Registration Dossier
Registration Dossier
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EC number: 205-009-5 | CAS number: 131-08-8
Eye irritation
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:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- To one male and two female rabbits about 0.1 ml of undiluted Luprintan TX 4493 (= Anthraquinone-2-sulfonic acid sodium salt) was applied to the conjunctival sac of the right eyelid. The substance was not washed out. Readings according to Draize were done after 1, 24, 48 and 72 hours after the application.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sodium 9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
- EC Number:
- 205-009-5
- EC Name:
- Sodium 9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
- Cas Number:
- 131-08-8
- Molecular formula:
- C14H8O5S.Na
- IUPAC Name:
- sodium 9,10-dioxo-9,10-dihydroanthracene-2-sulfonate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- Animals species: Rabbit / White Vienna
Animal breeder: Gaukler, D-6050 Offenbach, FRG
Acclimatisation: At least 8 days before the beginning of the study
Type of cage: Stainless steel wire mesh walk floors (40 cm x 51 cm)
No. animals per cage: 1
Room temperature/ The animals were housed in fully air-conditioned rooms (20 - 24°C; relative humidity 30 - 70°C).
relative humidity
Day/night rhythm: 12 hours / 12 hours
Drinking water: About 250 ml tap water per animal per day
Diet: Kliba 341
Clipping of the fur: At least 15 hours before the beginning of the study
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml (unchanged)
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 72 hours
- Duration of post- treatment incubation (in vitro):
- None
- Number of animals or in vitro replicates:
- 1 male and 2 female rabbits
- Details on study design:
- Number of animals: 1 male and 2 female rabbits
Mean weight: male: 2.79 kg; female: 3.12 kg
Application volume: 0.1 ml (unchanged)
Application site: single application to the conjunctival sac of the right eyelid; the substance was not washed out
Observation period: 72 hours
Readings: 1, 24, 48 and 72 hours after the application
Negative control: untreated eye
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
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0 at any time point
- Irritant / corrosive response data:
- The cornea, iris, conjunctivae and chemosis score was 0 at 24, 48 and 72 hours.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The cornea, iris, conjunctivae and chemosis score was 0 at 24, 48 and 72 hours.
- Executive summary:
To one male and two female rabbits about 0.1 ml of undiluted Luprintan TX 4493 (= Anthraquinone-2-sulfonic acid sodium salt) was applied to the conjunctival sac of the right eyelid. the substance was not washed out. Readings according to Draize were done after 1, 24, 48 and 72 hours after the application. The cornea, iris, conjunctivae and chemosis score was 0 at 24, 48 and 72 hours. Therefore Luprintan TX 4493 (= Anthraquinone-2-sulfonic acid sodium salt) is not irritating to the eyes.
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