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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 202-858-3 | CAS number: 100-50-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Principles of method if other than guideline:
- The experiment was carried out on a reconstructed human epidermis EST-1000 (CeIlSystems, St. Katharinen, Germany).
- GLP compliance:
- yes
Test material
- Reference substance name:
- Cyclohex-3-ene-1-carbaldehyde
- EC Number:
- 202-858-3
- EC Name:
- Cyclohex-3-ene-1-carbaldehyde
- Cas Number:
- 100-50-5
- Molecular formula:
- C7H10O
- IUPAC Name:
- cyclohex-3-ene-1-carbaldehyde
- Details on test material:
- content 97.7 %
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- EST-1000 (Cell Systems, St. Katharinen, Germany)
- Source species:
- human
- Cell type:
- other: reconstructed 3D human epidermis
- Vehicle:
- unchanged (no vehicle)
- Amount/concentration applied:
- 50 µL
- Duration of treatment / exposure:
- incubation periods of 3 min and 60 min
- Duration of post-treatment incubation (if applicable):
- no post-treatment incubation period; 3 hours incubation with MRR solution
- Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 3 min treatment
- Value:
- 43.65
- Remarks on result:
- other: mean of 3 samples compared to negative control (NaCL, 0.9%, set to 100% viability)
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 60 min treatment
- Value:
- 5.25
- Remarks on result:
- other: mean of 3 samples compared to negative control (NaCL, 0.9%, set to 100% viability)
Any other information on results incl. tables
| Sample No | Test item | Time [min.] | OD mean* | StdDev | Viability % |
| 1 -3 | control NaCl 0.9% | 60 | 2.08 | 0.10 | 100 |
| 4 -6 | Tetrahydrobenzaldehyd | 60 | 0.11 | 0.01 | 5.25 |
| 13 -15 | control NaCl 0.9% | 3 | 3.0 | 0.10 | 100 |
| 16 -18 | Tetrahydobenzaldehyd | 3 | 1.31 | 0.35 | 43.65 |
* 6 values
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (corrosive) based on GHS criteria
- Conclusions:
- Tetrahydrobenzaldehyde was characterised by a significant impact on cell viability after 3 min. or after the 60 min. period.
Thus, it should be labelled as corrosive to skin. - Executive summary:
A study for predicting non-specific, corrosive potentials of compounds by using reconstructed human skin (RHS) was performed. The experiment was carried out on a reconstructed human epidermis EST-1000 (CellSystems, St. Katharinen, Germany) for detection of topically applied skin corrosives with the test item dibutyl hydrogen phosphate.
Corrosive skin effects of substances are defined as irreversible damage of skin; namely, visible necrosis through the epidermis and into the dermis, following the application of a test substance for up to four hours. In vivo corrosive reactions are typified by ulcers, bleeding, and bloody scabs.
A 100% concentration was tested on the skin/epidermal equivalents in triplets. For the determination of time related cytotoxic effects the incubation periods were 3 min. and 60 min., respectively. By this the study, was conducted in accordance with the OECD 431 guideline using the test item concentrations and incubation periods recommended there. These tests are also related to the revised OECD 404 guideline "Acute Dermal Irritation/Corrosion".
The test item was applied at a 100% concentration, i.e. 50µl per insert.
The MTT (Methylthiazoletetrazolium) method has determined the following values of viability after 3 min. or after 60 min. of incubation: 44% and 5% (rounded), respectively.
Thus, the results show that a corrosive property of the test item was determined by the assay used.
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.
