Registration Dossier
Registration Dossier
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EC number: 229-186-3 | CAS number: 6424-76-6
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
- Remarks:
- no GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations, Title 16, Section 1500.42
- GLP compliance:
- no
Test material
- Reference substance name:
- 17,18-dihydrodinaphtho[1',2',3':3,4;3'',2'',1'':9,10]perylo[1,12-efg][1,4]dioxocin-5,10-dione
- EC Number:
- 229-186-3
- EC Name:
- 17,18-dihydrodinaphtho[1',2',3':3,4;3'',2'',1'':9,10]perylo[1,12-efg][1,4]dioxocin-5,10-dione
- Cas Number:
- 6424-76-6
- Molecular formula:
- C36H18O4
- IUPAC Name:
- 17,18-dihydrodinaphtho[1',2',3':3,4;3'',2'',1'':9,10]perylo[1,12-efg][1,4]dioxocin-5,10-dione
- Test material form:
- solid: particulate/powder
- Details on test material:
- Vat Blue 16
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3 to 4 kg
- Housing: single
- Diet (ad libitum): standard pellet
- Water (ad libitum): tap
- Acclimation period: > 3 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 24 hours
no rinsing after treatment period - Observation period (in vivo):
- The eyes were examined 1, 24, 48, and 72 hours after application of the test substance.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: NA
TOOL USED TO ASSESS SCORE: opthalmoscope
SCORING SYSTEM: Draize
Evaluation
Evaluation covered pathological findings in the cornea (degree of opacity and area •affected), iris and conjunctivae (reddening, swelling and discharge). Evaluation details were based on the key given below, which was used to determine the irritation score.
Assessment key
From : The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA, 1959, p.51 (see below)
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:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.39
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Lacrimation
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.78
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- At 1 h, in most rabbits minimal erythema and edema was observed, accompanied with mild to moderate discharge.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Testing for primary eye irritation in the rabbit showed that the substance is not irritating to eyes.
- Executive summary:
100 mg of the test item was applied once to the conjunctival sac of the left eye of three rabbits. The untreated eyes served in each case as a control.
The treated eyes were examined 1, 24, 48 and 72 hours after application of the test substance.
No irritant effects were observed, hence the test substance is considered to be not irritating to the eye.
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