Registration Dossier
Registration Dossier
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EC number: 231-293-5 | CAS number: 7486-38-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- Principles of method if other than guideline:
- This study for predicting non-specific, corrosive potentials of compounds by using reconstructed human skin (RHS) was performed in 2011. The experiment was carried out on a reconstructed human epidermis EST-1000 (CellSystems, Troisdorf, Germany) for detection of topically applied skin corrosives with the test item
Disodium adipate.
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 as well as with an EC guideline (amending Council Directive 67/548/EEC, B.40 Skin corrosion) 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".
To check the reliability of this test procedure a blinded positive/negative control study is conducted at regular intervals in the lab. This reliability check is always performed by two technicians, two laboratories in parallel using the same batches of the control test items. - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Disodium adipate
- EC Number:
- 231-293-5
- EC Name:
- Disodium adipate
- Cas Number:
- 7486-38-6
- Molecular formula:
- C6H10O4.2Na
- IUPAC Name:
- hexanedioic acid
- Test material form:
- other: powder
- Details on test material:
- Content: 97-100%
Constituent 1
Test animals
- Species:
- other: reconstructed human skin (RHS)
- Strain:
- other: reconstructed human skin (RHS)
Test system
- Type of coverage:
- other: reconstructed human skin (RHS)
- Preparation of test site:
- other:
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: To check the reliability of this test procedure a blinded positive/negative control study is conducted at regular intervals in the lab.
- Duration of treatment / exposure:
- 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.
- Observation period:
- 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.
- Number of animals:
- triplicates
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: viability
- Basis:
- mean
- Time point:
- other: 3 min
- Score:
- 102
- Remarks on result:
- other: viability in %
- Irritation parameter:
- other: viability
- Basis:
- mean
- Time point:
- other: 60
- Score:
- 101
- Remarks on result:
- other: viability in %
Any other information on results incl. tables
The MTT (Methylthiazoletetrazolium) method has determined the following values of viability after 3 min. or after 60 min. of incubation: 102% and 101%, (rounded) respectively. Thus, the results show that no corrosive property of the test item was determined by the assay used.
Applicant's summary and conclusion
- Conclusions:
- No corrosive property of the test item was determined by the assay used.
- Executive summary:
The MTT (Methylthiazoletetrazolium) method has determined the following values of viability after 3 min. or after 60 min. of incubation: 102% and 101%, (rounded) respectively. Thus, the results show that no corrosive property of the test item was determined by the assay used.
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