Cobalt Lithium Manganese Nickel Oxide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 May 2007 to 26 May 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to valid guidelines and the study was conducted under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

480-390-0

EC Name:

-

Cas Number:

182442-95-1

Molecular formula:

LiCoNiMnO2 with the stoechiometry of Co+Ni+Mn equal to 1 and the ranges of the elements approximately as: Li: >0.90 - <1.20 Co: >0.0 - <0.50 Ni: >0.20 - <0.98 Mn: >0.0 - <0.50 O: 2

IUPAC Name:

Cobalt Lithium Manganese Nickel Oxide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Cellcore MX
- Physical state: solid
- Appearance: black powder
- Storage condition of test material: room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 12 - 20 weeks old
- Weight at study initiation: 2.0 - 3.5 kg
- Housing: individually in suspended cages
- Diet: ad libitum Certified Rabbit Diet
- Water: ad libitum access to mains drinking water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 – 23 °C
- Humidity (%): 30 – 70 % (relative)
- Air changes (per hr): at least 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light (06:00 to 18:00)

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Remarks:

The test material was moistened with distilled water.

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): the test material was used as supplied; it was moistened with 0.5 mL of distilled water prior to skin application.

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure and type of wrap used: on the day before the test, the rabbits were clipped free of fur from the dorsal/flank area using veterinary clippers. The moistened test material was introduced under a 2.5 x 2.5 cm cotton gauze patch and placed in position on the shorn skin on the back of each animal. The patch was secured in position with a strip of surgical adhesive tape. The trunk of each animal was then wrapped in an elastic corset.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the corset and patch were removed and residual test material was removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 hours after application of the test material.

SCORING SYSTEM: Approximately 1, 24, 48 and 72 hours following removal of the patches, the test sites were examined for evidence of primary skin reaction according to the Draize scale.
Any other skin reactions, if present, were also recorded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Remarks on result:

other: no indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Remarks on result:

other: no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Remarks on result:

other: noindication of irritation

Irritant / corrosive response data:

A single 4-hour, semi-occluded application of the test material to the intact skin of 3 rabbits produced an isolated incident of very slight erythema one hour after patch removal at one treated site. Two treated skin sites appeared normal throughout the study and the remaining skin site appeared normal at the 24-hour observation.

Any other information on results incl. tables

Table 1: Individual Skin Reactions

Skin reaction	Observation time (hours)	Individual scores			Total
		1M	2M	3M
Erythema/ eschar formation	1	1	0	0	(1)
	24	0	0	0	0
	48	0	0	0	(0)
	72	0	0	0	0
Oedema formation	1	0	0	0	(0)
	24	0	0	0	0
	48	0	0	0	(0)
	72	0	0	0	0

( ) = values not used for calculation of overall irritation score

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study the test material was determined to be a non-irritant to the skin. No corrosive effects were noted.

Executive summary:

The irritancy potential of the test material was investigated in the New Zealand White rabbit in a study which was conducted under GLP conditions and in accordance with the standardised guidelines OECD 404 and EU Method B.4.

A single 4-hour, semi-occluded application of test material was made to the intact skin of three male rabbits. Approximately 1, 24, 48 and 72 hours following removal of the patches, the test sites were examined for evidence of primary skin reaction according to the Draize scale and the primary irritation index calculated.

The application of the test material produced an isolated incident of very slight erythema at one skin site when examined 1 hour after patch removal. Two treated skin sites appeared normal throughout the study and the remaining treated skin site appeared normal at the 24-hour observation.

The test material produced a primary irritation index of 0 and was classified as a non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted. Therefore in accordance with EU criteria, the test material requires no classification.