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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: 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:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Name Methyl Cyclopentenolone
Batch no. D270001706002
Appearance white, crystal powder
Composition Methyl Cyclopentenolone
Purity >99.0%
Homogeneity homogeneous
Expiry date 07. Jun. 2018
Storage Room Temperature (20 ± 5°C)
CAS No. 80-71-7
EINECS-No. 201-303-2
Stability in solvents H2O: unknown; EtOH: unknown; acetone: unknown;
CH3CN: unknown; DMSO: unknown
Solubility H2O: < 0,1 g/L; EtOH: >1 g/L; acetone: >1 g/L; CH3CN: >1
g/L; DMSO: >1 g/L
Structural Formula not stated
SMILES Code not stated

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
other: human-derived epidermal keratinocytes
Cell source:
other: commercially available, procured from MatTek In Vitro Life Science Laboratories, Bratislava
Source strain:
other: human
Vehicle:
not specified
Details on test system:
The test system is a commercially available EpiDermTM-Kit, procured by MatTek. The EpiDermTM tissue consists of human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis.
It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers representing main lipid classes analogous to those found in vivo. The EpiDermTM tissues are cultured on specially
prepared cell culture inserts.
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
Was used for treatment with the test item.
24.6 mg, 25.1 mg,24.7 mg
Duration of treatment / exposure:
60 minutes. Tissues were dosed in 1-minute-intervals.
Duration of post-treatment incubation (if applicable):
Tissues were dosed in 1-minute-intervals. After dosing the last tissue, all plates were
transferred into the incubator for 35 minutes at 37 ± 1°C and 5.0 ± 0.5% CO2.
1 hour after the first application, the inserts were removed from the plates using sterile forceps
and rinsed immediately in 1-minute-intervals.
After rinsing, each tissue was blotted with sterile cellulose tissue and then transferred into
a new 6-well-plate with fresh assay medium (0.9 mL).
Then, the tissues were set in the incubator for 23 hours 25 minutes at 37 ± 1°C and 5.0 ±
0.5% CO2.
Number of replicates:
3

Test animals

Species:
other: human
Strain:
other: human-derived epidermal keratinocytes

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Value:
> 96.2
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met