Registration Dossier

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Code of Federal Regulations, Title 16, Section 1500.42
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid
Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: W. Ostrop/Meerbusch
- Weight at study initiation: mean weight: 2.1 kg
- Housing: one per cage
- Diet (e.g. ad libitum): "muemmel z" (ssniff/Soest)
- Water (e.g. ad libitum): water ad libitum
- Acclimation period: 4-6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 18
- Humidity (%): 40 (relative humidity)
- Photoperiod (hrs dark / hrs light): according to the day light rhythm

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved intact and damaged skin
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg compound slightly thickened with water
Duration of treatment / exposure:
24 hours
Observation period:
8 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: double layer gauze covered by indifferent impermeable PVC (5x5 cm) foil and elastic bandage (ElastoflexR)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize numerical scores.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
intact and damaged skin
Basis:
mean
Time point:
24 h
Remarks on result:
other: scoring not possible due to the skin coloring by the substance
Irritation parameter:
erythema score
Remarks:
intact and damaged skin
Basis:
mean
Time point:
48 h
Remarks on result:
other: timepoint not evaluated
Irritation parameter:
erythema score
Remarks:
intact and damaged skin
Basis:
mean
Time point:
72 h
Remarks on result:
other: scoring not possible due to the skin coloring by the substance
Irritation parameter:
erythema score
Remarks:
intact and damaged skin
Basis:
mean
Time point:
other: 8 days
Remarks on result:
other: scoring not possible due to the skin coloring by the substance
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
24 h
Score:
2.33
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
48 h
Remarks on result:
other: timepoint not evaluated
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
72 h
Score:
0.83
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
other: 8 days
Score:
0.33
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Remarks:
damaged skin
Basis:
mean
Time point:
24 h
Score:
1.83
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Remarks:
damaged skin
Basis:
mean
Time point:
48 h
Remarks on result:
other: time point not evaluated
Irritation parameter:
edema score
Remarks:
damaged skin
Basis:
mean
Time point:
72 h
Score:
1.17
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Remarks:
damaged skin
Basis:
mean
Time point:
other: 8 days
Score:
0.33
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritant / corrosive response data:
The test article caused edema formation below the threshold of regulatory significance. In two animals, the edema was not fully reversed after 8 days but is expected to have cleared after 14 days. The erythema reactions could not be scored due to coloring effects of the test substance. Erythema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Foi. Cosm. Tox. 13, 355, 1975).

Any other information on results incl. tables

Overview of results:

Animal 1 Animal 2 Animal 3 Animal 4 Animal 5 Animal 6
intact skin
erythema 24 h * * * * * *
72 h * * * * * *
8 days * * * * * *
edema 24 h 3 3 1 2 3 2
72 h 0 1 1 1 1 1
8 days 0 0 0 1 1 0
damaged skin
erythema 24 h * * * * * *
72 h * * * * * *
8 days * * * * * *
edema 24 h 2 2 0 2 3 2
72 h 1 0 0 2 2 2
8 days 1 0 0 0 1 0

* could not be scored due to coloration of the skin from the substance

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The results show that there is no corrosive potential of the substance. However, the substance can not be properly evaluated due to substance residues / coloring. The substance is regarded as slightly irritatin, however below the level of regulatory significance.