Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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: 210-112-3 | CAS number: 606-28-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Methyl 2-benzoylbenzoate
- EC Number:
- 210-112-3
- EC Name:
- Methyl 2-benzoylbenzoate
- Cas Number:
- 606-28-0
- Molecular formula:
- C15H12O3
- IUPAC Name:
- methyl 2-benzoylbenzoate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): RCX 14-672
- Chemical name: methyl-2-benzoylbenzoate
- Substance type: organic
- Physical state: white to light yellowish powder
- Analytical purity: >99%
- Impurities (identity and concentrations): unknown
- Lot/batch No.: N14003
- Expiration date of the lot/batch: 30 November 2015
- Stability under test conditions: stable
- Storage condition of test material: controlled room temperature (15-25°C, below 70 RH%), protected from light and humidity
Constituent 1
- Specific details on test material used for the study:
- Identification: RCX 14-672
Chemical name: methyl-2-benzoylbenzoate
Batch no.: N14003
CAS no.: 606-28-0
EC no.: 210-112-3
Molecular formula: C15H12O3
Molecular mass: 240.3 g/mol
Description: white to light yellowish powder
Purity: >99% (gas chromatography)
Water solubility: 117.7 mg/l
Test item storage: at room temperature, protected from light
Stability: stable under storage conditions
Expiry date: 30 November 2015
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/J Rj mice
- Sex:
- female
- Details on test animals and environmental conditions:
- Species and strain: CBA/J Rj mice
Source: ELEVAGE JANVIER, Route des Chènes Secs B.P. 4105, 53940 LE GENEST-ST-ISLE, France
Number of animals:4 animals / treatment group
Sex: Female, nulliparous, non pregnant
Age of animals at starting: Young adults, 8-12 weeks old (age-matched, within one week)
Acclimatization time: at least 5 days
Cage type: Type II. polypropylene/ polycarbonate
Bedding: Bedding available to animals during the study
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 22 ± 3 °C
Relative humidity: 30 - 70 %
Ventilation: 15-20 air exchanges/hour
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 100, 50, 25 and 10 % (w/v)
- No. of animals per dose:
- Six animales per dose
- Details on study design:
- Based on the results of the Preliminary Compatibility Test and on the recommendations of the OECD Guideline 429 [1], the test item was tested for formulation compatibility in acetone:olive oil 4:1 (v:v) mixture (abbreviated as AOO). The highest achievable concentration was 100 % (w/v). The Preliminary Irritation / Toxicity Test I and II were performed in CBA/J Rj mice using four doses: 100, 50, 25 and 10 % (w/v) in AOO and the Preliminary Irritation / Toxicity Test III was performed in CBA/J Rj mice using two doses: 100 and 50 % (w/v) in AOO.
Based on the observations recorded in the preliminary test, the 100 % (w/v) was selected as top dose for the main test.
In the main assay, twenty-four female CBA/J Rj mice were allocated to six groups of four animals each:
- four groups received RCX 14-672 (formulated in AOO) at 100, 50, 25 and 10 % (w/v) concentrations,
- the negative control group received the vehicle (AOO),
- the positive control group received 25 % (w/v) HCA (dissolved in AOO).
The test item solutions were applied on the dorsal surface of ears of experimental animals (25 µl/ear) for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6. On Day 6, the cell proliferation in the local lymph nodes was measured by incorporation of tritiated methyl thymidine (3HTdR) and the values obtained were used to calculate stimulation indices (SI). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The result of the positive control substance hexylcinnamaldehyde (HCA) dissolved in the same vehicle was used to demonstrate the appropriate performance of the assay. The positive control substance was examined at a concentration of 25 % in the relevant vehicle (AOO) using CBA/J Rj mice. No mortality, cutaneous reactions or signs of toxicity were observed for the positive control substance in the study. A significant lymphoproliferative response (stimulation index value of 12.4) was noted for HCA in the main experiment. This value was considered to confirm the appropriate performance of the assay.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.7
- Test group / Remarks:
- 100% in acetone:olive oil (4:1)
- Key result
- Parameter:
- SI
- Value:
- 1.1
- Test group / Remarks:
- 50% in acetone:olive oil (4:1)
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 25% in acetone:olive oil (4:1)
- Key result
- Parameter:
- SI
- Value:
- 0.8
- Test group / Remarks:
- 10% in acetone:olive oil (4:1)
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- Acetone:olive oil (4:1), negavtive control
- Key result
- Parameter:
- SI
- Value:
- 12.6
- Test group / Remarks:
- hexylcinnamaldehyde (positive control)
Any other information on results incl. tables
No mortality or signs of systemic toxicity were observed during the study. Test item precipitate was observed on the ears of the experimental animals in the 100 % (w/v) dose group on Days 1-6, in the 50 % (w/v) group on Days 1-5 and in the 25 % (w/v) dose group on Days 1-3. Alopecia was observed in the 100 % (w/v) dose group on Days 2-6 and in the 50 % (w/v) group on Days 3-6.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Conclusions:
- Under the conditions of the present assay, RCX 14-672, tested in a suitable vehicle, did not show a sensitisation potential (non-sensitizer) in the Local Lymph Node Assay.
- Executive summary:
The aim of this study was to determine the skin sensitisation potential of RCX 14-672 following dermal exposure. The study was performed with vertebrate animals as no regulatory in vitro alternative is available. The minimum number of animals was used,
corresponding to the regulatory guidelines being followed. Based on the results of the Preliminary Compatibility Test and on the recommendations of the OECD Guideline 429 [1], the test item was tested for formulation compatibility in acetone:olive oil 4:1 (v:v) mixture (abbreviated as AOO). The highest achievable concentration was 100 % (w/v).
The Preliminary Irritation / Toxicity Test I and II were performed in CBA/J Rj mice using four doses: 100, 50, 25 and 10 % (w/v) in AOO and the Preliminary Irritation / Toxicity Test III was performed in CBA/J Rj mice using two doses: 100 and 50 % (w/v) in AOO. Based on the observations recorded in the preliminary test, the 100 % (w/v) was selected as top dose for the main test. In the main assay, twenty-four female CBA/J Rj mice were allocated to six groups of four animals each:
- four groups received RCX 14-672 (formulated in AOO) at 100, 50, 25 and 10 % (w/v) concentrations,
- the negative control group received the vehicle (AOO),
- the positive control group received 25 % (w/v) HCA (dissolved in AOO).
The test item solutions were applied on the dorsal surface of ears of experimental animals (25 μl/ear) for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6. On Day 6, the cell proliferation in the local lymph nodes was measured by incorporation of tritiated methyl thymidine (3HTdR) and the values obtained were used to calculate stimulation indices (SI). No mortality or systemic clinical signs were observed during the study. Test item precipitate was observed on the ears of the experimental animals in the 100 % (w/v) dose group on Days 1-6, in the 50 % (w/v) group on Days 1-5 and in the 25 % (w/v) dose group on Days 1-3. Alopecia was observed in the 100 % (w/v) dose group on Days 2-6 and in the 50 % (w/v) group on Days 3-6. The observed stimulation index values were 1.7, 1.1, 1.0 and 0.8 at concentrations of 100, 50, 25 and 10 % (w/v), respectively. The result of the positive control substance a-Hexylcinnamaldehyde (HCA) dissolved in the same vehicle was used to demonstrate the appropriate performance of the assay [1]. A significant lymphoproliferative response (stimulation index value of 12.4) was noted for the positive control chemical, this result confirmed the validity of the assay.
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.