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EC number: 282-617-7 | CAS number: 84281-74-3
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: 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: Guideline study with acceptable restrictions performed on analogue substance 1
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations, Title 16, Section 1500.42
- Principles of method if other than guideline:
- The test was carried out by applying 100 µl bulk volume of the crystalline substance to the conjunctival sac of the lower right eyelid of rabbits that had been previously examined and had a mean weight of 2.3 kg. The lids were then gently held together for 1 sec. The eye was not washed after the application. The second, left eye of the rabbits always remained untreated as the control. The assessment was made with the aid of an ophthalmoscope.Cornea findings were verified after 8 days using the fluorescein test (instillation of 1 drop of fluorescein solution in an ophthalmological formulation directly onto the cornea. After washing with physiological saline solution corneal lesions appear yellow-green, UV light or cobalt blue-filter).Findings were obtained 24, 48 and 72 h and 8 days after the beginning of the study.
- GLP compliance:
- no
Test material
- Reference substance name:
- 1,3-bis(2,3-diaminophenylazo)benzene hydrochloride
- EC Number:
- 233-314-3
- EC Name:
- 1,3-bis(2,3-diaminophenylazo)benzene hydrochloride
- Cas Number:
- 10114-58-6
- Molecular formula:
- C18H18N8.2ClH
- IUPAC Name:
- Basic Brown 1 HCl
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: Versuchstierzuchten W. Ostrop, Meerbusch, FRG- Weight at study initiation: 2.3 kg- Housing: animais were housed in single cages- Diet: "muemmel z" feed (ssniff, Soest, FRG) ad libitum.- Water: ad libitum- Acclimation period: 4-6 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 16-18 °C- Humidity (%): 40%
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated eye served as control.
- Amount / concentration applied:
- TEST MATERIAL- Amount applied: 100 µl
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal:
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- conjunctivae score
- Basis:
- animal:
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
| 24h | 48h | 72h | 8 days | |||||||||||||||||||||
| Animal No. | 1 | 2 | 3 | 4 | 5 | 6 | 1 | 2 | 3 | 4 | 5 | 6 | 1 | 2 | 3 | 4 | 5 | 6 | 1 | 2 | 3 | 4 | 5 | 6 |
Cornea |
||||||||||||||||||||||||
| A) Opacity | 3 | 3 | 2 | 1 | 1 | 1 | 3 | 2 | 2 | 1 | 2 | 1 | 1 | 2 | 2 | 2 | 2 | 1 | 2 | 1 | 2 | 1 | 1 | 1 |
| B)Area | 4 | 4 | 4 | 1 | 1 | 3 | 3 | 2 | 2 | 1 | 3 | 2 | 3 | 1 | 1 | 1 | 1 | 1 | 4 | 1 | 1 | 1 | 1 | 1 |
| a=A*B*5 | 60 | 60 | 40 | 5 | 5 | 15 | 45 | 20 | 20 | 5 | 30 | 10 | 15 | 10 | 10 | 10 | 10 | 5 | ||||||
Iris |
2 | 2 | 2 | 2 | 1 | 2 | 2 | 2 | 2 | 1 | 1 | 2 | 2 | 2 | 2 | 1 | 1 | 2 | 2 | 1 | 2 | 1 | 1 | 2 |
| b=A*5 | 10 | 10 | 10 | 5 | 5 | 10 | 10 | 10 | 10 | 5 | 5 | 10 | 10 | 10 | 10 | 5 | 5 | 10 | ||||||
Conjunctivae |
||||||||||||||||||||||||
| A) Redness | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 2 | 3 | 3 | 3 | 3 | 1 | 2 | 1 | 1 | 3 |
| B) Swelling | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 2 | 2 | 2 | 4 | 4 | 3 | 2 | 3 | 2 | 3 | 2 | 2 | 1 | 2 | 1 | 1 | 2 |
| C) Discharge | 3 | 3 | 2 | 3 | 3 | 3 | 3 | 2 | 2 | 2 | 3 | 3 | 2 | 2 | 2 | 2 | 2 | 3 | 2 | 0 | 1 | 1 | 1 | 2 |
| c=(A+B+C)*2 | 20 | 20 | 18 | 20 | 20 | 20 | 20 | 14 | 14 | 14 | 20 | 20 | 16 | 14 | 14 | 14 | 16 | 16 | ||||||
| total= a+b+c(max. 110) | 90 | 90 | 68 | 30 | 30 | 45 | 75 | 44 | 44 | 24 | 55 | 40 | 41 | 34 | 34 | 29 | 31 | 31 | ||||||
Applicant's summary and conclusion
- Interpretation of results:
- other: classified under Regulation 1272/2008 H318, Eye Damage 1
- Conclusions:
- The analogue substance 1 was tested for eye irritation following Code of Federal Regulations, Title 16, Section 1500.42 . Under the experimental conditions and following critieria set by Regulation 1272/2008 the substance is classified as Eye Damage 1, H318: Causes serious eye damage (iris score > 1.5 for 4 animals out of 6).
- Executive summary:
The analogue substance 1 was tested for eye irritation following Code of Federal Regulations, Title 16, Section 1500.42 . Based on the iris average indexes at 24, 48 and 72h, under the experimental conditions and following critieria set by Regulation 1272/2008 the substance is classified as Eye Damage 1, H318: Causes serious eye damage.
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