Registration Dossier
Registration Dossier
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EC number: 700-736-9 | CAS number: 2149571-40-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 March 2013 - 19 April 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to the OECD test Guideline and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (1R,2S,10R,11S)-tetracyclo[9.2.1.0²,¹⁰.0³,⁸]tetradeca-3(8),4,6,12-tetraene
- EC Number:
- 700-736-9
- Cas Number:
- 2149571-40-2
- Molecular formula:
- C14H14
- IUPAC Name:
- (1R,2S,10R,11S)-tetracyclo[9.2.1.0²,¹⁰.0³,⁸]tetradeca-3(8),4,6,12-tetraene
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): 7,8-benzotricyclo[4.3.0.1(2.5)]deca-3-ene (MTF)
- Substance type: Organic
- Physical state: transparent liquid
- Analytical purity: ca 100%
- Lot/batch No.: M1204
- Expiration date of the lot/batch: 31 December 2015
- Storage condition of test material: Room temperature (ca 20ºC)
Constituent 1
Test animals / tissue source
- Species:
- other: Bovine eyes
Test system
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- 10 mins (+/- 30 seconds) at 32°C 1°C
- Observation period (in vivo):
- two hour (+/- 10 minutes) incubation period
- Number of animals or in vitro replicates:
- n/a
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Mean
- Value:
- ca. -1
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean
- Value:
- ca. -1
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- other: non-corrosive/non-severe eye irritant
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test substance, MTF, elicited an In Vitro Irritancy Score of -1.0 ± 0.1 and was predicted to be a non-corrosive/non-severe eye irritant.
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