Registration Dossier
Registration Dossier
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EC number: 228-036-4 | CAS number: 6092-54-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, available as unpublished report, no restrictions, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Two EpiOcular™ tissue samples were incubated with 50 μL of the test substance for 30 minutes followed by a 2-hour post-incubation period.
- GLP compliance:
- no
Test material
- Reference substance name:
- Hexyl chloroformate
- EC Number:
- 228-036-4
- EC Name:
- Hexyl chloroformate
- Cas Number:
- 6092-54-2
- Molecular formula:
- C7H13ClO2
- IUPAC Name:
- hexyl carbonochloridate
- Details on test material:
- - Name of test material (as cited in study report): n-Hexylchloroformate
- Physical state: liquid
Constituent 1
Test animals / tissue source
- Species:
- other: reconstructed human cornea model EpiOcular™
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Positive and negative controls
- Amount / concentration applied:
- 50 μL
- Duration of treatment / exposure:
- 30 minutes followed by a 2-hour post-incubation period
- Details on study design:
- - Two EpiOcular™ tissue samples were incubated with 50 μL of the test substance for 30 minutes followed by a 2-hour post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the test substance treated epidermal tissues is compared to that of negative control tissues (relative tissue viability).
- Negative control: de-ionized water, sterile
- Positive control: methyl acetate (98+%, CAS No.: 79-20-9)
- The irritation potential of the test material is predicted from the mean relative tissue viabilities compared to the negative control tissues concurrently treated with sterile water. A chemical is considered as "irritant", if the mean relative tissue viability with a test material is less than or equal to 50%. At present no prediction is performed if the mean relative tissue viability with a test material is > 50 ≤ 60% as the cut off value is currently being evaluated to lie in this range.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: Cell viablity
- Basis:
- mean
- Time point:
- other: 30 minutes
- Score:
- 76
- Remarks on result:
- other: % viablity relative to control
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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