Tricobalt dicitrate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 Mar - 09 Apr 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

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)

Remarks:

Ministère de L'Economie de L'Industrie et de L'emploi

Test material

Test material information

Constituent 1

Reference substance name:

Tricobalt dicitrate

EC Number:

212-751-3

EC Name:

Tricobalt dicitrate

Cas Number:

866-81-9

Molecular formula:

C6H8O7.3/2Co

IUPAC Name:

tricobalt dicitrate

Details on test material:

- Name of test material (as cited in study report): Cobalt Citrate
- CAS No.: 866-81-9
- Data received: 23 March 2010
- Physical state / Appearance: pink powder
- Analytical purity: 99%
- Lot/batch No.: 10142709
- Expiration date of the lot/batch: 01 April 2011
- Storage condition of test material: Room temperature

Test animals

Species:

rabbit

Strain:

other: albino New Zealand

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste - F40260 Linxe)
- Age at study initiation: 11 or 12 weeks
- Weight at study initiation: between 2.43 kg and 2.68 kg
- Housing: individual box with suitable environmental enrichment
- Diet (e.g. ad libitum): SDS - C15 ad libitum
- Water (e.g. ad libitum): tap-water (from public distribution system - microbiological and chemical analyses of the water were carried out once every six months) ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light):12 hours light (07.00 to 19.00) and 12 hours darkness

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: on the opposite flank an untreated area served as the control

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours (as no tissue destruction was noted after a treatment during 3 minutes and 1 hour)

Observation period:

3 days: skin reactions were evaluated 1 hour and then 24, 48 and 72 hours after removal of the patch

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: back and flank
- % coverage: 6 cm2
- Type of wrap if used: strip of surgical adhesive tape under semi-occlusive dressing


REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed with distilled water after the removal of the patch
- Time after start of exposure: 4 hours


SCORING SYSTEM: Grading scales 0 - 4 (erythema and eschar formation ; oedema)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Any other information on results incl. tables

No cutaneous reactions (erythema and oedema) were observed on the treated area, whatever the examination time was (i.e. 1 hour, 24, 48 and 72 hours after the patch removal). The primary skin irritation index for cobalt citrate is 0.0.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information