Registration Dossier
Registration Dossier
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EC number: 306-764-4 | CAS number: 97404-02-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- In vitro Skin Irritation and Corrosion with EpiDerm
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22Apr2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-[(4-aminophenyl)azo]-1,3-dimethyl-1H-imidazolium chloride
- EC Number:
- 306-764-4
- EC Name:
- 2-[(4-aminophenyl)azo]-1,3-dimethyl-1H-imidazolium chloride
- Cas Number:
- 97404-02-9
- Molecular formula:
- C11H14N5.Cl
- IUPAC Name:
- 2-[(1E)-2-(4-aminophenyl)diazen-1-yl]-1,3-dimethyl-2,3-dihydro-1H-imidazol-1-ium chloride
- Test material form:
- solid: particulate/powder
- Details on test material:
- See individual study reports for purity information and CofA where applicable
Constituent 1
- Specific details on test material used for the study:
- Test substance No.: 14/0424-1
Batch identification: 0008205061
CAS No.: 97404-02-9
Physical state / color: Solid / red
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell source:
- other: Human reconstituted epidermis model EpiDerm™
- Control samples:
- yes, concurrent MTT non-specific colour control
- other: freeze-killed control tissues (KC CC)
- Amount/concentration applied:
- Form of application: undiluted
Negative control (NC): De-ionized water (corrosion test) I PBS, sterile (irritation test)
Positive control (PC): 8 N KOH (corrosion test) / 5% SOS in de-ionized water, sterile (irritation test)
MTT-reduction control (KC): De-ionized water or test substance (corrosion test) PBS, sterile or test substance (irritation test)
Color control (CC): Test substance
Killed color control (KC CC): Test substance - Duration of treatment / exposure:
- The test consists of a single topical exposure of the undiluted test substance to the surface of a human reconstituted epidermis model EpiDerm™ for 3 minutes and 1 hour (corrosion test) or 1 hour with 42 hours postincubation (irritation test) followed by a cell viability test.
- Duration of post-treatment incubation (if applicable):
- The test consists of a single topical exposure of the undiluted test substance to the surface of a human reconstituted epidermis model EpiDerm™ for 3 minutes and 1 hour (corrosion test) or 1 hour with 42 hours postincubation (irritation test) followed by a cell viability test.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Irritation test, 1 hour exposure
- Value:
- 74
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Corrosion test, 3 min exposure
- Value:
- 105.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Corrosion test, 1 hour exposure
- Value:
- 94.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the observed results and applying the evaluation criteria it was concluded, that the test item does not show a skin irritation potential in the EpiDerm TM in vitro skin irritation and corrosion test strategy under the test conditions chosen .
- Executive summary:
Based on the observed results and applying the evaluation criteria it was concluded, that the test item does not show a skin irritation potential in the EpiDermTM in vitro skin irritation and corrosion test strategy under the test conditions chosen.
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