Registration Dossier
Registration Dossier
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EC number: 250-061-4 | CAS number: 30124-94-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations, Title 16, Section 1500.42 (US)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-[[4-[(2-cyano-3-nitrophenyl)azo]-m-tolyl](2-acetoxyethyl)amino]ethyl acetate
- EC Number:
- 250-061-4
- EC Name:
- 2-[[4-[(2-cyano-3-nitrophenyl)azo]-m-tolyl](2-acetoxyethyl)amino]ethyl acetate
- Cas Number:
- 30124-94-8
- Molecular formula:
- C21H21N5O6
- IUPAC Name:
- 2-[[4-[(2-cyano-3-nitrophenyl)azo]-m-tolyl](2-acetoxyethyl)amino]ethyl acetate
- Test material form:
- solid: granular
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 38 mg
- Observation period (in vivo):
- 7 d
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: no active removal
SCORING SYSTEM: Draize system
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:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- 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:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.4
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item caused no to very mild irritation in rabbit eyes at the beginning of the study. However, all signs of irritation disappeared after 72 h and were fully reversible. Therefore, the substance is not classifiable according to the CLP Regulation.
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