Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 june 2017
Reliability:
1 (reliable without restriction)
Justification for type of information:
The study was performed in compliance with the following regulations or guidelines:
• OECD Guideline for the Testing of Chemicals No. 437 (updated 26 July 2013) “Bovine Corneal Opac
ity and Permeability Assay”
• Method B.47 of Commission Regulation (EC) No. 440/2008

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)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
White powder
Specific details on test material used for the study:
Batch: 18128093
Purity: 100.5%

Test animals / tissue source

Species:
cattle
Details on test animals or tissues and environmental conditions:
Test System: Freshly isolated bovine cornea (at least 9 month old donor cattle)
Rationale: OECD 437
Source: AB Schlachthof GmbH & Co. KG, 63739 Aschaffenburg, Germany

Test system

Controls:
yes, concurrent positive control
yes, concurrent negative control

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
ca. 0.53
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In conclusion, according to the current study and under the experimental conditions reported, CARBANINE CRIST is not categorized (GHS).