Registration Dossier
Registration Dossier
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EC number: 235-557-0 | CAS number: 12286-65-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: read across substance, almost no information about test substance, enviromental conditions and animals
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: see below
- Principles of method if other than guideline:
- "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Calcium bis[4-[[1-[[(2-methylphenyl)amino]carbonyl]-2-oxopropyl]azo]-3-nitrobenzenesulphonate]
- EC Number:
- 235-558-6
- EC Name:
- Calcium bis[4-[[1-[[(2-methylphenyl)amino]carbonyl]-2-oxopropyl]azo]-3-nitrobenzenesulphonate]
- Cas Number:
- 12286-66-7
- Molecular formula:
- C17H16N4O7S.1/2Ca
- IUPAC Name:
- calcium bis[4-({1-[(2-methylphenyl)carbamoyl]-2-oxopropyl}diazenyl)-3-nitrobenzenesulfonate]
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: English Silver strain
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: /
- Age at study initiation: /
- Weight at study initiation: /
- Housing: singly
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: /
ENVIRONMENTAL CONDITIONS
- Temperature (°C): /
- Humidity (%): /
- Air changes (per hr): /
- Photoperiod (hrs dark / hrs light): /
IN-LIFE DATES: From: To: /
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 30 sec until washing, 7 days without washing (observation period)
- Observation period (in vivo):
- 7d
- Number of animals or in vitro replicates:
- 3 per sex
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): 10 ml warm water
- Time after start of exposure: after 30 sec
SCORING SYSTEM: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO.
TOOL USED TO ASSESS SCORE: hand-slit lamp
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:
- 80
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 20
- Reversibility:
- fully reversible
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is to be considered as non irritant to the
eye of rabbits
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