Registration Dossier
Registration Dossier
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EC number: 943-692-8 | CAS number: -
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
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The test was conducted by means of Read Across approach. Further information was attached at section 13
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- .
- GLP compliance:
- no
Test material
- Reference substance name:
- Acid Black 071 - Similar Substance 01
- IUPAC Name:
- Acid Black 071 - Similar Substance 01
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Albino
- Details on test animals or tissues and environmental conditions:
- Housing period: > 3 days
light and dark cycle: 12 hours of light/12 hours of darkness from 7 to 19
Temperature: 22 +/- 1°C
Relative humidity: 55 +/- 10%
cages: stainless steel without bedding
number of animals per cage: 1
number of animals per group: 6
Feed: standard pellets for rabbits
Feed and drink: ad libitum
Distribution of animals per group: randomly
body weight: 3 to 4 kg
Test system
- Controls:
- other: untreated eye
- Amount / concentration applied:
- Volume of applications: 0.1 ml for liquids
100 mg for solid substances (possibly ground) - Observation period (in vivo):
- 1, 24, 48 and 72h after instillation
- Details on study design:
- site of application: right or left eye. No rinsing ogf the ey after application. When the irritation was still present at 72h also reading at 7 days was performed
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- over 6 animals
- Time point:
- other: mena at 24, 48 and 72h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- over 6 animals
- Time point:
- other: mean at 24, 48 and 72h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: mean at 24, 48 and 72h
- Score:
- ca. 0.3
- Max. score:
- 1
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- other: mean at 24, 48 and 72h
- Score:
- ca. 1
- Max. score:
- 1
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- other: mean at 24, 48 and 72h
- Score:
- ca. 0.3
- Max. score:
- 1
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #4
- Time point:
- other: mean at 24, 48 and 72h
- Score:
- ca. 0.3
- Max. score:
- 1
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #5
- Time point:
- other: mean at 24, 48 and 72h
- Score:
- ca. 0.3
- Max. score:
- 1
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #6
- Time point:
- other: mean at 24, 48 and 72h
- Score:
- ca. 1.3
- Max. score:
- 2
- Irritant / corrosive response data:
- 1h after application of the test substance was in all rabbit slight to moderate swelling of the conjunctiva and slight to strong secretion of the treated eyes observed.
24h to 48h after application all the rabbits conjunctiva were stained by the test substance. 7 d after application all rabbit were without effects
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- The substance was tested for eye irritation. Under the experimental conditions the substance does not show eye irritation potential.
- Executive summary:
The substance was tesetd for eye irritation. Albino rabbtis were instilled in one eye with the substance while the un treated eye served as control. Observation period was set at 24, 48 and 72h and again at 7 days. Under the experimental conditions the substance does not show any eye irritation potential.
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