Registration Dossier
Registration Dossier
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EC number: 228-995-9 | CAS number: 6388-26-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From April 10 to 19, 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 2004
- GLP compliance:
- no
Test material
- Reference substance name:
- Direct Green 026
- IUPAC Name:
- Direct Green 026
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Amount / concentration applied:
- 0.1 ml (69.3 mg)
- Observation period (in vivo):
- 72 h
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- washing: no
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Other effects:
- Black staining of the nictitating membrane and of the fur around the treated eye was noted.
Any other information on results incl. tables
| effect | 24 h | 48 h | 72 h | ||||||
| rabbit no. | |||||||||
| 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | |
| cornea opacity | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| conjunctivae redness | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| conjunctivae chemosis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not irritant to the rabbit eye.
- Executive summary:
Method
Eye irritation in rabbits according to OECD guideline 405.Test substance was applied to the non irrigated eye of 3 rabbits as single application of 0.1 ml (69.3 mg). Observations for signs of irritation on cornea, iris and conjunctivae were done 1, 24, 48 and 72 hours after instillation.
Results
Conjunctival redness was noted in all treated eyes at the 24 -hour observation. However, all treated eyes appeared normal at the 48 -hour observation. Black staining of the nictitating membrane and of the fur around the treated eye was also noted.
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