Registration Dossier
Registration Dossier
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EC number: 943-210-6 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Remarks:
- In vivo study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 1973
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959) of the US Association of Food and Drug Officials (AFDO)
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- tetrasodium 15-[(Z)-2-{4-[(E)-2-{4-[(E)-2-{2,5-dimethyl-4-[(E)-2-(4-sulfophenyl)diazen-1-yl]phenyl}diazen-1-yl]-2-sulfophenyl}ethenyl]-3-sulfophenyl}diazen-1-yl]-10,12-dioxa-2,3-diaza-11-cupratricyclo[11.4.0.0^{4,9}]heptadeca-1(17),2,4,6,8,13,15-heptaene-6-sulfonate
- EC Number:
- 943-210-6
- Molecular formula:
- Not applicable. UVCB Substance
- IUPAC Name:
- tetrasodium 15-[(Z)-2-{4-[(E)-2-{4-[(E)-2-{2,5-dimethyl-4-[(E)-2-(4-sulfophenyl)diazen-1-yl]phenyl}diazen-1-yl]-2-sulfophenyl}ethenyl]-3-sulfophenyl}diazen-1-yl]-10,12-dioxa-2,3-diaza-11-cupratricyclo[11.4.0.0^{4,9}]heptadeca-1(17),2,4,6,8,13,15-heptaene-6-sulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: Russian breed- Weight at study initiation: 1.4 to 1.9 kg- Housing: kept separately in metal cages (overall dimensions 47x32x34cm)- Diet: Nafag, ad libitum- Water: drinking water ad libitum- Acclimation period: no dataENVIRONMENTAL CONDITIONS- Temperature (°C): 18 ± 1 °C- Humidity (%): 55 ± 5 %- Photoperiod (hrs dark / hrs light): 14 hours of light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.1 g
- Duration of treatment / exposure:
- direct injection in conjunctival sac
- Observation period (in vivo):
- 1, 6, 24, 48, 72 hours and 6, 8 days
- Number of animals or in vitro replicates:
- 3 males and 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE- Washing: with physiological salineTOOL USED TO ASSESS SCORE: slit lamp after 1 and 6 hours
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 162
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: No eye effect observed
- Remarks on result:
- other: rinsed after 1 minute
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 160
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: No eye effect observed
- Remarks on result:
- other: rinsed after 1 minute
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 153
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: No eye effect observed
- Remarks on result:
- other: rinsed after 1 minute
- Irritation parameter:
- iris score
- Basis:
- other: 162
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0
- Max. score:
- 2
- Reversibility:
- other: No eye effect observed
- Remarks on result:
- other: rinsed after 1 minute
- Irritation parameter:
- iris score
- Basis:
- animal: 160
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0
- Max. score:
- 2
- Reversibility:
- other: No eye effect observed
- Remarks on result:
- other: rinsed after 1 minute
- Irritation parameter:
- iris score
- Basis:
- animal: 153
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0
- Max. score:
- 2
- Reversibility:
- other: No eye effect observed
- Remarks on result:
- other: rinsed after 1 minute
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 162
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: rinsed after 1 minute
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 160
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: rinsed after 1 minute
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 153
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: rinsed after 1 minute
- Irritation parameter:
- chemosis score
- Basis:
- animal: 162
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: No eye effect observed
- Remarks on result:
- other: rinsed after 1 minute
- Irritation parameter:
- chemosis score
- Basis:
- animal: 160
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: rinsed after 1 minute
- Irritation parameter:
- chemosis score
- Basis:
- animal: 153
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: No eye effect observed
- Remarks on result:
- other: rinsed after 1 minute
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- not classified according to CLP Regulation (EC n. 1272/2008)
- Conclusions:
- Under the conditions of this experiment preparation the substance was found to cause non irritating when applied to the rabbit eye mucosa. Minimal reactions were observed after rinsing the eyes but fully reversible within 24 hours.
- Executive summary:
The substance has been tested for eye irritation according to the regulation on "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). Under the conditions of this experiment preparation the test item was found to be non irritating when applied to the rabbit eye mucosa. Minimal reactions were observed after rinsing eyes but fully reversible within 24 hours.
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