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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10-dec-2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
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

Constituent 1
Reference substance name:
Biomass residue (liquid) obtained after B2 production
IUPAC Name:
Biomass residue (liquid) obtained after B2 production

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µl per cornea

NEGATIVE CONTROL
- Amount(s) applied (volume or weight with unit): 750 µl per cornea
- physiological saline

POSITIVE CONTROL
- Amount(s) applied (volume or weight with unit): 750 µl per cornea
- Concentration (if solution): 10% (w/v) Benzalkonium Chloride

Duration of treatment / exposure:
10 minutes
Observation period (in vivo):
120 minutes
Details on study design:
TEST SITE
- Isolated bovine cornea

REMOVAL OF TEST SUBSTANCE

- Washing (if done): yes
- Time after start of exposure: 10 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 fluorescein

DATA EVALUATION:
- A test substance that induces an IVIS = 55.1 is defined as a corrosive or severe irritant.

Results and discussion

In vivo

Results
Irritation parameter:
other: In vitro irritancy score (IVIS)
Basis:
mean
Time point:
other: 10 minutes
Max. score:
0

Any other information on results incl. tables

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 (10% w/v Benzalkonium Chloride) was 146 and was within the historical positive control data range.It was therefore concluded that the test conditions were adequate and that the test system functioned properly.

 

Biomass residue (liquid) obtained after B2 production did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 0 after 10 minutes of treatment.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The positive and negative controls were within the historical control data.

Finally, it is concluded that this test is valid and that Biomass residue (liquid) obtained after B2 production is not irritant in the Bovine Corneal Opacity and Permeability test.

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