Registration Dossier
Registration Dossier
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EC number: 277-552-6 | CAS number: 73612-29-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- eyes were not washed out
- GLP compliance:
- yes
Test material
- Reference substance name:
- Strontium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
- EC Number:
- 277-552-6
- EC Name:
- Strontium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
- Cas Number:
- 73612-29-0
- Molecular formula:
- C18H14N2O6S.Sr
- IUPAC Name:
- strontium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate
- Test material form:
- solid: nanoform
- Details on test material:
- 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.
Constituent 1
- Specific details on test material used for the study:
- - Physical state: powder, red
- Analytical purity: the test substance has not been fully analytically characterized
- Lot/batch No.: CS-485
- Stability under test conditions: the stability has not been determined analytically
- Storage condition of test material: room temperature
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany
- Age at study initiation: young adult
- Mean weight at study initiation: Males: 3.6 kg, females: 3.8 kg
- Clipping of the fur: at least 15h
- Housing: individually
- Diet: Kliba-Labordiaet 341, 4 mm, Klingentalmuehle AG, Kaiseraugst, Switzerland; ad libitum
- Water: tap water; ad libitum
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 h/12 h
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: other untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL bulk volume ( (about 58 mg of the comminuted test substance)
- Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 1 male, 2 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: the test substance was not washed out
READINGS: 1h, 24h, 48h, 72h after application
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 #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 1 and # 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- Discharge after one hour
Any other information on results incl. tables
Exposition: Single application to the conjunctival sac of the eyelid; the substance is not washed out |
||||||
Animal |
Reading |
Cornea |
Iris |
Conjunctiva |
Additional findings |
|
|
|
Opacity |
|
Redness |
Chemosis |
|
1 |
1 h |
0 |
0 |
1 |
0 |
- |
2 |
1 h |
0 |
0 |
1 |
0 |
- |
3 |
1 h |
0 |
0 |
1 |
0 |
- |
1 |
24 h |
0 |
0 |
0 |
0 |
- |
2 |
24 h |
0 |
0 |
2 |
0 |
- |
3 |
24 h |
0 |
0 |
0 |
0 |
- |
1 |
48 h |
0 |
0 |
0 |
0 |
- |
2 |
48 h |
0 |
0 |
1 |
0 |
- |
3 |
48 h |
0 |
0 |
0 |
0 |
- |
1 |
72 h |
0 |
0 |
0 |
0 |
- |
2 |
72 h |
0 |
0 |
0 |
0 |
- |
3 |
72 h |
0 |
0 |
0 |
0 |
- |
mean animal 1 |
24 - 72 h |
0.00 |
0.00 |
0.00 |
0.00 |
|
mean animal 2 |
24 - 72 h |
0.00 |
0.00 |
1.00 |
0.00 |
|
mean animal 3 |
24 - 72 h |
0.00 |
0.00 |
0.00 |
0.00 |
|
mean total |
24 - 72 h |
0.00 |
0.00 |
0.33 |
0.00 |
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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