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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 201-612-2 | CAS number: 85-52-9
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation, other
- Type of information:
- calculation (if not (Q)SAR)
- Remarks:
- DEREK prediction
- Adequacy of study:
- key study
- Study period:
- 07 June 2018 to 15 June 2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- The objective of this study was to obtain a prediction on the potential for skin sensitization of the test item with the in silico model DEREK NEXUS. In this assessment version 6.0.1 of DEREK NEXUS was used.
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- - Chemical name: 2-Benzoylbenzoic acid
- CAS Number: 85-52-9 - Positive control results:
- Not applicable.
- Key result
- Parameter:
- other: Negative
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Remarks on result:
- no indication of skin sensitisation
- Other effects / acceptance of results:
- DEREK NEXUS version 6.0.1 did not yield any alerts for skin sensitization for the test item. Additionally, the query structure does not contain any unclassified or misclassified features and is consequently predicted to be a non-sensitizer.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study, the test material has been predicited to be a non-sensitizer.
- Executive summary:
A study to investigate the potential for the test item to be a skin sensitizer was conducted in accordance to recognised standards. An in-vitro software prediction was made using DEREK; the test material has been predicited to be a non-sensitizer.
- Endpoint:
- skin sensitisation: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- Principles of method if other than guideline:
- The principle is base on chemical reactivity of the test item with proteins.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- direct peptide reactivity assay (DPRA)
- Justification for non-LLNA method:
- The method used is an in chemico recognized method (OECD442C) that allows to predict sensitizeation potential of a test item.
- Details on the study design:
- The interaction between the molecule and lysine or cysteoine rich peptides is detected with HPLC. The depletion rates of lysine and cysteine peptides (after 24 hours of incubation) are used to distinguish the skin sensitizer and non-sensitizer.
- Positive control results:
- Yes : cinnamaldehyde 100mM
- Key result
- Run / experiment:
- mean
- Parameter:
- other: depletion of lysine %
- Value:
- 5.07
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- mean
- Parameter:
- other: Depletion in cysteine %
- Value:
- 1.32
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- All validity criteria are fullfilled wich allows to validate the study.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The sensitivity is determined according OECD 442C method. The study reports a mean depletion of 5.07% for lysine and 1.32% for cysteine, reflecting no or minimal reactivity and therefore a negative prediction.
- Executive summary:
The sensitivity is determined according OECD 442C method. The study reports a mean depletion of 5.07% for lysine and 1.32% for cysteine, reflecting no or minimal reactivity and therefore a negative prediction.
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- activation of keratinocytes
- Details on the study design:
- The test item was tested at 12 concentrations according to a geometric progression of ratio 2 from 0.98 µM to 2000µM.
- Positive control results:
- The positive control (cynnamaldehyde) is valid :
- Mean EC1.5 = 11.96
- Mean Imax = 6.13 - Key result
- Run / experiment:
- mean
- Parameter:
- other: Viability percentage
- Value:
- 70
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- mean
- Parameter:
- other: Induction - Imax
- Value:
- 20.1
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- mean
- Parameter:
- other: Induction - EC1.5 (µM)
- Value:
- 1 000
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Imax is higher than 1.5
EC1.5 is lower than 1000µM
At the EC1.5 concentration, the viability is higher than 70% - Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The skin sensitization was determined according to OECD 442D guideline. The obtained results show that the test item may be classified as potential skin sensitizer.
- Executive summary:
The skin sensitization was determined according to OECD 442D guideline. The obtained results show that the test item may be classified as potential skin sensitizer.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
1. A study to investigate the potential for the test item to be a skin sensitizer was conducted in accordance to recognised standards. An in-vitro software prediction was made using DEREK; the test material has been predicited to be a non-sensitizer.
2. The sensitivity was determined according OECD 442C method. The study reports a mean depletion of 5.07% for lysine and 1.32% for cysteine, reflecting no or minimal reactivity and therefore a negative prediction.
3.The skin sensitization was determined according to OECD 442D guideline. The obtained results show that the test item may be classified as potential skin sensitizer.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The obtained results show that the test item may be classified as potential skin sensitizer from the OECD 442D guideline.
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.
