Registration Dossier
Registration Dossier
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EC number: 240-267-2 | CAS number: 16102-99-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 - 04 Dec 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Disodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]anthracene-2-sulphonate
- EC Number:
- 240-267-2
- EC Name:
- Disodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]anthracene-2-sulphonate
- Cas Number:
- 16102-99-1
- Molecular formula:
- C22H18N2O11S3.2Na C22H16N2Na2O11S3
- IUPAC Name:
- disodium 1-amino-9,10-dioxo-4-({4-[2-(sulfooxy)ethanesulfonyl]phenyl}amino)-9,10-dihydroanthracene-2-sulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Albino New Zealand Rabbit
Food: Altromin 2123 rabbit
Water: deionised chlorinated water
Food and water ad libitum
Single housing
Weight: 2.4 - 2.9 kg
Age: ca. 3 - 5 months
Room temperature: 20°C
Relative air humidity: 50%
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 1, 24, 48, 72 h after exposure
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): 24 h after study initiation with physiological NaCl solution
SCORING SYSTEM: according to OECD TG 405
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
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Swellings occured 1 h after application in 3 / 3 animals. Swelling of conjuctivae occured 24 h after application in 1 / 3 animals. All signs of irritation were fully reversible within 48 h.
- Other effects:
- Hyperemia of conjunctival blood vessels in 3 / 3 animals
Iris coloured blue in 3 / 3 animals
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No significant signs of irritation occured in an OECD 405 with rabbits. All symptoms were fully reversible within 48 h (conjuctivae, chemosis). The test item does not fulfill the criteria for classification according to the CLP Regulation.
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