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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 208-517-5 | CAS number: 531-75-9
- 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
Endpoint summary
Administrative data
Description of key information
An in vivo study was published in 2001 describing a test design equivalent to OECD Guideline 406 (Guinea Pig Maximisation Test)
The results for esculin were as follows:
0% sensitisation was observed at 0.01 M,
25% sensitistation rate was observed at 0.1 M
As the sensitistion rate is below 30% no classification is required according to CLP.
In addition an OECD Guideline 442D study was conducted (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method).
In the first and second experiments, no significant luciferase induction > 1.5 was found in the tested concentration range. Therefore, no EC1.5 value could be calculated. Under the condition of this study the test item is therefore considered as non sensitiser.
A second in vitro study (OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))) shows
Co-elution of esculin with the lysine peptide peak was observed and cannot be used for evaluation. A low reactivity towards the synthetic cystein peptides at 100 mM stock solution was observed. The mean depletion of the cysteine peptide was > 13.89% (14.09%) and is therefore in the borderline range.
Based on the results of the in vivo study we conclude that no classification according to CLP is required.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: publication
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- available reference with in vivo study
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Route:
- intradermal
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.1 M
- Day(s)/duration:
- 6
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- other: ethanol
- Concentration / amount:
- 0.1 M
- Day(s)/duration:
- 2
- Adequacy of challenge:
- not specified
- No.:
- #2
- Route:
- epicutaneous, open
- Vehicle:
- other: ethanol
- Concentration / amount:
- 0.01 M
- Day(s)/duration:
- 2
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 12
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1 M
- No. with + reactions:
- 3
- Total no. in group:
- 12
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.01 M
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 0% sensitisation was observed at 0.01M,
25% sensitistation rate was observed at 0.1 M
As the sensitistion rate is below 30% no classification is required according to CLP. - Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Mai 2018
- 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)
- Version / remarks:
- February 04, 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- activation of keratinocytes
- Key result
- Run / experiment:
- other: first experiment
- Parameter:
- other: luciferase induction
- Value:
- 1.5
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- other: second experiment
- Parameter:
- other: luciferase induction
- Value:
- 1.5
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Executive summary:
In the first and second experiments, nosignificant luciferase induction > 1.5 was found in the tested concentration range. Therefore, no EC1.5value could be calculated. Under the condition of this study the test item is therefore considered as non sensitiser.
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018
- 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))
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- direct peptide reactivity assay (DPRA)
- Specific details on test material used for the study:
- Dose Groups
Solvent control
Test Item: 100 mM stock solution
Positive Control: 100 mM stock solution - Key result
- Parameter:
- other: Mean Cysteine Peptide Depletion
- Remarks:
- in %
- Value:
- 14.09
- Positive controls validity:
- valid
- Key result
- Parameter:
- other: Mean Lysine Peptide Depletion
- Remarks:
- in %
- Value:
- 1.68
- Positive controls validity:
- valid
- Conclusions:
- In the present study Aesculin was dissolved in DMF. Based on a molecular weight of 367.31 g/mol a 100 mM stock solution was prepared.
For the 100 mM stock solution of the test item no turbidity or precipitation was observed when diluted with the cysteine peptide solution and lysine peptide solution.
Co-elution of the test item with the lysine peptide peak was observed. The peak area determined in the co-elution controls corresponds to 0.0185 mM of lysine peptide. Therefore, the given peak areas and corresponding lysine peptide values can only be considered as an estimation of the peptide depletion and cannot be used for evaluation.
The 100 mM stock solution of the test item showed low reactivity towards the synthetic peptides. The mean depletion of the cysteine peptide was > 13.89% (14.09%). Based on the prediction model 2 the test item can be considered as sensitiser.
The 100 mM stock solution of the positive control (cinnamic aldehyde) showed high reactivity towards the synthetic peptides. The mean depletion of both peptides was 65.32%. The controls confirmed the validity of the study for both, the cysteine and lysine run.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
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.