Registration Dossier
Registration Dossier
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EC number: 218-145-5 | CAS number: 2052-25-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study non-GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sodium 3-[(1,5-dihydroxy-2-naphthyl)azo]-4-hydroxybenzenesulphonate
- EC Number:
- 218-145-5
- EC Name:
- Sodium 3-[(1,5-dihydroxy-2-naphthyl)azo]-4-hydroxybenzenesulphonate
- Cas Number:
- 2052-25-7
- Molecular formula:
- C16H(12-x)N2NaxO6S x <= 1
- IUPAC Name:
- sodium 3-[2-(1,5-dioxonaphthalen-2-yl)hydrazinyl]-4-hydroxybenzenesulfonate
- Details on test material:
- Diamantschwarz PV 200%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK ltd
- Age at study initiation: -
- Weight at study initiation: 3.3 to 3.5 kg
- Housing: single
- Diet (ad libitum): ssniff K4, Versuchsdiäten GmbH, Soest
- Water (ad libitum): tap water
- Acclimation period: at least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23
- Humidity (%): 45 to 65
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: July 1986
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 µL
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): NaCl-solution
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: hand-slit lamp + fluorescein + UV-light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1,2,3
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: 1,2,3
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening
- Basis:
- animal: #2 and #3
- Time point:
- other: 24-72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: #2 and #3
- Time point:
- other: 24-72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- No effects were seen on day 14. Therefore, no evaluation was done on day 21
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Slightly irritating according to study report.
Not irritating according to Regulation (EC) No 1272/2008
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