Registration Dossier

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:
guideline study
Cross-reference
Reason / purpose:
read-across: supporting information

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Chemical Name Lauryl betaine
Physical State liquid - The sample was dried under a nitrogen purge to remove water prior to analysis.
CAS # 683-10-3
EU # 211-669-5
Manufacturer Colonial Chemical
Batch/lot # 53715J16
Received on November 22, 2016
Tested on January 31, 2017
Specific details on test material used for the study:
ColaTeric LAB-70UP product was supplied by Colonial for this test.
The lot # was 55880C17. This product contains lauryl betaine (C12) at 35% active strength in water.

Test system

Vehicle:
physiological saline
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
The ColaTeric product was applied at 10% in saline. This infers that the strength of the active that was applied was 3.5%
A volume of 0.75ml was applied uniformly to the bovine cornea under conditions specified in the method.
Duration of treatment / exposure:
10 minutes, followed by a minimum of three washes.
Duration of post- treatment incubation (in vitro):
2 hours
Number of animals or in vitro replicates:
Three corneas were used per article.

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
in vitro irritation score
Remarks:
Mean score for three readings
Value:
30.7
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks:
Mean in-vitro score = 46.0
Irritation parameter:
cornea opacity score
Remarks:
Mean score for three results
Value:
12
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks:
Mean opacity score = 27.3
Other effects / acceptance of results:
Acceptance criteria was met as being within 2 standard deviations of the current historical mean at the testing facility.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Under the conditions of the test, the sample eliicited an average in vitro score of 30.7.
The positive control elicited an average in vitro score of 46.0.
Under the decision cirteria of this test, these values fall within the 'No prdictions can be made' category, but is close to the level for th positive control and threfore a classification of Eye Irrit 2 is recommended.
Note that it was impossible to remove water and classification is basedon the 35% actives material as supplied.