

IUPAC Name:

sodium oxide

impurity 3

Reference substance name:

Lithium sulphate

EC Number:

233-820-4

EC Name:

Lithium sulphate

Cas Number:

10377-48-7

Molecular formula:

H2O4S.2Li

IUPAC Name:

dilithium sulfate

impurity 4

Reference substance name:

Nickel monoxide

EC Number:

215-215-7

EC Name:

Nickel monoxide

Cas Number:

1313-99-1

Molecular formula:

NiO

IUPAC Name:

Nickel (II) oxide

impurity 5

Reference substance name:

dilithium manganese nickel tetraoxide

Cas Number:

128975-24-6

Molecular formula:

Li2MnNiO4

IUPAC Name:

dilithium manganese nickel tetraoxide

Constituent 1

Reference substance name:

dilithium trimanganese nickel octaoxide

EC Number:

663-306-9

Cas Number:

12031-75-3

Molecular formula:

Li2Mn3NiO8

IUPAC Name:

dilithium trimanganese nickel octaoxide

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Batch no: 2021083735

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Species and strain: Han: WIST rats
Source: TOXI COOP ZRT.
Cserkesz u. 90. 1103 Budapest, Hungary
Hygienic level at arrival: SPF
Hygienic level during the study: good conventional
Justification of strain: The Wistar rats as a rodent is one of the standard species of acute toxicity studies
Number of animals: 3 animals/group
Sex: Female, nulliparous and non-pregnant animals
Age of animals: Young adult rat, 8-9 weeks old in first and second step
Body weight range
at starting (first step): 178 - 180 g
Body weight range
at starting (second step): 178 - 185 g
Acclimatization time: 12 days in first step and 13 days in second step

Animal health: Only healthy animals were used for the study. Health status was certified by the study director.
Room: 13/3
Housing: Group caging (3 animals/cage)
Cage type: Type III polypropylene/polycarbonate.
Bedding: Laboratory bedding.
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 22 ± 3 °C
Relative humidity: 30 - 70 %
Ventilation: above 10 air exchanges/hour by central air-condition system.
The temperature and relative humidity parameters were recorded daily during the study.

Animals received ssniff® SM R/M-Z+H complete diet for rats and mice produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany and tap water from municipal supply, as for human consumption from bottle ad libitum.
The diet and drinking water are periodically analysed and are considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study. Copies of the relevant Certificates of Analysis are maintained in Toxi-Coop Zrt.’s archive.
Contents of ssniff® SM R/M-Z+H complete diet are presented in Appendix V.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Helianthi annui oleum raffinatum

Doses:

The starting dose was selected on the basis of the available information outlined from the monitor. The estimated LD50 values of the metals as follows: 30057 mg/kg bw for LiCl, 19531 mg/kg bw for NiCl2 and 19230 mg/kg bw for MnCl2.
The acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. No animals died in first step, so further three female rats were treated with the same dose. No animals died in second step, too, so the test was finished, because the stopping criteria of Annex 2d of OECD Guideline No. 423 (presented in Appendix VII) was met.

No. of animals per sex per dose:

3 animals/group

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 - < 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No death occurred at 2000 mg/kg bw single oral dose of LNMO cathode material. All female rats in step 1 and step 2 survived until the end of the 14-day observation period.

Body weight:

lower than 10% body weight loss

Gross pathology:

All animals treated with 2000 mg/kg bw dose survived until the scheduled necropsy on Day 15.
No pathological changes were found related to the effect of the test item during the macroscopic examination of animals treated with 2000 mg/kg bw dose.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The test item was ranked into classes of Globally Harmonized Classification System (GHS) described in the OECD Guideline No. 423 : GHS category 5: between 2000 and 5000 mg/kg bw LD50

Executive summary:

General information:

The starting dose was selected on the basis of the available information outlined from the monitor. The estimated LD50 values of the metals as follows: 30057 mg/kg bw for LiCl, 19531 mg/kg bw for NiCl2 and 19230 mg/kg bw for MnCl2.

The acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. No animals died in first step, so further three female rats were treated with the same dose. No animals died in second step, too, so the test was finished, because the stopping criteria of Annex 2d of OECD Guideline No. 423 (presented in Appendix VII) was met.

Animals were weighed, observed for lethality and toxic symptoms for 14 days after the treatment. Gross pathological examination was carried on the 15th day after the treatment.

Lethality, Clinical symptoms and Body weight:

No lethality was noted at single oral dose of 2000 mg/kg bw.

In each of first and second step, no clinical symptoms were observed on the day of the treatment and during the 14-day observation period, the general state and behaviour of experimental animals were normal.

The body weight development was undisturbed in all animals.

Gross pathology:

All organs of the animals treated with 2000 mg/kg bw proved to be free of treatment related gross pathological changes.

Evaluation:

The test item was ranked into classes of Globally Harmonized Classification System (GHS) described in the OECD Guideline No. 423 : GHS category 5: between 2000 and 5000 mg/kg bw LD50