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EC number: - | CAS number: -
- 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
The test item may be classified as not a skin sensitizer using the LuSens test method but predicted as a sensitiser in the human Cell Line Activation Test (h-CLAT). The test results need to be considered in an overall weight of evidence assessment, i.e. as part of an integrated approach to testing and assessment (IATA). In order to have two out of three in vitro results DPRA would need to be conducted. However, the current DPRA prediction model cannot be used for complex mixtures of unknown composition or for substances of unknown or variable composition, complex reaction products or biological materials (i.e. UVCB substances) due to the defined molar ratio of test chemical and peptide. For this reason, read-across by grouping and read-across by analogue approach were used as part of the weight of evidence instead. The conclusion is that the substance is not predicted to be a skin sensitizer.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- See attached justification
- Reason / purpose for cross-reference:
- read-across source
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Remarks:
- positive control group not used - not necessary in human patch testing
- Reading:
- 1st reading
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Remarks:
- negative control group not used - not required for human patch testing
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 3 x week 9 aplications (10% as supplied) 0.5ml path
- No. with + reactions:
- 1
- Total no. in group:
- 6
- Clinical observations:
- barely perceptible or spotty erithema
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not a skin sensitizer.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: HRIPT(Human Repeat Insult Patch Testing)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Use repetitive epidermal contact to determine the potential of the title compound to induce primary or cumulative irritation and/or allergic contact sensitization.
- GLP compliance:
- no
- Type of study:
- patch test
- Justification for non-LLNA method:
- There is a weight of evidence from human patch testing so the need for animal testing was not deemed necessary.
- Species:
- human
- Sex:
- male/female
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 ml of the test material (SugaNate 160)
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 ml of the test material (SugaNate 160)
- No. of animals per dose:
- 6
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3 x week 9 aplications (10% SugaNate) 0.5ml path
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 3 x week 9 aplications (10% SugaNate) 0.5ml path. No with. + reactions: 0.0. Total no. in groups: 6.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 3 x week 9 aplications (10% SugaNate) 0.5ml path
- No. with + reactions:
- 1
- Total no. in group:
- 6
- Clinical observations:
- barely perceptible or spotty erithema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 3 x week 9 aplications (10% SugaNate) 0.5ml path. No with. + reactions: 1.0. Total no. in groups: 6.0. Clinical observations: barely perceptible or spotty erithema.
- Reading:
- 1st reading
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Remarks:
- negative control group not used - not required for human patch testing
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Remarks:
- positive control group not used - not necessary in human patch testing
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this study, test material Suga®Nate 160, lot # 19518D08, did not indicate a potential for dermal irritation or allergic contact sensitization.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- (Q)SAR
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Justification for type of information:
- The current DPRA prediction model cannot be used for complex mixtures of unknown composition or for substances of unknown or variable composition, complex reaction products or biological materials (i.e. UVCB substances) due to the defined molar ratio of test chemical and peptide. The QSAR Toolbox standardized workflow Skin Sensitization from GMPT Assay was used instead as part of the weight of evidence. Workflow principle attached.
- Qualifier:
- according to guideline
- Guideline:
- other: ECHA Guidance R.6
- GLP compliance:
- no
- Remarks:
- not applicable
- Specific details on test material used for the study:
- [Na+].[Na+].CCCCCCCCCCCCOC1OC(COCC(O)COC(=O)CC(O)(CC([O-])=O)C([O-])=O)C(O)C(O)C1O
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test chemical was predicted to be a non-sensitizer to skin based on a QSAR Toolbox Standard Workflow prediction.
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 22 February 2022 - 12 April 2022
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442E (In Vitro Skin Sensitisation assays addressing the key event on activation of dendritic cells on the Adverse Outcome Pathway for skin sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- human Cell Line Activation Test (h-CLAT)
- Details of test system:
- THP-1 cell line [442E]
- Vehicle / solvent control:
- cell culture medium
- Negative control:
- DL-Lactic acid
- Positive control:
- dinitrochlorobenzene (DNCB) [442E]
- Key result
- Group:
- test chemical
- Run / experiment:
- run/experiment 2
- Parameter:
- other: RFI CD54
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: The RFI of CD54 was ≥ 200 % in the two highest test item concentrations (320.09 μg/mL and 384.11 μg/mL). EC200: 306.49 μg/mL
- Key result
- Group:
- test chemical
- Run / experiment:
- run/experiment 1
- Parameter:
- other: RFI CD54
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: The RFI of CD54 was 200 % in the highest test item concentration of 384.11 μg/mL. EC200: 320.59 μg/mL
- Key result
- Group:
- test chemical
- Run / experiment:
- run/experiment 2
- Parameter:
- other: RFI CD86
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: RFI was lower than 150 % at all tested doses
- Key result
- Group:
- test chemical
- Run / experiment:
- run/experiment 1
- Parameter:
- other: RFI CD86
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: RFI was lower than 150 % at all tested doses
- Outcome of the prediction model:
- positive [in vitro/in chemico]
- Interpretation of results:
- other: Test result is considered in an overall weight of evidence assessment, i.e. as part of an integrated approach to testing and assessment (IATA) in accordance with OECD guideline 442E
- Conclusions:
- Under the conditions of the test, it can be concluded, that the test substance is predicted a sensitiser in the human Cell Line Activation Test (h-CLAT). The result does not allow for the non-classification or classification as skin sensitiser of the test substance and therefore further evaluation and/or data generation was performed.
