Registration Dossier
Registration Dossier
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EC number: 215-724-4 | CAS number: 1390-65-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study will be available 31/08/2019
- 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 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
- Deviations:
- yes
- Remarks:
- The volume of test item corresponding to 500 mg was very large, thus it was not possible to add the whole quantity on the membrane surface. The substance used was in excess of the treated area, the deviation has affected the integrity of the study.
- 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
In vitro test system
- Test system:
- artificial membrane barrier model
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Negative control: 500 microliters
Positive control: 500microliters
Test item: 500 miligrams - Number of replicates:
- Negative control: 1 replicate
Positive control: 1 replicate
Test item: 4 replicates
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Run / experiment:
- test item
- Value:
- > 65
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The assay was considered valid if the following criteria were met:
– the positive control should give the expected penetration response time (historical mean value + 3 SD), based on RTC historical control values (12.33±6.75 minutes; n = 16).
– the negative control should not be corrosive within 60 minutes.
Applicant's summary and conclusion
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.
