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EC number: 500-429-8 | CAS number: 159034-96-5
- 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
In Vitro:
In silico assessment of test item is considered not applicable due to the complexity of encoding this UVCB substance. The OECD 442C in chemico Direct Peptide Reactivity Assay is not applicable for addressing Key Event 1 of the skin sensitization Adverse Outcome Pathway (AOP) for complex UVCB substances. Furthermore, the two in vitro test guidelines that have been proposed for addressing Key Events 2 and 3 of the AOP , OECD 442D and OECD 442E, are considered not applicable to test item due to the poor solubility of the substance in water and organic solvents, the complex nature of the UVCB, differing estimated log Pow values, unknown toxicities of the individual constituents and their ability to interfere with the test systems. Hence negative results in these in vitro tests could not be used with confidence in an assessment of skin sensitization potential, whereas inconclusive or positive results would require testing in vivo in order to conclude on classification of the substance. Therefore, in consideration of the various points highlighted regarding non-applicability of the in silico methods, and in chemico and in vitro tests for assessment of test item, it is not possible to form a conclusion on classification of the substance without conduct of an in vivo study, this being an OECD 429 Local lymph node assay (LLNA) as required by REACH.
LLNA:
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 based on OECD 429.
Three groups, each of four animals, were treated with 50 μL (25 μL per ear)of the test item as a suspension in proplyene glycol at concentrations of 10% 5% or 2.5% w/w. A further group of four animals was treated with proplyene glycol alone.
The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are 1.71, 2.00, 2.93 for concentrations of 10%, 5% or 2.5% w/w, respectively.
The test item was considered to be a non-sensitizer under the conditions of the test as no concentration of the test item resulted in a threefold or greater increase in 3HTdR incorporation compared to control values.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 February 2018 - 27 February 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- EC No. 440/2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- Batch Number: 161129
Purity: 100%
Appearance: pale brown powder
Expiry Date: 28 November 2018 - Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- Female CBA/Ca (CBA/CaOlaHsd) strain mice were supplied by Envigo RMS B.V., Inc., Horst, The Netherlands. On receipt the animals were randomly allocated to cages. The animals were nulliparous and non pregnant. After an acclimatization period of at least 5 days the animals were selected at random and given a number unique within the study by indelible ink marking on the tail and a number written on a cage card. At the start of the study the animals were in the weight range of 15 to 23 g, and were 8 to 12 weeks old.
The animals were housed in suspended solid floor polypropylene cages furnished with softwood woodflakes. Free access to mains tap water and food (2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon, UK) was allowed throughout the study.
The temperature and relative humidity were set to achieve limits of 19 to 25 ℃ and 30 to 70%, respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness. - Vehicle:
- propylene glycol
- Concentration:
- 10%, 5% or 2.5% w/w in proplyene glycol
- No. of animals per dose:
- four
- Details on study design:
- As no toxicological information was available regarding the systemic toxicity/irritancy potential of the test item, a preliminary screening test was performed using mice, one mouse per test item concentration. The mice were treated by daily application of 25 µL of the test item at concentrations of 25 or 10% w/w in proplyene glycol, to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The mice were observed twice daily on Days 1, 2 and 3 and once daily on Days 4, 5 and 6. Local skin irritation was scored daily. Any clinical signs of toxicity, if present, were also recorded. The body weight of each mouse was recorded on Day 1 (prior to dosing) and on Day 6.
MAIN STUDY
Groups of four mice were treated with the test item at concentrations of 10%, 5% or 2.5% w/w in proplyene glycol. The preliminary screening test suggested that the test item would not produce systemic toxicity or excessive local skin irritation at the highest suitable concentration. The mice were treated by daily application of 25 µL of the appropriate concentration of the test item to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The test item formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette.
A further group of four mice received the vehicle alone in the same manner. - Statistics:
- not specified
- Positive control results:
- not specified
- Key result
- Parameter:
- SI
- Value:
- 1.71
- Variability:
- not specified
- Test group / Remarks:
- 2.5 (%w/w)
- Remarks on result:
- no indication of skin sensitisation based on QSAR/QSPR prediction
- Key result
- Parameter:
- SI
- Value:
- 2
- Variability:
- not specified
- Test group / Remarks:
- 5 (%w/w)
- Remarks on result:
- no indication of skin sensitisation based on QSAR/QSPR prediction
- Key result
- Parameter:
- SI
- Value:
- 2.93
- Variability:
- not specified
- Test group / Remarks:
- 10 (%w/w)
- Remarks on result:
- no indication of skin sensitisation based on QSAR/QSPR prediction
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was considered to be a non-sensitizer under the conditions of the test as no concentration of the test item resulted in a threefold or greater increase in 3HTdR incorporation compared to control values.
- Executive summary:
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 based on OECD 429.
Three groups, each of four animals, were treated with 50 μL (25 μL per ear)of the test item as a suspension in proplyene glycol at concentrations of 10% 5% or 2.5% w/w. A further group of four animals was treated with proplyene glycol alone.
The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are 1.71, 2.00, 2.93 for concentrations of 10% 5% or 2.5% w/w, respectively.
The test item was considered to be a non-sensitizer under the conditions of the test as no concentration of the test item resulted in a threefold or greater increase in 3HTdR incorporation compared to control values.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because the available in vitro test methods are not applicable for the substance and therefore an in vivo skin sensitisation study was conducted
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In silico assessment of test item is considered not applicable due to the complexity of encoding this UVCB substance. The OECD 442C in chemico Direct Peptide Reactivity Assay is not applicable for addressing Key Event 1 of the skin sensitization Adverse Outcome Pathway (AOP) for complex UVCB substances. Furthermore, the two in vitro test guidelines that have been proposed for addressing Key Events 2 and 3 of the AOP, OECD 442D and OECD 442E, are considered not applicable to test item due to the poor solubility of the substance in water and organic solvents, the complex nature of the UVCB, differing estimated log Pow values, unknown toxicities of the individual constituents and their ability to interfere with the test systems. Hence negative results in these in vitro tests could not be used with confidence in an assessment of skin sensitization potential, whereas inconclusive or positive results would require testing in vivo in order to conclude on classification of the substance. Therefore, in consideration of the various points highlighted regarding non-applicability of the in silico methods, and in chemico and in vitro tests for assessment of test item, it is not possible to form a conclusion on classification of the substance without conduct of an in vivo study, this being an OECD 429 Local lymph node assay (LLNA) as required by REACH.
Referenceopen allclose all
Body weight change of the test animals between Day 1 and Day 6 was comparable to that observed in the corresponding control group animals over the same period.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Skin sensitisation:
in vivo: LLNA, SI max: 2.93< 3, not sensitising
in vitro: waived as the available in vitro test methods are not applicable for the substance
Respiratory sensitisation:
No data available, not minimum required data.
Classification:
Skin: The stimulation indexes were below 3 in all tested concentrations in the murine local lymph node assay (OECD 429). Based on criteria from Regulation (EC) 1272/2008 and amendments, the substance does not have to be classified as a skin sensitiser.
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