Registration Dossier
Registration Dossier
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EC number: 849-913-3 | CAS number: 93216-90-1
Skin irritation / corrosion
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:
- 2 020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1-(4-methoxyphenyl)-2-methyl -2-morpholinopropan-1-one
- EC Number:
- 849-913-3
- Cas Number:
- 93216-90-1
- Molecular formula:
- C15H21NO3
- IUPAC Name:
- 1-(4-methoxyphenyl)-2-methyl -2-morpholinopropan-1-one
- Test material form:
- solid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Details on animal used as source of 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:
- 1 replicate 26.3 mg
2 replicate 26.4 mg
3 replicate 25.2 mg - Duration of treatment / exposure:
- 19 hours and 40 minutes
- Duration of post-treatment incubation (if applicable):
- 1 hour
- Number of replicates:
- 3
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 111.5
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- other: non-irritant to skin
- Conclusions:
- The test item 1-(4-methoxyphenyl)-2-methyl-2-(morpholin-4-yl)propan-1-one is considered as non-irritant to skin.
After the treatment, the mean value of relative tissue viability was 111.5%. This value is above the threshold for skin irritation (50%).
The optical density of the negative control was well within the required acceptability crite-rion of 0.8 ≤ mean OD ≤ 2.8.
The positive control has met the acceptance criterion too, for thus ensuring the validity of the test system.
The variation within replicates was within the accepted range for negative control, positive control and test item (required: ≤ 18%).
For these reasons, the result of the test is considered valid.
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