Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
The study will be availabele 30/12/2018
Reliability:
1 (reliable without restriction)
Justification for type of information:
The dossier is submitted under DCG issue 10.3 as communicated to ECHA in communication INC000000234289. Incomplete endpoint summary records are indicated in the relevant sections of the dossier. Complete information is not availabole for CSR or Guidance on safe use.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals / tissue source

Species:
other: Bos primigenius Taurus (fresh bovine corneas)
Strain:
not specified

Test system

Vehicle:
Hank's balanced salt solution
Remarks:
Hank’s Balanced Salt Solution (HBSS) was used as negative control
Controls:
yes, concurrent positive control
yes, concurrent negative control
Duration of treatment / exposure:
Exposure time of controls and test item on the corneas was 10 minutes at 32 ± 1 °C. After thorough rinsing the anterior chamber with cMEM with phenol red and final rinsing with cMEM without phenol red, the anterior chamber is filled with cMEM without phenol red and the corneaholder are stored for additional 2 hours at 32 ± 1 °C (post-incubation). Then, the final illuminance value of each cornea was recorded.

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
ca. 2.51
Vehicle controls validity:
not specified
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the test item CARMINE LAKE showed no effects on the cornea of the bovine eye. The calculated mean IVIS was 2.51.
According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS ≤ 3 re-quires no classification for eye irritation or serious eye damage