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Diss Factsheets
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EC number: 941-129-0 | CAS number: 1407974-32-6
- 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
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Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation
- Remarks:
- other: in vitro DPRA
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 February 2014 to 19 February 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted according to draft OECD test guideline.
- Qualifier:
- according to guideline
- Guideline:
- other: Draft OECD 13Nov2013
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- other: DPRA
- Positive control results:
- The positive control substance induced a mean depletion rate of 60.47%.
- Key result
- Run / experiment:
- mean
- Parameter:
- other: Cysteine peptide depletion
- Value:
- 0
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Run / experiment:
- mean
- Parameter:
- other: Lysine peptide depletion
- Value:
- 0
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: other:
- Conclusions:
- Under the experimental conditions of this study, the test item, has 0% peptide reactivity.
- Executive summary:
Introduction
The objective of the Direct Peptide Reactivity Assay (DPRA) was to evaluate the reactivity of the test item to synthetic cysteine and lysine peptides for skin sensitization assessment.
Methods
The reactivity of the test item was evaluated in chemico by monitoring peptide depletion following a 24-hour contact between the test item and synthetic cysteine and lysine peptides. The method consisted of the incubation of a diluted solution of cysteine or lysine with the test item for 24 hours. At the end of the incubation, the concentrations of residual peptides were evaluated by HPLC with Ultra-Violet detection at 220 nm. Peptide reactivity was reported as percent depletion based on the amount of peptide remaining in the sample relative to the average amount measured in the relevant reference control.
Results
Solubility assay
The test item was found soluble at 50 mg/mL in water obtained by reverse osmosis. Therefore, water obtained by reverse osmosis was selected as vehicle.
Direct Peptide Reactivity Assay
The acceptance criteria for the calibration curve samples, the reference and positive controls as well as for the study samples were satisfied. The study was therefore considered to be valid. Analysis of the chromatograms of the co-elution samples indicated that the test item did not co-elute with either the lysine or the cysteine peptides. As a result, the mean percent depletion values were calculated. For both cysteine and lysine peptides, the mean depletion values were set to 0% since the individual percent depletion values were negative. The mean of the percent cysteine and percent lysine depletions was therefore 0%. Accordingly, the test item was considered to have no/minimal peptide reactivity.
Conclusion
Under the experimental conditions of this study, the test item, has 0% peptide reactivity
Reference
Acceptance criteria were as per the draft OECD guideline.
Classification criteria for direct peptide reactivity were as per the draft OECD guideline.
Results for the test item and the positive control are presented in attached Tables 1 and 2, respectively. The peak areas for calibration curve samples are presented in attached Tables 3.1 and 3.2, the peptide concentrations and peak areas in reference control samples are presented in attached Tables 4.1 and 4.2. Representative chromatograms of the co-elution, reference control C and test item samples are presented for each peptide in attached Figures 1 to 6. The acceptance criteria for the calibration curve samples, the reference and positive controls as well as for the study samples were satisfied. The study was therefore considered to be valid. Analysis of the chromatograms of the co-elution samples (Figures 1 and 4) indicated that the test item did not co-elute with either the lysine or the cysteine peptides. As a result, the mean percent depletion values were calculated for each peptide using the formula described in § Data analysis and calculation. For both cysteine and lysine peptides, the mean depletion values were set to 0% since the individual percent depletion values were negative. The mean of the percent cysteine and percentage lysine depletions was therefore equal to 0%. Accordingly, the test item was considered to have no/minimal peptide reactivity.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Key In vitro Direct Peptide Reactivity Assay (DPRA)
Introduction
The objective of the Direct Peptide Reactivity Assay (DPRA) was to evaluate the reactivity of the test item to synthetic cysteine and lysine peptides for skin sensitization assessment.
Methods
The reactivity of the test item was evaluated in chemico by monitoring peptide depletion following a 24-hour contact between the test item and synthetic cysteine and lysine peptides. The method consisted of the incubation of a diluted solution of cysteine or lysine with the test item for 24 hours. At the end of the incubation, the concentrations of residual peptides were evaluated by HPLC with Ultra-Violet detection at 220 nm. Peptide reactivity was reported as percent depletion based on the amount of peptide remaining in the sample relative to the average amount measured in the relevant reference control.
