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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012-03-27 to 2012-04-03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 2002-04-24
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): cobalt dinitrate
- Physical state: brown crystals
- Stability of test item: stable under storage conditions
- Storage condition of test material: closed container, away from light, room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kuiper Rabbitry, Gary, Indiana
- Age at study initiation: approximately ten to twelve weeks old
- Weight at study initiation: 2.79 to 2.91 kg
- Housing: individually housed in stainless steel cages
- Diet (ad libitum): Purina Laboratory Rabbit Chow
- Water (ad libitum)
- Acclimation period: at least five days

The rabbits were maintained according to the recommendations contained in the National Academy Press 1996: "Guide for the Care and Use of Laboratory Animals".

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:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g. aliquot of the test material was slightly moistened with the vehicle
Duration of treatment / exposure:
Initial animal: 3 minutes, 1 hour and 4 hours
Confirmatory animals: 4 hours
Observation period:
30 minutes, 24, 48, 72 and 168 hours after removal of the test substance
Number of animals:
3 male rabbits
Details on study design:
INITIAL AND CONFIRMATORY TEST
One animal was screened by applying the test substance for a 3 minute and 1 hour topical exposure. No irritation was observed in either exposure; therefore the four hour exposure was conducted.

TEST SITE
- Area of exposure/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 was slightly moistened with the vehicle and 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 cm² - 2 layer gauze patch held in place with non-irritating Kendall Curity Standard Porous Tape and the patch was then covered with a occlusive plastic overwrap secured in place with Kendall Curity Standard Porous Tape for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: at the end of the 4 hour contact period

SCORING SYSTEM: according to the Draize scale
Other adverse changes at the skin will be reocrded if present

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
There were mild irritation reactions in all three the test subjects which cleared by the 168 hour observation.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is not irritating to the skin.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not irritating to the skin.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as skin irritant.