Registration Dossier
Registration Dossier
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EC number: 283-294-5 | CAS number: 84604-16-0 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Saccharomyces cerevisiae, Saccharomycelaceae.
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14-jun-2010 to 15-jun-2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- OECD 437
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guideline 437 “Bovine corneal opacity and permeability (BCOP) test method for identifying ocular corrosives and severe irritants”
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Saccharomyces cerevisiae, ext.
- EC Number:
- 283-294-5
- EC Name:
- Saccharomyces cerevisiae, ext.
- Cas Number:
- 84604-16-0
- Molecular formula:
- Not applicable as the substance is an UVCB
- IUPAC Name:
- Yeast extract, Saccharomyces cerevisiae
- Details on test material:
- - Name of test material (as cited in study report): Saccharomyces cerevisiae, Extract (Springer 0207/0-MG-L)
- Substance type: Light beige powder
- Physical state: Solid
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark
Constituent 1
Test system
- Vehicle:
- physiological saline
- Amount / concentration applied:
- - Amount(s) applied (volume or weight with unit): 750 µl per cornea
- Concentration (if solution): 20% (w/w)
NEGATIVE CONTROL
- Amount(s) applied (volume or weight with unit): 750 µl of physiological saline per cornea
POSITIVE CONTROL
Amount(s) applied (volume or weight with unit): 750 µl per cornea
Concentration (if solution): 20% (w/v) Imidazole - Duration of treatment / exposure:
- 240 minutes
- Details on study design:
- TEST SITE
- Isolated bovine cornea
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 240 minutes
SCORING SYSTEM:
- After exposure the cornea is thoroughly rinsed to remove the test substance followed by immediate opacity measurement and permeability evaluation of the cornea.
- The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro score:
In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).
TOOL USED TO ASSESS SCORE:
- opacitymeter and microplate reader
DATA EVALUATION:
A test substance that induces an IVIS ≥ 55.1 is defined as a corrosive or severe irritant
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- after 240 minutes of treatment
- Value:
- ca. 3.3
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- other: not severe irritant or corrosive
- Conclusions:
- The positive and negative controls were within the historical control data.
Saccharomyces cerevisiae, Extract (Springer 0207/0-MG-L) did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 3.3 after 240 minutes of treatment.
Finally, it is concluded that this test is valid and that Saccharomyces cerevisiae, Extract (Springer 0207/0-MG-L) is not severe irritant or corrosive in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in this report. - Executive summary:
Saccharomyces cerevisiae, Extract (Springer 0207/0 -MG-L) was tested for ocular irritation on an isolated bovine cornea. The possible ocular irritancy ofSaccharomyces cerevisiae, Extract (Springer 0207/0-MG-L) was tested through topical application for 240 ± 10 minutes. The test substance was applied as a 20% (w/w) solution (750 µl) directly on top of the corneas.
The negative control responses of the opacity and permeability values were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (20% w/v Imidazole) was 119 and within the historical positive control data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.
Saccharomyces cerevisiae, Extract (Springer 0207/0 -MG-L) did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 3.3 after 240 minutes of treatment.
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