Cobalt, borate neodecanoate complexes

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011-10-19 to 2011-10-22

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

2002-04-24

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Cobalt, borate neodecanoate complexes

EC Number:

270-601-2

EC Name:

Cobalt, borate neodecanoate complexes

Cas Number:

68457-13-6

Molecular formula:

Cobalt, borate neodecanoate complexes

IUPAC Name:

Cobalt, borate neodecanoate complexes

Details on test material:

- Name of test material (as cited in study report): Cobalt Boro Neodecanoate- Physical state: sticky blue resin- Stability under test conditions: stable under the conditions of the test protocol (private communication sponsor)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: Kuiper Rabbitry, Gary, Indiana- Age at study initiation: approximately ten to twelve weeks old- Weight at study initiation: 2.42 to 2.67 kg- Housing: the rabbits were individually housed in stainless steel cages.- Diet (ad libitum): Purina Laboratory Rabbit Chow- Water (ad libitum): water- Acclimation period: at least five days prior to study initiationThe rabbits were maintained according to the recommendations contained in the National Academy Press 1996: "Guide for the Care and Use of Laboratory Animals".All animals used in this study were considered to be in good health at study initiation.ENVIRONMENTAL CONDITIONS- Temperature: 20 ± 3°C- Humidity: 30 - 70%- Photoperiod (hrs dark / hrs light): 12/12

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 aliquot of the test material, which was slightly warmed (34°C) in a water batch to facilitate application, was applied.

Duration of treatment / exposure:

4 hours

Observation period:

approximately 30 minutes after patches were removed, and 24, 48 and 72 and 168 hours after treatment

Number of animals:

3 female rabbits

Details on study design:

TEST SITE- Area of exposure and type of wrap if used: the day before study initiation, electric clippers were used to remove the hair from the left side of the trunk, from the midline of the back to the abdomen. The following day an aliquot of the test material, which was slightly warmed (34°C) in a water batch to facilitate application, was then applied to an area approximately 6 square centimeters on the side of the test animal. The application site is located approximately 5 - 7 centimeters down from the backbone. The test substance was then covered with a 2.5 cm^2 - 2 layer gauze patch held in place with non-irritating Kendall Curity Standard Porous Tape and the patch was then covered with a semi-occlusive plastic overwrap secured in place with Kendall Curity Standard Porous Tape for the duration of the exposure period. REMOVAL OF TEST SUBSTANCE- Washing (if done): excess material was removed from the site- Time after start of exposure: at the end of the 4 hour contact periodSCORING SYSTEM: the site was observed and scored according to the Draize scaleOther adverse changes at the skin sites will be recorded if present.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

There were minimal irritation reactions (very slight erythema - grade 1) in two of the test subjects which cleared by the 168 hour observation.

Other effects:

There was slight mechanical damage to the skin when samples were removed, as the sticky material had adhered to the skin surface.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material is non-irritating to the skin of rabbits.
According to the EC Regulation No. 1272/2008 and subsequent regulations, cobalt borate neodecanoate is not classified as a skin irritant.