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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:
2012-06-22 to 2012-06-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP guideline study reliable without restrictions The following deviations from the guideline OECD 404 (2002) occured, but they had no effect on the results of the study: - the animals were observed 30 minutes after the removal of the test item instead of 60 minutes after test item removal - the animals were not observed for systemic adverse effects, but only for the skin irritation listed in the Draize scoring system

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:
2002-04-24
Deviations:
yes
Remarks:
please refer to "Rationale for reliability incl. deficiencies" above
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Cobalt borate propionate (C40B.5-PTL)
- Physical state: purple powder
- 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: 2.67 to 2.82 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 initiation

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3°C
- Relative 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 distilled water

Duration of treatment / exposure:
4 hours
Observation period:
30 minutes, 24, 48 and 72 hours after removal of the test substance
Number of animals:
3 male rabbits
Details on study design:
INITIAL 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. Following the 4 hour exposure of the one animal, two additional animals were tested for four hours.

TEST SITE
- Area of exposure: 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 with the vehicle was 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.
- Type of wrap if used: the test substance was 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 semi-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, excess material was removed from the site; the site being observed and scored.

SCORING SYSTEM: according to the Draize scale
Other adverse changes at the skin sites will be recorded 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:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
There were mild irritation reactions (grade 1 - very slight erythema (barely perceptible)) in two of the test subjects at the 30 minute observation which cleared by the 24 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 item is not a skin irritant.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as skin irritant.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as skin irritant