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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
Minor deviations without an effect on the results: - According to the guideline, the relative humidity in the animal room should be 30 - 70 %. In this study the humidity was slightly higher (55% +/- 25 %). - According to the guideline, approx. 24 h before the test the fur should be removed by clipping or shaving. In this study it was not stated when the fur was removed. - According to the guideline, justification for choice of vehicle must be stated. In the report it was not stated, if the test substance (solid) was moistened with water or a vehicle. - According to the guideline, the age, the weight at the conclusion of the test and the source of the animals should be stated. This information was missing in the report. - According to the guideline a narrative description of the degree and nature of irritation observed must be included in the report. This was missing in this report. Only the scoring of erythema and oedema were stated.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992-07-17
Deviations:
yes
Remarks:
, see "rational for reliability"
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Physical state: Not stated, but it is common knowledge that this test substance is a solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Authorised supplier
- Weight at study initiation: animal #1: 2652 g; animal #2: 2501 g; animal #3: 2654 g
- Housing: Individual stainless steel cages, brand Tecniplast
- Diet: Daily dose of 150 g of special diet for experimental rabbits, provided by an authorised provider
- Drink (ad libitum): Automatic, treated and filtered at 5 µm
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ° C (+/- 2°C)
- Relative humidity: 55 % (+/- 25 %)
- Air: Renewed 15 times per hour and prefiltered at 5 µm
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: No data: "In case of solid samples, 0.5 g are applied humidifying sufficiently with water (or appropriate fluid) to ensure a good contact with skin."
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g are applied humidifying sufficiently with water (or appropriate fluid) to ensure a good contact with skin.

Duration of treatment / exposure:
maximum time of exposure was 4 hours
Observation period:
1 hour, 24 hours, 48 hours, 72 hours, 7 days and 14 days after removal of the bandages
Number of animals:
3 male rabbits
Details on study design:
TEST SITE
- Area of exposure: The rabbits were shaved at the back retro-scapular area close to the vertebral column, in a 20 cm long, 13 cm wide rectangle. Once the rabbit has been shaved, the sample was applied directly on the skin, on a surface approx. 6 cm^2.
- Type of wrap if used: The test site was covered with a bandage, it was held with plaster and covered with a hypoallergenic plaster bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The studied sample was softly removed with water or appropriate solvent.
- Time after start of exposure:Once the period of exposure was over.

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
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:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
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:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
All skin effects observed were reversed by day 14.
1-hour observation in rabbits:
Animal #1:
Erythema: Score 1 (very slight (hardly perceptible)
Oededma: Score 0 (none)
Animal #2:
Erythema: Score 1 (very slight (hardly perceptible)
Oededma: Score 0 (none)
Animal #3:
Erythema: Score 1 (very slight (hardly perceptible)
Oededma: Score 0 (none)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Given that a mean value of 2 or higher was not observed in any of the tested animals, it can be concluded that the sample submitted "VERDE-D7 (B2240) ((Hematite chromium green black) does not generate skin irritation.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as skin irritant.