- Executive summary:
Two valid runs with a treatment period of 24 hours were performed.
In the experiment, the highest nominal applied concentration (384.11 μg/mL) was chosen based on the results obtained in the pre-test. A geometric series (factor 1.2) of 7 dilutions thereof was prepared and tested. Precipitation of the test item was not visible in any of the runs.
As solvent control for the test item, RPMI 1640 was used in a final concentration of 1 % in culture medium.
As positive control, 2,4-dinitrochlorobenzene (DNCB, CAS n. 97-00-7, ≥ 99% purity) was used.In both runs the RFI of CD86 was not ≥ 150 % at any tested concentration with cell viability ≥ 50 %.
In run I: The RFI of CD54 was 200 % in the highest test item concentration of 384.11 μg/mL. EC200: 320.59 μg/mL
In run II: The RFI of CD54 was ≥ 200 % in the two highest test item concentrations (320.09 μg/mL and 384.11 μg/mL). EC200: 306.49 μg/mLIn conclusion, it can be stated that under the experimental conditions of this study, the test item was positive in the h-CLAT and is therefore considered to have the potential to activate dendritic cells and therefore to up-regulate the cell surface marker expression of THP-1 cells.
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 01 February 2022 - 28 April 2022
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 luciferase KeratinoSens™ test method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- ARE-Nrf2 luciferase LuSens test method
- Details of test system:
- Lusens transgenic cell line [442D]
- Vehicle / solvent control:
- cell culture medium
- Negative control:
- DL-Lactic acid
- Positive control:
- other: p-Phenylenediamine
- Key result
- Group:
- test chemical
- Run / experiment:
- other: run/experiment 4
- Parameter:
- Imax [442D]
- Value:
- 1.2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Group:
- test chemical
- Run / experiment:
- run/experiment 2
- Parameter:
- Imax [442D]
- Value:
- 1.4
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Outcome of the prediction model:
- negative [in vitro/in chemico]
- Interpretation of results:
- other: Test result is considered in an overall weight of evidence assessment, i.e. as part of an integrated approach to testing and assessment (IATA) in accordance with OECD guideline 442D.
- Conclusions:
- Under the experimental conditions the test item may be classified as not a skin sensitizer using the LuSens test method.
- Executive summary:
In the experiment (repetition II and IV), the highest nominal applied concentration (45.0 μg/mL in repetition II and 64.8 μg/mL in repetition IV) was chosen based on the results obtained in the CRFT and repetition II. A geometric series (factor 1.2) of eleven dilutions thereof was prepared. Precipitation of the test item was not visible in any of the repetitions.
DMEM (final concentration: 1 %) was used as solvent control and medium no. 3 as growth control. Lactic acid (5000 μM) was used as negative control and p-Phenylenediamine (60 μM) as positive control.No substantial and reproducible dose-dependent increase in luciferase induction equal or above 1.5 fold was observed in both valid repetitions up to the maximal tested concentration of the test item.
Under the experimental conditions of this study, the test item, Suga®Citrate L1C, was negative in the LuSens assay and is therefore considered not to have the potential to activate the Nrf2 transcription factor.
Referenceopen allclose all
In the experiment (repetition II and IV), the highest nominal applied concentration (45.0 μg/mL in repetition II and 64.8 μg/mL in repetition IV) was chosen based on the results obtained in the CRFT and repetition II. A geometric series (factor 1.2) of eleven dilutions thereof was prepared. Precipitation of the test item was not visible in any of the repetitions.
DMEM (final concentration: 1 %) was used as solvent control and medium no. 3 as growth control. Lactic acid (5000 μM) was used as negative control and p-Phenylenediamine (60 μM) as positive control.
No substantial and reproducible dose-dependent increase in luciferase induction equal or above 1.5 fold was observed in both valid repetitions up to the maximal tested concentration of the test item.
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.