lithium nickel dioxide

Endpoint summary

Description of key information

LD50, oral, rat > 2000 mg/kg bw (OECD 423, BASF SE, 2021)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21.Oct.2020 - 19.Feb.2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

December 17, 2001

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Commission Regulation (EC) No 440/2008 of 30 May 2008

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

December 2002

Qualifier:

according to guideline

Guideline:

other: Japan MAFF Testing Guideline of 12 Nousan No. 8147, November 24, 2000 as this in line with OECD 423.

GLP compliance:

yes (incl. QA statement)

Remarks:

Incl. GLP certificate from the competent authority

Test type:

acute toxic class method

Limit test:

no

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Batch number of test material: 8800315
- Purity: Approx. 99.8 /100 g
- Water content: 0.1 g/100 g

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Expiry date: August 12, 2021
- Storage stability: The stability under storage conditions over the study period was guaranteed by the sponsor
- Homogeneity: The test item was homogeneous by visual inspection.

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item was prepared and homogenized in corn oil for each test group shortly before administration by stirring with a magnetic stirrer.
- Final concentration of a dissolved solid, stock liquid or gel:
For a dose of 300 mg/kg bw: 6 g/100 ml
For a dose of 2000 mg/kg bw: 40 g/100 ml

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Young adult animals (female animals approx. 10 – 11 weeks)
- Weight at study initiation: Animals were of comparable weight (± 20% of the mean weight; mean group weights on day 0: 198.7 - 193.3 g)
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration
- Housing: Single housing in Makrolon cages, type III. Bedding was H 15005-29; (Ssniff Spezialdiäten GmbH) with wooden gnawing blocks
- Diet: LASQCdiet Rod16, HiHyg, LASvendi (Altromin, Germany) ad libitum
- Water: Tap water ad libitum
- Acclimation period: At least 5 days
- Microbiological status: SPF

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): Approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: At least 5 days before October 27, 2020 To: November 24, 2020

Route of administration:

oral: gavage

Vehicle:

corn oil

Remarks:

Ph.Eur.

Details on oral exposure:

VEHICLE
- Concentration in vehicle: Pure corn oil
- Amount of vehicle (if gavage): 5.0 ml/kg bw
- Justification for choice of vehicle: Good homogeneity in corn oil Ph.Eur.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: By request of the sponsor a starting dose of 300 mg/kg bw was chosen in the first step with 3 female animals.
Because no mortality occurred, a further dose of 2000 mg/kg bw was administered to another group of 3 female animals in the second step.
Because no animal died in this step, a further dose of 2000 mg/kg bw was administered to another group of 3 female animals in the third step

Doses:

300 mg/kg bw 1. Administration
2000 mg/kg bw 1. Administration
2000 mg/kg bw 2. Administration

No. of animals per sex per dose:

3 females

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights were assessed shortly before administration (day 0), weekly thereafter and on the last day of observation. Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter. A check for any dead or moribund animals was made at least once each workday
- Necropsy of survivors performed: yes
- Other examinations performed: Mortality, clinical signs, body weight

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no mortalities in any of the test groups

Clinical signs:

other: No clinical signs were observed in any of the test groups

Gross pathology:

There were no macroscopic pathological findings in any animal sacrificed at the end of the observation period

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study the median lethal dose of the test substance after oral administration was assessed to be greater than 2000 mg/kg bw in rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD0

Value:

>= 2 000 mg/kg bw

Quality of whole database:

GLP guideline study

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In an acute oral toxicity study performed according to the Acute Toxic Class Method (OECD 423), doses of 2000 and 300 mg/kg bw of the test item Lithium nickel dioxide (preparations in corn oil Ph.Eur.) were administered by gavage to three test groups of three fasted Wistar rats each (2000 mg/kg bw in 6 females and 300 mg/kg bw in 3 females) (BASF SE, 2021, 10A0255/20X069).
No Animal of any test group neither died nor showed any clinical signs. The body weight of the animals increased within the normal range throughout the study period. There were no macroscopic pathological findings in any animal sacrificed at the end of the observation period (9 females).
The acute oral LD50 was assessed to be LD50, oral, rat > 2000 mg/kg bw

Justification for classification or non-classification

Based on the findings for acute oral toxicity, i.e. an LD50 above 2000 mg/kg bw in the chosen key study, the substance does not fulfill the criteria laid down in Regulation (EC) No 1272/2008 (CLP Regulation) and a non-classification is warranted.