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
Study period:
2011-08-08 to 2011-10-21
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD Guideline for the Testing of Chemicals, Method No. 437, edition adopted 07 Sept. 2009: “Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants”
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals / tissue source

Species:
other: no animal testing
Details on test animals or tissues and environmental conditions:
NA

Test system

Vehicle:
not specified
Controls:
no
Amount / concentration applied:
No data
Duration of treatment / exposure:
No data
Observation period (in vivo):
NA
Number of animals or in vitro replicates:
NA
Details on study design:
NA

Results and discussion

In vivo

Results
Irritation parameter:
other: IVIS
Basis:
mean
Time point:
other: 10 min.
Score:
19.783
Reversibility:
other: NA
Remarks on result:
other: The test item Sika Hardener MH showed mild effects (according to ICCVAM classification) on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 19.7830.
Irritant / corrosive response data:
The test item Sika Hardener MH was brought onto the cornea of a bovine eye which previously had been incubated with cMEM without Phenol red at 32 ± 1 °C for one hour and whose opacity had been determined. The test item was incubated on the cornea for 10 minutes/four hours at 32 ± 1 °C. After removal of the test item and two hours post-incubation, opacity and permeability values were measured.
Physiological sodium chloride solution was used as negative control, sodium hydroxide (10% solution in 0.9% NaCl solution) was used as positive control.
The negative control showed no irritation, mean IVIS was 0.6620.
The positive control induced a very severe irritation on the cornea, mean IVIS was 210.4020.
The test item was tested pure. A mean IVIS of 19.7830 was calculated, corresponding to a ICCVAM classification as mild eye irritant.

Applicant's summary and conclusion

Interpretation of results:
other: not severely irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test item Sika Hardener MH showed mild effects (according to ICCVAM classification) on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 19.7830. According to OECD 437, Sika Hardener MH is considered as “non corrosive / no severe irritant”.
Executive summary:

The eye irritation potential of Sika Hardener MH was evaluated in the BCOP Test following OECD Guideline 437 dated September 2009. One valid experiment was performed.

Bovine corneas were used. They were collected from slaughtered cattle which were between 12 and 60 months old. The test item Sika Hardener MH was brought onto the cornea of a bovine eye which had been incubated with cMEM without phenol red at 32±1°C for one hour and whose opacity had been measured.

The test item was incubated on the cornea for 10 minutes at 32±1°C. After removal of the test item and two hours post-incubation, opacity and permeability values were measured.

Physiological sodium chloride solution was used as negative control. The negative control showed no irritating effect on the cornea.

10% sodium hydroxide solution was used as positive control. The positive control induced a very severe irritation on the cornea.

The test item Sika Hardener MH showed mild effects (according to ICCVAM classification) on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 19.7830.

In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item Sika HardenerMH possesses a mild eye irritation potential.

According to OECD 437, Sika Härter MH is considered as “non corrosive / no severe irritant”.