Registration Dossier
Registration Dossier
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EC number: 215-724-4 | CAS number: 1390-65-4
Eye irritation
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:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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 substance name:
- Carmine
- EC Number:
- 215-724-4
- EC Name:
- Carmine
- Cas Number:
- 1390-65-4
- Molecular formula:
- C22H20O13
- IUPAC Name:
- Carmine
- Test material form:
- solid
Constituent 1
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
