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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 700-064-6 | CAS number: 2105830-60-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 431 (In vitro Skin Corrosion: Human Skin Model Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Esterification product of castor oil and tetrahydromethyl-1,3-isobenzofuranedione
- EC Number:
- 700-064-6
- Cas Number:
- 2105830-60-0
- Molecular formula:
- Not applicable as this is a UVCB substance
- IUPAC Name:
- Esterification product of castor oil and tetrahydromethyl-1,3-isobenzofuranedione
- Reference substance name:
- [TN]Multiester P97-463[/TN][SPEC][/SPEC][AM]100 %[/AM]
- IUPAC Name:
- [TN]Multiester P97-463[/TN][SPEC][/SPEC][AM]100 %[/AM]
- Details on test material:
- Multiester P97-463
Batch No.: NB2890-61
Constituent 1
Constituent 2
Test animals
- Species:
- other: Human Skin Model
- Strain:
- other: EpiDerm Skin Model
Test system
- Type of coverage:
- open
- Preparation of test site:
- other: not applicable
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 25 mg with 25 µl water
- Duration of treatment / exposure:
- 3 min and 1 hour
- Observation period:
- not applicable
- Number of animals:
- 0
- Details on study design:
- two tissues for a 3 min exposure
two tissues for a 1 h exposure
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Human Skin Model
- Basis:
- other: not applicable
- Time point:
- other: 3 min
- Score:
- 108
- Max. score:
- 108
- Reversibility:
- no data
- Remarks on result:
- other: The score is tissue viability as percentage of control
- Irritation parameter:
- other: Human Skin Model
- Basis:
- other: not applicable
- Time point:
- other: 1 h
- Score:
- 108
- Max. score:
- 108
- Reversibility:
- no data
- Remarks on result:
- other: The score is tissue viability as percentage of control
- Other effects:
- no other effects
Any other information on results incl. tables
Mean tissue viability in the in vitro skin corrosion test with Multiester P97-463
| 3 min application viability (percentage of control) | 1 hr application viability (percentage of control) | |
| Negative control | 100 | 100 |
| Multiester P97-463 | 108 | 108 |
| Positive control | 5 | 4 |
The Table shows the mean tissue viability obtained after 3 minutes and 1 hour treatment with Multiester P97-463 compared to the negative control tissues. Skin corrosion is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 3 minutes and 1 hour treatment with Multiester P97-463 compared to the negative control tissues was 108% at both exposure times. Since the mean relative tissue viability for Multiester P97-463 was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment Multiester P97-463 is considered to be not corrosive.
The absolute mean OD540 (optical density at 540 nm) of the negative control tissues was within the laboratory historical control data range. The mean relative tissue viability of the 3 minutes exposure of the positive control was 5%. The maximum inter tissue variability in viability between two tissues treated identically was less than 21% and the maximum difference in percentage between the mean viability of two tissues and one of the two tissues was less than 12%. It was therefore concluded that the test system functioned properly.
Applicant's summary and conclusion
- Interpretation of results:
- other: not corrosive
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Classification: not corrosive
- Executive summary:
It is concluded that this test is valid and that Multiester P97-463 is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.
This report describes the corrosive properties of Multiester P97-463 on a human threedimensional epidermal model (EpiDerm (EPI-200)). The possible corrosive potential of Multiester P97-463 was tested through topical application for 3 minutes and 1 hour. The study procedures described in this report were based on the most recent OECD and EC guidelines.
Batch NB2890-61 of Multiester P97-463 was a very viscous amber liquid. Since Multiester P97-463 was very viscous it was applied like a solid test substance. Approximately 25 mg Multiester P97-463 with 25 μl of Milli-Q water was applied directly on top of the skin tissue. The positive control had a mean relative tissue viability after 3 minutes exposure of 5%. The absolute mean OD540 (optical density at 540 nm) of the negative control tissues was within the laboratory historical control data range. The maximum inter tissue variability in viability between two tissues treated identically was less than 21% and the maximum difference in percentage between the mean viability of two tissues and one of the two tissues was less than 12%, indicating that the test system functioned properly. Skin corrosion is expressed as the remaining cell viability after exposure to the test substance.
The relative mean tissue viability obtained after 3 minutes and 1 hour treatment with Multiester P97-463 compared to the negative control tissues was 108% at both exposure times. Since the mean relative tissue viability for Multiester P97-463 was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment Multiester P97-463 is considered to be not corrosive.
Finally, it is concluded that this test is valid and that Multiester P97-463 is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.
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.
