Registration Dossier
Registration Dossier
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EC number: 444-010-7 | CAS number: 82654-98-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24.09.2009 - 28.10.2009
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: INVITTOX. 1992. Protocol No. 47: HET-CAM Test
- Deviations:
- no
- Principles of method if other than guideline:
- To determine the potential irritancy using an alternative to the Draize methodology. The methodology was based on that described in INVITTOX. 1992. Protocol No. 47: HET-CAM Test.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 444-010-7
- EC Name:
- -
- Cas Number:
- 82654-98-6
- Molecular formula:
- C12H18O3
- IUPAC Name:
- 4-(butoxymethyl)-2-methoxyphenol
Constituent 1
Test animals / tissue source
- Species:
- other: Hen's eggs (white Leghorn)
Test system
- Vehicle:
- other: Mazola Corn Oil
- Controls:
- yes
- Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- Continuously for 5 minutes
- Number of animals or in vitro replicates:
- 24 eggs
Results and discussion
In vivo
Results
- Irritation parameter:
- other: Classification of the irritating potential is according with the table on page 7 of the attached full study report
- Basis:
- other: See page 6 and 7 of the report
- Time point:
- other: 1 and 5 minutes after exposure
- Score:
- > 1 - < 5
- Max. score:
- 21
- Reversibility:
- other: Not applicable
Applicant's summary and conclusion
- Interpretation of results:
- other: None to slight
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Based on the threshold concentration of greater than 10% and the IS10% of 0, the irritating potential of CBE was determined as none to slight.
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