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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996-10-08 to 1996-10-11
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Purity and stability were missing - Age and weight at the conclusion of testing of the animals were not stated

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992-07-17
Deviations:
yes
Remarks:
please refer to "Rationale for reliability incl. deficiencies" above
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Cobalt aluminate blue spinel
EC Number:
310-193-6
EC Name:
Cobalt aluminate blue spinel
Cas Number:
1345-16-0
Molecular formula:
Co(x)Al(3-x)O4 1≤x≤1,5
IUPAC Name:
Cobalt aluminium spinel
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): C.I. Pigment Blue 28/ H-21327
- Physical state: blue powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hare Marland, Hewitt, New Jersey
- Age at study initiation: young adult
- Weight at study initiation: 2408 to 2779 grams
- Housing: the rabbits were housed singly in suspended, stainless steel, wire-mesh cages.
- Diet (daily): approximately 125 grams of Purina® Certified High Fiber Rabbit Chow® #5325
- Water (ad libitum, except during the exposure period): water
- Acclimation period: rabbits were quarantined, weighed, and observed for general health for approximately 2 weeks.

ENVIRONMENTAL CONDITIONS
- Temperature: 20°C ± 1°C
- Relative humidity: 50% ± 10%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approximately 0.5 g of the test substance, moistened with deionized water

Duration of treatment / exposure:
approximately 4 hours
Observation period:
approximately 1, 24, 48, and 72 hours after removal of the test substance
Number of animals:
6 male rabbits
Details on study design:
TEST SITE
- Area of exposure and type of wrap if used: on the day prior to treatment, the hair of New Zealand White rabbits was closely shaved to expose the skin from the scapular to the lumbar region of the back. Each rabbit was placed into a stock which had been fitted with a piece of rubber sheeting, approximately 8″ x 18″. The rabbits remained in the stocks throughout the exposure period and during that time did not have access to food or water.
The test substance moistened with the vehicle was applied directly on the test site beneath a 2-inch gauze square that was held in place with non-irritating tape. The rubber sheeting was then wrapped around the animal and secured with clips to retard evaporation and to keep the test substance in contact with the skin without undue pressure. In the absence of visible evidence to the contrary, the test substance was assumed to be stable under the conditions of administration. One other test substance was tested concurrently on a separate, localized test site on these rabbits.

REMOVAL OF TEST SUBSTANCE
- Washing: the rubber sheeting was loosened, and the skin at the corners of the gauze squares was marked with a waterproof pen; wrappings and gauze squares were then removed. The test sites were gently washed with Ivory® soap and warm water to remove excess test substance. The skin was gently patted dry, and the animals were returned to their cages.
- Time after start of exposure: approximately 4 hours after application of the test substance

SCORING SYSTEM: according to the Draize scale
The test sites were evaluated for evidence of dermal effects

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: At the 1 hour observation the compound adhered to the skin, but the test site could be evaluated.
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Throughout the observation period the compound adhered to the skin, but the test site could be evaluated.
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: At the 1 hour observation the compound adhered to the skin, but the test site could be evaluated.
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: At the 1 hour observation the compound adhered to the skin, but the test site could be evaluated.
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: At the 1, 24 and 48-hour observations the compound adhered to the skin, but the test site could be evaluated.
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Throughout the observation period the compound adhered to the skin, but the test site could be evaluated.
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The test substance adhered to the skin of all rabbits; however, the test sites could still be evaluated for irritation. No dermal irritation was observed throughout the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is non-irritating to the skin.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as skin irritant.