Lithium Nickel Cobalt Aluminium Oxide

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:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Remarks:

testing lab.

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Nickel

EC Number:

231-111-4

EC Name:

Nickel

Cas Number:

7440-02-0

Molecular formula:

Ni

IUPAC Name:

nickel

Constituent 2

Reference substance name:

Cobalt

EC Number:

231-158-0

EC Name:

Cobalt

Cas Number:

7440-48-4

Molecular formula:

Co

IUPAC Name:

cobalt(2+)

Constituent 3

Reference substance name:

Lithium

EC Number:

231-102-5

EC Name:

Lithium

Cas Number:

7439-93-2

Molecular formula:

Li

IUPAC Name:

lithium

Constituent 4

Reference substance name:

Aluminium

EC Number:

231-072-3

EC Name:

Aluminium

Cas Number:

7429-90-5

Molecular formula:

Al

IUPAC Name:

aluminum

Test material form:

solid: particulate/powder

Details on test material:

Composition represents the lowest and highest possible concentration of each individual constituent in NCA (estimated by Monte Carlo simulation, taking into account the following ranges of variability:
Sum of of Ni+Co+Al = approx. 1
Li =0.9-1.3
Ni: 0.75-0.99
Co: 0.01-0.2
Al: 0.01-0.2
A more detailed composition can be provided by the data holder, but is not defined in this record as this represents sensitive business information that cannot be shared with co-registrants. The composition, however, fits into the agrees Substance Identity Profile.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: Young adult animals (male animals approx. 8 weeks, female animals approx. 12 weeks)
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight, actual weights)
- Housing: Makrolon cage, type III, Single housing
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany; ad libitum
- Water: Tap water ad libitum; ad libitum
- Acclimation period: at least 5 days before the beginning of the experimental phase

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

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

other: 0.5% solution of CMC (sodium carboxymethylcellulose) in deionized water

Details on dermal exposure:

TEST SITE
- Area of exposure: 40 cm²
- % coverage: 10
- Type of wrap if used: air-permeable dressing (4 layers of absorbent gauze (Ph. Eur. supplied by Lohmann GmbH & Co., KG) and stretch bandage (Fixomull® Stretch (adhesive fleece) supplied by Beiersdorf AG)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Afterwards removal of the semi-occlusive dressing, rinsing of the application site with warm water
- Time after start of exposure: 24 h

TEST ITEM PREPARATION
- Test item preparation and homogenization until end of each application period: The test item preparation was produced for each test group shortly before application by stirring with a high speed homogenizer and a magnetic stirrer. Additionally, the homogeneity of the test item preparation during application was ensured by stirring with a magnetic stirrer.
- Vehicle: 0.5% solution of CMC (sodium carboxymethylcellulose, Dow Wolff Cellulosics GmbH) in deionized water
- Reason for the selection of the vehicle: A good homogeneity in water could not be guaranteed, because the test item preparation was a suspension. Therefore, a 0.5% solution of CMC in deionized water was applied.
- Form of application: Suspension

Duration of exposure:

24 h

Doses:

1000 and 2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, mortality, pathology

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no mortality occured in any group

Mortality:

No mortality occurred.

Clinical signs:

other: No systemic clinical signs were observed. Due to the black discoloration of the application area erythema could not be determined in all male and female animals of the 2000 mg/kg bw dose group on study day 1 and in the males of the 1000 mg/kg bw dose gro

Gross pathology:

No macroscopic pathologic abnormalities were noted in all animals examined on the last day of observation.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No mortality was noted in any of the test groups (up to 2000 mg/kg bw). No systemic clinical signs or macroscopic pathologic abnormalities were observed.
The observed stagnation or marginal decrease of body weight was considered to be unspecific.