Registration Dossier
Registration Dossier
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EC number: 609-869-6 | CAS number: 40834-42-2
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:
- other: According to OECD-guideline 405 and EC method. GLP compliant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 5-hydroxy-4-methyl-2,5-dihydrofuran-2-one
- EC Number:
- 609-869-6
- Cas Number:
- 40834-42-2
- Molecular formula:
- C5 H6 O3
- IUPAC Name:
- 5-hydroxy-4-methyl-2,5-dihydrofuran-2-one
- Reference substance name:
- Hydroxybutenolid
- IUPAC Name:
- Hydroxybutenolid
- Details on test material:
- - Name of test material (as cited in study report): Hydroxybutenolid
- Test substance number: 00/0213-1
- Substance type: solid/yellowish-white powder
- Analytical purity: 92.7%
- Purity test date: July 10, 2000
- Date of manufacture: March 6, 2000
- Stability under test conditions: stability in DMSO and water has not been determined analytically.
- Storage condition of test material: room temperature
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Duration of treatment / exposure:
- 1 h, than washout.
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 2
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: animal 1 and 2
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: individual scores: 0 - 0 - 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: individual scores: 1 - 1 - 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: individual scores: 1 - 0 - 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: individual scores: 2- 3 - 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: individual scores: 2 - 3 - 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: individual scores: 3 - 2 - 1
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: individual scores: 3 - 3 - 2
- Other effects:
- effects mentioned in "Any other information on materials and methods incl. tables".
Any other information on results incl. tables
The test substance was found to be irritant in the acute eye irritation test with rabbits, presented herein.
Applicant's summary and conclusion
- Conclusions:
- Based of the results presented in this study, hydroxybutenolid has to be classified "irritant to eyes", R 36 (67/548/EWG) and Cat 2 (H319) according to CLP (1272/2008/EC)
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