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Diss Factsheets
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EC number: 620-582-5 | CAS number: 301341-58-2
- 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
In a study performed to OECD Guideline 429 with GLP compliance, female mice were exposed topically on the dorsum of both ears to the test item at concentrations of 1%, 10% and 25% in acetone/olive oil (AOO) for three consecutive days.Control mice were treated with AOO (vehicle control) or with the reference item hexyl cinnamic aldehyde (HCA) in AOO (positive control) at concentrations of 10% and 30%. Mice were sacrificed after three days, small pieces were stamped from each ear, and weighed. The draining lymph nodes were excised, weighed, and single cell suspensions were prepared. Cell counts of the lymph node cell suspensions were measured, and based on significant responses in ear swelling and increases in lymph node cell counts a differentiation index (DI) was calculated for test item and reference item. The DI describes the relation between skin-draining lymph node cell activation (lymph node cell count index) and skin inflammation (ear weight index), with a DI > 1 indicating a chemically induced allergic reaction (skin sensitization), whereas 0 < DI < 1 demonstrates an irritant potency of the tested substance.
HCA as reference item and dosed at 10% and 30% showed significant increases in lymph node weights and lymph node cell counts in comparison to vehicle controls and thus was tested as skin sensitizing (DI > 1). The test item showed no increase at concentrations of 1% and 25%, but significant increases of cell counts and lymph node weights at a concentration of 10%. At 1% and 25% the DI was < 1, and 1.9 at 10%, which was mainly due to the response of one animal. Nevertheless, the DI was not as obviously increased as observed for the reference item and not confirmed at 1% and 25%. According to the OECD Guideline 429, other aspects such as the strength of the dose-response and the positive control responses may also be used when determining whether a borderline result is declared positive. In particular the proliferation of cells in the lymph node is considered to be proportional to the dose and to the potency of the applied allergen.
In conclusion, as there was no dose-response the test item should is not assessed to be a skin sensitizer.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation, other
- Remarks:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013
- 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)
- 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:
- Lot no: 110825
Date of Expiration: 25.08.2014
Appearance: white powder - Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
- Details on test animals and environmental conditions:
- strain: Balb/c:AnCrl
- Vehicle:
- other: acetone/olive oil (5:1 v/v)
- Concentration:
- 1, 10 or 25%
- No. of animals per dose:
- 6
- Details on study design:
- The original LLNA is based on the use of radioactive labelling for the measurement of cell proliferation, however other endpoints for the assessment of proliferation are also authorized by the OECD guideline 429. The non-radioactive method is an alternative and was validated in European inter-laboratory validation studies under the participation of Fraunhofer ITEM. One important aspect of the validation process of the alternative non-radioactive cell counting was comparing the sensitivity of the radioactive and non-radioactive method. All results found to be positive by the cell count method were also found to be positive by the radioactive assay, i.e. the modified LLNA is reliable and discriminates between sensitizing and irritating properties of a test item. Therefore, it avoids false positive results of the radioactive LLNA by including the measurement of acute skin reaction as an additional parameter for irritating properties of a test item and this modified method is considered to be suitable for regulatory purposes.
In this study groups of young adult female mice (Balb/c:AnCr l) were exposed topically on the dorsum of both ears to 25 uL of test item, reference item, or vehicle. Treatment was performed daily for 3 consecutive days.
The highest concentration of 50 % could not be applied as scheduled as it was not possible to suspense the appropriate amount of test item.
The mice were killed on day 4 and small pieces were stamped from each ear and weighed. The draining lymph nodes were excised and pooled for each animal. The lymph nodes were weighed and a single cell suspension was prepared by mechanical disaggregation. Cell counts were measured. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- yes
- Positive control results:
- HCA was confirmed as a skin sensitiser.
- Key result
- Parameter:
- other: differentiation index (see below)
- Remarks on result:
- other: see below
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item showed no increase at concentrations of 1% and 25%, but a significant increase of cells counts and lymph node weights at a concentration of 10%. The DI was < 1 at 1% and 25% and 1.9 at 10%, which was mainly due to the response of one animal. Thus, the DI was not as clearly increased as observed for the reference item and not confirmed at 1% and/or 25% tested dose. In conclusion, as there was no dose-response the test item should is not assessed to be a skin sensitizer.
- Executive summary:
In a study performed to OECD Guideline 429 with GLP compliance, female mice were exposed topically on the dorsum of both ears to the test item at concentrations of 1%, 10% and 25% in acetone/olive oil (AOO) for three consecutive days.Control mice were treated with AOO (vehicle control) or with the reference item hexyl cinnamic aldehyde (HCA) in AOO (positive control) at concentrations of 10% and 30%. Mice were sacrificed after three days, small pieces were stamped from each ear, and weighed. The draining lymph nodes were excised, weighed, and single cell suspensions were prepared. Cell counts of the lymph node cell suspensions were measured, and based on significant responses in ear swelling and increases in lymph node cell counts a differentiation index (DI) was calculated for test item and reference item. The DI describes the relation between skin-draining lymph node cell activation (lymph node cell count index) and skin inflammation (ear weight index), with a DI > 1 indicating a chemically induced allergic reaction (skin sensitization), whereas 0 < DI < 1 demonstrates an irritant potency of the tested substance.
HCA as reference item and dosed at 10% and 30% showed significant increases in lymph node weights and lymph node cell counts in comparison to vehicle controls and thus was tested as skin sensitizing (DI > 1).
The test item showed no increase at concentrations of 1% and 25%, but significant increases of cell counts and lymph node weights at a concentration of 10%. At 1% and 25% the DI was < 1, and 1.9 at 10%, which was mainly due to the response of one animal. Nevertheless, the DI was not as obviously increased as observed for the reference item and not confirmed at 1% and 25%. According to the OECD Guideline 429, other aspects such as the strength of the dose-response and the positive control responses may also be used when determining whether a borderline result is declared positive. In particular the proliferation of cells in the lymph node is considered to be proportional to the dose and to the potency of the applied allergen.
In conclusion, as there was no dose-response the test item should is not assessed to be a skin sensitizer.
Reference
In this study the differentiation index (DI) was determined, which describes the relation between skin-draining lymph node cell activation and skin inflammation:
DI > 1 indicates a chemically induced skin sensitization
0 < DI < 1 demonstrates an irritant potency of the test item.
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
In a GLP study according to OECD Guideline 429 in mice there was no indication for a significant skin sensitizing potential. Therefore, there is no need for classification and labelling of the test item according to CLP Regulation 1272/2008/EG.
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.
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