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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 211-238-1 | CAS number: 635-51-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018-03-02 - 2018-03-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 430 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Phenylsuccinic acid
- EC Number:
- 211-238-1
- EC Name:
- Phenylsuccinic acid
- Cas Number:
- 635-51-8
- Molecular formula:
- C10H10O4
- IUPAC Name:
- 2-phenylbutanedioic acid
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Molecular formula:
C10H10O4
Molecular Mass:
194.18
Characteristics (Physical Appearance):
White crystalline powder
Characteristics (Physical Appearance):
White Crystalline powder
CAS No.:
635-51-8
Batch Number:
123
Purity:
100%
In vitro test system
- Test system:
- isolated skin discs
- Source species:
- rat
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from multiple donors
- Source strain:
- Wistar
- Details on animal used as source of test system:
- Species:
Rat (Rattus norvegicus)
Strain:
Wistar
Justification of selection:
Rat is the rodent species and Wistar is the strain recommended by the test guideline.
Source:
Bred and reared at INTOX PVT. LTD.
Age at start of study:
22 days
No. of animals and sex:
10 males
Environmental conditions:
The experimental animal room was supplied with fresh and filtered air, with 10 to 15 air changes per hour. The room was air conditioned with temperature between 19 to 25 oC, relative humidity 30 to 70% and illumination cycle set to 12 hours light and 12 hours dark. - Vehicle:
- water
- Control samples:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount/concentration applied:
- 150 mg + 150 μL Analytical Grade Water
- Duration of treatment / exposure:
- 24 hours
- Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- transcutaneous electrical resistance (in kΩ)
- Run / experiment:
- test item
- Value:
- 12.87
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- transcutaneous electrical resistance (in kΩ)
- Run / experiment:
- solvent control
- Value:
- 15.83
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- transcutaneous electrical resistance (in kΩ)
- Run / experiment:
- positive control
- Value:
- 0.78
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the criteria of acceptance, under the experimental conditions of the study 'In-Vitro Skin Corrosion Study by Transcutaneous Electrical Resistance Test Method (TER) of 2-Phenylsuccinic Acid it is concluded that the test item 2-Phenylsuccinic Acid is considered as non-corrosive to rat skin as per the United Nations(UN) Globally Harmonised System (GHS) for classification of chemicals.
- Executive summary:
In-Vitro Skin Corrosion Study by Transcutaneous Electrical Resistance Test Method (TER) of 2-Phenylsuccinic Acid was carried out in compliance with the Organization for Economic Co-operation and Development (OECD) Guidelines for Testing of Chemicals, Section 4, No. 430 - In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER), adopted by the council on 26 July 2013.
The mean TER value obtained for test item 2-Phenylsuccinic Acid was 12.87 K Ω (which was greater than 5 k Ω) and the skin discs showed no obvious damage (e.g. perforation). The mean disc dye content was 55.14 μg/disc, which was lesser than the mean disc dye content of the 10M HCl positive control obtained concurrently.
According to the criteria of acceptance, under the experimental conditions of the study 'In-Vitro Skin Corrosion Study by Transcutaneous Electrical Resistance Test Method (TER) of 2-Phenylsuccinic Acid it is concluded that the test item 2-Phenylsuccinic Acid is considered as non-corrosive to rat skin as per the United Nations(UN) Globally Harmonised System (GHS) for classification of chemicals.
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.