Results
Solubility assay
The test item was found soluble at 50 mg/mL in water obtained by reverse osmosis. Therefore, water obtained by reverse osmosis was selected as vehicle.
Direct Peptide Reactivity Assay
The acceptance criteria for the calibration curve samples, the reference and positive controls as well as for the study samples were satisfied. The study was therefore considered to be valid. Analysis of the chromatograms of the co-elution samples indicated that the test item did not co-elute with either the lysine or the cysteine peptides. As a result, the mean percent depletion values were calculated. For both cysteine and lysine peptides, the mean depletion values were set to 0% since the individual percent depletion values were negative. The mean of the percent cysteine and percent lysine depletions was therefore 0%. Accordingly, the test item was considered to have no/minimal peptide reactivity.
Conclusion
Under the experimental conditions of this study, the test item, has 0% peptide reactivity
Disregarded In vivo LLNA Study
Introduction
A study was performed to assess the skin sensitization potential of the test item in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear.
Methods
In order to study the possible contact allergenic potential of the test substance, three groups of five female mice each were treated daily with the test item at concentrations of 25%, 50% and 75% (w/v) in acetonerolive oil (4:1 v/v) by topical application to the dorsum of each ear lobe for three consecutive days. A control group of five female mice was treated with the vehicle acetone:olive oil (4:1 v/v) only. A concurrent positive control group of five mice was treated with 25% (w/v) alpha-hexylcinnamaldehyde in acetone:olive oil (4:1 v/v). Five days after the first topical application the mice were injected intravenously into a tail vein with radio-labelled thymidine ( 3 H-methyl thymidine, 3HTdR). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes were excised and pooled per animal. For each animal, single cell suspensions of lymph node cells were prepared and subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3HTdR measured in a p-scintillation counter.
Results
All treated animals survived the scheduled study period. Neither clinical signs on the ears of the animals nor systemic findings were observed during the study period. The results obtained [Stimulation Index (S.I.)] are reported in the following table. The estimated concentration of test item required to produce a S.I. of 3 is referred to as the EC3 value.:
Treatment Group
Concentration
Stimulation Index
Result
Test Item
25% w/w in
acetone/olive oil (4:1 v/v)2.6
Negative
10% w/w in
acetone/olive oil (4:1 v/v)7.2
Positive
50% w/w in
acetone/olive oil (4:1 v/v)6.6
Positive
Positive
Control Item75% v/v in
acetone/olive oil (4:1 v/v)
8.9
Positive
The concentration of test item expected to cause a 3 fold increase in 3 HTdR incorporation (EC 3 value) was calculated to be 27.2%.
Conclusion
In conclusion, the test item was found to produce an EC3 value of 27.2% (w/v) and was considered to be a potential skin sensitizer under the conditions of the test.
Migrated from Short description of key information:
Although a GLP study, classified as K1, using the OECD 429 mouse lymph node assay (LLNA) performed on the test substance after formulation in acetone/olive oil (4:1, v/v) at 25, 50 and 75% w/w. indicated that the substance was potentially sensitising, a confirmation Direct Peptide Reactivity Assay (DPRA) showed that the substance has a 0% peptide reactivity. The substance is therefore not a skin sensitiser.
Justification for selection of skin sensitisation endpoint:
A GLP study classified as K1, using the draft OECD Direct Peptide Reactivity Assay (DRPA) test guideline provided a negative (non peptide reactive and therefore unlikely to be a skin sensitizer) result
A GLP study, classified as K3, using the OECD 429 mouse lymph node assay (LLNA) provided a positive (sensitizing) conclusion. However, the study was disregarded because it is not reliable for this class of chemical.
Justification for classification or non-classification
Although a GLP study, classified as K1, using the OECD 429 mouse lymph node assay (LLNA) performed on the test substance after formulation in acetone/olive oil (4:1, v/v) at 25, 50 and 75% w/w indicated that the substance was potentially sensitising, a confirmation Direct Peptide Reactivity Assay (DPRA) showed that the substance has a 0% peptide reactivity. The substance is therefore not a skin sensitiser.
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.
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