Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye 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:
partly limited documentation, only 85 mg applied

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
application amount (50 µl, ca 85 mg)
Principles of method if other than guideline:
BASF test
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:
- Name of test material (as cited in study report): Litholechtscharlach 4290, C.I.Pigmentred 48:4, Monoazofarbstoff.
- Analytical purity: 100 %
- 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.
Specific details on test material used for the study:
- Physical state: solid
- Name of test material (as cited in study report): Litholechtscharlach 4290, C.I.Pigmentred 48:4, Monoazofarbstoff.
- Analytical purity: 100 %

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler (Breeder)
- Weight at study initiation: 2.68 kg (female), 3.22 kg (male)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: talcum (amorph) into the other eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL
- Concentration: undiluted
Duration of treatment / exposure:
Treatment was once. The eye was left unwashed, which could be critical for solids which thus remained on the cornea for several days, causing mechanical damage, which would probably be less severe if it had been washed out after 1 day.
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
1 female, 1 male
Details on study design:
SCORES
Descriptive scores of the raw data have been converted to Draize numerical scores

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met