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:
comparable to guideline study with acceptable restrictions
Remarks:
acceptable restrictions, mostly due to reduced reporting in times before GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Principles of method if other than guideline:
Skin irritation was tested using an internal standard method (BASF test). White Vienna rabbits were used. Usually, animals were treated for 1, 5 and 15 minutes and for 20 hours using occlusive conditions. An application site of 2.5 X 2.5 cm was covered with the liquid or powdered and moistened test substance. Exposure of 1, 5 and 15 minutes was not done in this experiment
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Manganese, 4-[(5-chloro-4-methyl-2-sulfophenyl)azo]-3-hydroxy-2-naphthalenecarboxylic acid complex
EC Number:
226-102-7
EC Name:
Manganese, 4-[(5-chloro-4-methyl-2-sulfophenyl)azo]-3-hydroxy-2-naphthalenecarboxylic acid complex
Cas Number:
5280-66-0
Molecular formula:
C18H11N2O6SClMn
IUPAC Name:
Manganese, 4-[(5-chloro-4-methyl-2-sulfophenyl)azo]-3-hydroxy-2-naphthalenecarboxylic acid complex
Test material form:
solid: nanoform
Details on test material:
- Physical state: solid
- Name of test material (as cited in study report): Litholechtscharlach 4300, C.I.Pigmentred 48:4, Monoazofarbstoff.
- Analytical purity: 100%

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.
Specific details on test material used for the study:
- Physical state: solid
- Name of test material (as cited in study report): Litholechtscharlach 4300, C.I.Pigmentred 48:4, Monoazofarbstoff.
- Analytical purity: 100%

Test animals

Species:
rabbit
Details on test animals or test system and environmental conditions:
TEST ANIMALS
-Source: Breeder
- Weight at study initiation: female: 3.06 kg, male: 3.23 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Concentration: 50 % aqueous solution, creamy
Duration of treatment / exposure:
20 hour(s)
Observation period:
8 days
Number of animals:
1 female, 1 male
Details on study design:
Since irritation data are recommended for a 4 h skin exposition, results of the available 20 h exposition will serve as approximation.

TEST SITE
- Area of exposure: dorsal
- % coverage: 2.5 x 2.5 cm
- Type of wrap if used: cotton lobe

SCORING SYSTEM: Descriptive scores of the raw data have been converted to Draize numerical scores.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
other: red compound residues
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not determinable
Other effects:
Red substance residues after 24 h. No abnormality and no red substance residues detected after 8 d.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met