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Diss Factsheets

Administrative data

Endpoint:
eye irritation
Remarks:
other: in-vitro
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP-guideline study - however the conclusion of the test ("A mean IVIS of -0.3690 was calculated, corresponding to a classification as not eye irritant.") is not correct. The BCOP test is an in-vitro test method that can be used to classifiy substances as "ocular corrosives and severe irritants". For identifying non-severe irritants and non-irritants, in-vivo testing needs to take into account.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD 437 dated Sept. 2009
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Kaiser-Friedrich-Straße 7, 55113 Mainz, Germany

Test material

Constituent 1
Chemical structure
Reference substance name:
Aluminum cobalt oxide
EC Number:
235-762-5
EC Name:
Aluminum cobalt oxide
Cas Number:
12672-27-4
Molecular formula:
Co2Al2.6O4.8 corresponding to two crystalline phases: CoAl2O4 (35%) and Al2Co2O5 (65%)
IUPAC Name:
dialuminum; cobalt(2+); oxygen(2-)
Details on test material:
- Name of test material (as cited in study report): cobalt aluminium oxide
- Physical state: dark blue powder
- Analytical purity: 99%
- Batch No.: EH 110006/1
- Expiration date of the batch: June 2013
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
other: in-vitro assay
Strain:
other: in-vitro assay

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: not applicable
Duration of treatment / exposure:
not applicable
Observation period (in vivo):
not applicable
Number of animals or in vitro replicates:
not applicable

Results and discussion

Any other information on results incl. tables

Absorption and opacity values

 

Parameter

Negative control

Test substance

Positive control

Absorption before exposition

0.1399

0.1525

0.1113

0.1509

0.1801

0.1504

0.1842

0.1646

0.2069

Absorption after exposition

0.2200

0.2820

0.1816

0.1851

0.2362

0.2346

1.5811

1.8850

1.5742

Opacity before exposition

1.3799

1.4208

1.2922

1.4154

1.5139

1.4256

1.5282

1.4607

1.6101

Opacity after exposition

1.6594

1.9144

1.5192

1.5313

1.7228

1.7163

38.1132

76.7361

37.5155

Opacity difference

0.2795

0.4936

0.2270

0.1159

0.2089

0.2907

36.5850

75.2754

35.9054

Mean opacity difference of the negative control is 0.3334.

 

 

Optical density at 490 nm

 

Negative control

Test substance

Positive control

Meas.

0.0129

0.0140

0.0128

0.0126

0.0145

0.0028

0.4596

0.6091

0.7609

Corr (x5)*

0.0643

0.0698

0.0639

0.0632

0.0724

0.0142

2.2979

3.0456

3.8044

Mean

0.0660

-

Corr. – Mean negative control

-0.0028

0.0064

-0.0158

2.2319

2.9796

3.7384

*In order to correct the path length, a factor of 5 was taken into account when calculating the IVIS.

 

IVIS values

IVIS was calculated using the values in tables 1 and 2 and the equation stated before:

 

Test group

Mean IVIS

Relative standard deviation IVIS

Negative control 0.9% NaCl

1.320

14.4%

Test substance

-0.3690

-110.3%

Positive control 20% Imidazole

93.6710

26.7%

 

Applicant's summary and conclusion

Interpretation of results:
other: non corrosive
Remarks:
Criteria used for interpretation of results: EU