Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 700-689-4 | CAS number: 41524-32-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD Guidelines and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 431 and 439
- GLP compliance:
- yes
Test material
- Reference substance name:
- 6-(ethoxycarbonyl)-N,N-dimethyl-6-phenylcyclohex-2-en-1-aminium hydrogen oxalate
- EC Number:
- 700-689-4
- Cas Number:
- 41524-32-7
- Molecular formula:
- C17 H23 N O2 .C2 H2 O4
- IUPAC Name:
- 6-(ethoxycarbonyl)-N,N-dimethyl-6-phenylcyclohex-2-en-1-aminium hydrogen oxalate
- Details on test material:
- - Name of test material (as cited in study report): trans-tilidin Oxalat, Erstabtrennung
- Test substance No: 10/0345-1
- Homogeneity: The test substance was homogenous by visual inspection.
- Analytical purity: > 99.5%
- Purity test date: > 99.5%
- batch No.: LV 8/10
- Storage condition of test material: The stability under storage conditions over the study period was guarenteed by the sponsor, and the sponsor
holds this responsibility.
- Other: pH-value: ca. 3 (undiluted test substance, moistened with water)
Constituent 1
Test animals
- Species:
- other: Three dimensional human epidermis model
- Strain:
- other: in vitro method
- Details on test animals or test system and environmental conditions:
- TEST SYSTEM
Three dimensional human epidermis model
The EpiDermTM model consists of normal, 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 arranged in patterns analogous to those found in vivo. The EpiDermTM tissues (surface 0.6 cm²) are cultured on specially prepared cell culture inserts (MILLICELLs®, 10 mm ∅) and commercially available as kits (EpiDerm™ 200), containing 24 tissues on shipping agarose.
Tissue model: Epi-200 Origin: MatTek Corporation, Ashland MA, USA
Based on the results of ECVAM (European Center for Validation of Alternative Methods) funded validation studies, it was concluded by the ECVAM Scientific Advisory Committee that the EpiDerm™ human epidermis model is suitable to be used for distinguishing between corrosive and non-corrosive chemicals (ECVAM: ESAC statement on the application of the EpidermTM human skin model for skin corrosivity testing of 14-15 Mar 2000) as well as between irritant and non-irritant chemicals (ECVAM: ESAC statement on the scientific validity of in-vitro tests for skin irritation testing of 5 Nov 2008).
Test system
- Type of coverage:
- other: in vitro test
- Preparation of test site:
- other: in vitro test
- Duration of treatment / exposure:
- 3 min up to 1 hour
- Number of animals:
- in vitro test
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Irritation test: 3 min
- Value:
- ca. 96
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Corrosion test Exposure: 1h
- Value:
- ca. 94
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Corrosion test Exposure: 3 min
- Value:
- ca. 121
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
For details on results see below: "Overall remarks, attachments".
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Based on the observed results and applying the evaluation criteria it was concluded, that trans-tilidin-Oxalat, Erstabtrennung does not show a skin irritation potential in the EpiDerm skin corrosion/irritation test under the conditions chosen.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
