Registration Dossier
Registration Dossier
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EC number: - | 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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.40 BIS: “In Vitro Skin Corrosion: Human Skin Model Test”, May 30, 2008
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tricyclo[8.2.2.24,7]hexadeca-4,6,10,12,13,15-hexaene, 5,11,13,15-tetramethyl-
- Cas Number:
- 205825-52-1
- Molecular formula:
- C20H24
- IUPAC Name:
- Tricyclo[8.2.2.24,7]hexadeca-4,6,10,12,13,15-hexaene, 5,11,13,15-tetramethyl-
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Batch no. 350321
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Justification for test system used:
- The EpiDerm Skin Model is a well-established organotypic, three-dimensional model of the human epidermis and is used for in vitro experiments since many years. It is known for its similarity to human skin.
- Details on test system:
- The test was performed on a total of 4 tissues per dose group, 2 replicates for each treatment period
(3 min and 60 min exposure time). - Control samples:
- yes, concurrent negative control
- Amount/concentration applied:
- Negative control 50 µL distilled water
Positive control 50 µL 8 N KOH
Test Item 25 mg + 50 µL H2O - Duration of treatment / exposure:
- 3 min and 60 min exposure time
- Number of replicates:
- 2 replicates for each treatment period
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minutes
- Value:
- > 15
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minutes
- Value:
- > 50
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Corrosivity potential of the test item was predicted from the relative mean tissue viabilities obtained
after both treatment periods had been compared to the corresponding negative control tissues.
The test item has no non-specific MTT-reducing or colouring potential, therefore no additional controls
were necessary.
The test item showed no corrosive effects. The mean relative tissue viability (% negative control) was
≥ 50% (102.5%) after 3 min treatment and ≥ 15% (89.6%) after 60 min treatment.
The controls confirmed the validity of the study. The mean OD570nm of the two negative control tissues
was ≥ 0.8 and ≤ 2.8 for each exposure period (1.907, 1.945). The mean relative tissue viability
(% negative control) of the positive control was ≤ 15% (5.6%) after 60 min treatment. The coefficient
of variation (CV) (in the range of 20 – 100% viability) of replicate tissues of all dose groups was ≤ 30%
(1.4% - 8.7%).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study under the given conditions the test item showed no corrosive effects. The test item is
classified as “non-corrosive“. - Executive summary:
In the present study the skin corrosivity potential of PARYFREE® DIMER was analysed. Since corrosive chemicals are cytotoxic after a short time exposure to the stratum corneum of the epidermis
the cytotoxic effects of the test item on EpiDerm, a reconstituted three-dimensional human epidermis
model, were determined. Hereby, the test item was applied topically. Cytotoxicity is expressed as the
reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after
a 3 min and 60 min exposure period and compared to those of the concurrent negative controls.
The test item has no non-specific MTT-reducing or colouring potential, therefore no additional controls
were necessary.
The test item showed no corrosive effects. The mean relative tissue viability (% negative control) was
≥ 50% (102.5%) after 3 min treatment and ≥ 15% (89.6%) after 60 min treatment.
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