Registration Dossier
Registration Dossier
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EC number: 604-582-2 | CAS number: 1472-93-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 January 2012 to 02 February 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of inspection 2011-07-19 to 2011-07-21; Date of signature 2011-08-31
Test material
- Reference substance name:
- methyl 9-decenoate
- EC Number:
- 662-772-0
- Cas Number:
- 25601-41-6
- Molecular formula:
- C11H20O2
- IUPAC Name:
- methyl 9-decenoate
- Details on test material:
- - Name of test material (as cited in study report): 9-decenoic acid, methyl ester
- Molecular formula: C11H20O2
- Molecular weight: 184.28
- Smiles notation: COC (=O)CCCCCCCC=C
- CAS number: 25401-41-6
Physical property inputs:
- Log Kow (octanol-water): 4.60
- Boiling Point (deg C): 235.00
- Melting Point (deg C): -20.00
- Vapour Pressure (mm Hg): 0.098
- Water solubility (mg/L): 7.81
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- One animal was treated initially. After consideration of the ocular responses produced in the first animal, two additional animals were treated.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48 hours
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item is considered to be not irritating to the rabbit eye and is not classified in accordance with CLP Regulation No (EC) 1272/2008.
- Executive summary:
An in vivo study was performed to assess the the eye irritation potential of the test item in New Zealand white rabbit, according to OECD Guideline 405, in compliance with GLP. A single application of the test item to the non-irrigated eye of three rabbits produced moderate conjunctival irritation. One treated eye appeared normal at the 48 hour observation and two treated eyes appeared normal at the 72 hour observation. Based on the classification criteria for eye irritation according to Regulation (EC) No.
1272/2008, 9-decenoic acid, methyl ester is considered to be non-irritating to eyes (Harlan Laboratories Ltd, 2012).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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