Registration Dossier
Registration Dossier
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EC number: 935-783-6 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant OECD guideline 431 study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 431 (In vitro skin corrosion / Human skin model test) (2004)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Preventol KMX
- IUPAC Name:
- Preventol KMX
- Test material form:
- solid - liquid: suspension
- Details on test material:
- - Name of test material (as cited in study report): Preventol KMX
- Physical state: yellowish, clear liquid
- Analytical purity: 100%
- Composition of test material, percentage of components: 54.3% 6-Chloro-m-cresol, 28.9% 2-Chloro-m-cresol, 11.6% m-cresol
- Lot/batch No.: CHP1502
- Storage condition of test material: Room temperature
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: reconstructed human epidermis EST-1000 (CellSystems, St. Katharinen, Germany)
- Details on test animals or test system and environmental conditions:
- TEST SYSTEM
- Source: CellSystems, St. Katharinen, Germany
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 37 ± 2
- Humidity (%): maximum
- CO2 gas concentration: 5 %
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: 0.9% NaCl
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 3min. (RT) and 60 min. in the incubator
- Number of animals:
- 3 inserts per period of incubation time and negative controls in triplicate
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: viability (in % of control)
- Value:
- 9.13
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 3 min. Max. score: 100.0. Reversibility: other: not applicable. Remarks: A test substance is considered corrosive if the cell viability is below 50% after 3 min exposure period.. (migrated information)
- Irritation / corrosion parameter:
- other: other: viability (in % of control)
- Value:
- 8.49
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 60 min. Max. score: 100.0. Reversibility: other: not applicable. Remarks: A test substance is considered corrosive if the cell viability is below 15% after 60 min exposure period.. (migrated information)
In vivo
- Irritant / corrosive response data:
- The cell viability was 9.13% after the 3 min exposure period and 8.49% after 60 minutes.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Classification was done in accordance with the existing guideline and internationally accepted protocols, i.e. evaluation of LD50 values after 3 min. and/or less than 15% viability after a 60 min. incubation period.
CLP: Skin corrosion, H314
DSD: C, R34
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