Calcium divanadium hexaoxide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994-03-29 to 1994-04-03

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Guideline study Minor deviations from the guideline with no effect on the results: - The test substance was not moistened before application in order to ensure good contact with the skin of the animals, as recommended by OECD 404. CaO would have been transformed into Ca(OH)2, if the test substance had been moistened, which would mean that not the actual test substance would have been tested in this case. - The sex, age and weight of the animals are not indicated. - It is not indicated if the test substance was removed after treatment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

, adopted 1992-07-17

Deviations:

yes

Remarks:

see "rationale for reliability"

GLP compliance:

yes (incl. QA statement)

Remarks:

signed 1991-10-21

Test material

Test material information

Constituent 1

Reference substance name:

Calcium oxide

EC Number:

215-138-9

EC Name:

Calcium oxide

Cas Number:

1305-78-8

Molecular formula:

CaO

IUPAC Name:

Calcium oxide

Details on test material:

- Name of test material (as cited in study report): Weißfeinkalk (supplied by: Bundesverband der deutschen Kalkindustrie e.V., Postfach 510550, 50941 Köln)
- Chemical name: Calcium oxide
- Physical state: White powder
- Analytical purity: 93 %
- Expiration date of the batch: "For months if well stored to avoid absorption of moisture and CO2"
- Storage condition of test material: Ambient
No further information on the test material was stated.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kaninchenhof Süstedt, Alter Pohl 8, 27305 Süstedt
- Housing: Individual housing (50 X 45X 40 cm, L X B X H) in a battery of cages, each equipped with a paper roll disposal system.
- Diet (ad libitum): Pellets; Ssniff K-Haltung (Zuchtdiät für Kaninchen) (Ssniff Spezialdiäten GmbH, 59494 Soest/Westfalen)
- Water (ad libitum): drinking water as for human consumption

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Relative humidity: 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of calcium oxide
No further information on the amount/concentration applied was stated.

Duration of treatment / exposure:

4 hours

Observation period:

At 60 min, 24, 48, and 72 hours after patch removal

Number of animals:

3 animals

Details on study design:

TEST SITE
- Area of exposure: 24 h before treatment, fur was removed with electric clippers from an area of roughly 8 x 15 cm on the back of each animal. The skin was examined for abrasions and only animals with healthy, intact skin were used in the test. The test article was applied to the test site (ca. 6 cm^2); an adjacent area of untreated skin served as control.
- Type of wrap if used: Each skin area was covered with a semi-occlusive dressing consisting of Ypsiplast® (Holthaus Medical, Remscheid-Lüttringhausen), which was held in place by non-irritating tape (Elastoplast®, Beiersdorf AG, Hamburg), and Stülpa® (P. Hartmann AG, Heidenheim-Brenz), which enveloped the whole of the animal's trunk.

SCORING SYSTEM: Draize scoring system
No further information on the study design was stated.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Irritant / corrosive response data:

No test article-dependent findings were observed.

Other effects:

No toxic effects were observed.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test article was classified on the basis of the mean skin reactions at 24, 48 and 72 h after patch removal.
According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is not a skin irritant.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not a skin irritant.