Registration Dossier

Administrative data

Endpoint:
skin sensitisation, other
Remarks:
in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009-09-23 to 2009-10-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study reliable without restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
, adopted 2002-04-24
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
signed 2009-04-06
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tricobalt Tetraoxide (CoRC Study EFF06)
- Chemical name: Tricobalt Tetraoxide
- Molecular formula: Co3O4
- Physical state: powder; black colour, odourless
- Analytical purity: 99.5 %
- Cobalt content: Cobalt, approximately 73.5 %
- Batch No.: Lot# 3710770
- Expiration date of the batch: 2017-03-14
- Storage condition of test material: At room temperature
- Relative density: 6.07
No further information on the test material was stated.

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann, 33178 Borchen, Germany
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: 17 - 22 g
- Housing: Full barrier in an air-conditioned room; The animals were kept in groups of 5 animals in IVC cages, type II L, polysulphone cages on Altromin saw fibre bedding (lot no. 060609, preliminary test; 040509, main test)
- Diet (ad libitum): Altromin 1324 maintenance diet for rats and mice (lot no. 0654)
- Water (ad libitum): Tap water, sulphur acidified to a pH value of approx. 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals).
- Acclimation period: At least five days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3°C
- Relative humidity: 55 +/- 10 %
- Air changes: At least 10 X / hour
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated.

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: see Remark
Remarks:
None of the three tested concentrations of the test item reached the stimulation index of 3: The stimulation index at a concentration of 12.5 % was 0.9. The stimulation index at a concentration of 25 % was 1.0. The stimulation index at a concentration of 50 % was 0.8. The EC3 value (derived by linear interpolation) could not be calculated as the stimulation indices of all concentrations were below 3.
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Please see "Attached background material"

Any other information on results incl. tables

Residual test-item was observed on day 2 at the site of application in concentration group 25 % and 50%. On day 3 of application, residual test-item was observed at the site of application in all the three treated groups i.e. 12.5 %, 25 % and 50%.

All animals survived throughout the test period without showing any clinical signs.

All animals showed the expected weight development, which includes a weight loss of up to 2 g throughout the study.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item tricobalt tetraoxide (CoRC Study EFF06) is expected to have no sensitising properties and therefore, should not be regarded as a dermal sensitiser.
According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is not classified as skin sensitiser.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as skin sensitiser.