Registration Dossier

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline used

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD Guideline no. 437
Deviations:
no
Principles of method if other than guideline:
Bovine corneal opacity and permeability test (BCOP test)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Purity: 98,9%

Test animals / tissue source

Species:
other: Bovine

Test system

Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
Negative control: 750 µl physiological saline
Positive control: 750 µl 20% (w/v) imidazole solution
4B-Acid: 750 µl 20% (w/v) 4B-acid suspension
Duration of treatment / exposure:
240±10 min

Results and discussion

In vitro

Results
Irritation parameter:
cornea opacity score
Run / experiment:
240 min.
Value:
ca. 24
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 240 min
Score:
24
Reversibility:
not specified
Irritant / corrosive response data:
Opacity score:
Eye Opacity before treatment Opacity after treatment Final opacity Negative control corrected final opacity Mean opacity
Negative control
1 0 0 0 0
2 0 1 1 1 0
3 0 0 0 0
Positive control
4 0 80 80 80
5 0 79 79 79 80
6 0 81 81 81
4B-Acid
13 0 19 19 19
14 0 29 29 29 24
15 0 24 24 24

Permeability score(corrected):
Eye Dilution factor OD490-1 OD490-2 OD490-3 Average OD Dilution corrected final OD Dilution corrected average OD
Negative control
1 1 0,014 0,001 0,004 0,006 0,006
2 1 0,000 0,000 0,003 0,001 0,001 0,000
3 1 -0,001 -0,008 -0,009 -0,006 -0,006
Positive control
4 6 0,369 0,366 0,372 0,369 2,214
5 6 0,349 0,362 0,354 0,355 2,130 2,490
6 6 0,527 0,518 0,519 0,521 3,126
4B-acid
13 1 -0,010 -0,008 -0,006 -0,008 -0,008
14 1 -0,004 0,002 -0,006 -0,003 -0,003 -0,006
15 1 -0,009 -0,005 -0,006 -0,007 -0,007

Any other information on results incl. tables

In vitro irritability score (IVIS) = mean opacity value + (15*mean OD490 value)

Mean opacity Mean permeability Mean IVIS
Negative control 0 0,000 0
Positive control 80 2,490 117
4B-acid 24 -0,006 24

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The mean in vitro irritancy score was 24 after 240 minutes of treatment with 4B-acid. Since this is below 55,1 4B-acid is considered to be Non-irritating