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Diss Factsheets
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EC number: 212-603-8 | CAS number: 831-52-7
- 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
The dermal sensitization potential of the test chemical was assessed in mice according to LLNA method. The study was conducted as per OECD Guidelines 429.
The Stimulations Indices[SI] were 1.2, 2.7, 3.6, 7.9 and 11.4 for the concentrations 1%,5%,10%,25%, 50% respectively.
The calculated EC3 value for the test chemical was 6.7% w/v and 12.96% for the positive control, α- hexylcinnamaldehyde.
Based on the above findings the test chemical can be considered to be sensitizing to skin.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Principles of method if other than guideline:
- To determine the dermal sensitization potential of the test chemical in mice according to LLNA method
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- mice, CBA/CaOlaHsd (nulliparous and non-pregnant)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 0, 1, 5, 10, 25 and 50% w/v
- No. of animals per dose:
- 24 females (4 per group)
- Details on study design:
- Sodium picramate (1%,
5%, 10%, 25%, or 50% test chemical in DMSO) was applied to both ears of the mice (n ¼ 4) for 3 consecutive days. The control group was administered the vehicle only. Two days after the last application,
the mice were injected with radiolabeled thymidine (methyl-3H-thymidine). The mice were killed approximately 5 hours after the injection, and the draining auricular lymph nodes were excised and pooled per group. The concentration of the radiolabel was measured.
EC3 is the estimated concentration of a chemical necessary to cause a 3-fold increase in lymph node cell proliferative activity. Chemicals that at 1 or more test concentrations provoke a 3-fold or greater in lymphnode cell proliferation compared with vehicle controls are classified as potential contact allergens. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- EC3 is the estimated concentration of a chemical necessary to cause a 3-fold increase in lymph node cell proliferative activity. Chemicals that at 1 or more test concentrations provoke a 3-fold or greater in lymphnode cell proliferation compared with vehicle controls are classified as potential contact allergens.
- Positive control results:
- The calculated EC3 value for the test chemical was 6.7% w/v. For the positive control, α- hexylcinnamaldehyde was 12.96%.
- Key result
- Parameter:
- EC3
- Value:
- 6.7
- Test group / Remarks:
- test group
- Remarks on result:
- other: positive sensitizer
- Cellular proliferation data / Observations:
- The Stimulations Indices[SI] were 1.2, 2.7, 3.6, 7.9 and 11.4 for the concentrations 1%,5%,10%,25%, 50% respectively.
The calculated EC3 value for the test chemical was 6.7% w/v - Interpretation of results:
- other: sensitizing
- Conclusions:
- The Stimulations Indices[SI] were 1.2, 2.7, 3.6, 7.9 and 11.4 for the concentrations 1%,5%,10%,25%, 50% respectively.
The calculated EC3 value for the test chemical was 6.7% w/v. For the positive control, α- hexylcinnamaldehyde was 12.96%.
Based on the above findings the test chemical can be considered to be sensitiziing to skin. - Executive summary:
The dermal sensitization potential of the test chemical was assessed in mice according to LLNA method. The study was conducted as per OECD Guidelines 429.
5%, 10%, 25%, or 50% test chemical in DMSO) was applied to both ears of female non pregnant, nulliparous CBA/CaOlaHsd mice (n= 4) for 3 consecutive days. The control group was administered the vehicle only. Two days after the last application, the mice were injected with radiolabeled thymidine (methyl-3H-thymidine). The mice were killed approximately 5 hours after the injection, and the draining auricular lymph nodes were excised and pooled per group. The concentration of the radiolabel was measured.
EC3 is the estimated concentration of a chemical necessary to cause a 3 -fold increase in lymph node cell proliferative activity. Chemicals that at 1 or more test concentrations provoke a 3-fold or greater in lymphnode cell proliferation compared with vehicle controls are classified as potential contact allergens.
The Stimulations Indices[SI] were 1.2, 2.7, 3.6, 7.9 and 11.4 for the concentrations 1%,5%,10%,25%, 50% respectively.
The calculated EC3 value for the test chemical was 6.7% w/v and 12.96% for the positive control, α- hexylcinnamaldehyde.
Based on the above findings the test chemical can be considered to be sensitiziing to skin.
Reference
Results of the LLNA study
Concentration |
Stimulation Index |
Test item |
|
1% |
1.2 |
5% |
2.7 |
10% |
3.6 |
25% |
7.9 |
50% |
11.4 |
Alpha-hexylcinnamaldehyde |
|
5% |
0.87 |
10% |
2.26 |
25% |
6.01 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Skin Sensitization
The dermal sensitization potential of the test chemical was assessed in mice according to LLNA method. The study was conducted as per OECD Guidelines 429.
5%, 10%, 25%, or 50% test chemical in DMSO) was applied to both ears of female non pregnant, nulliparous CBA/CaOlaHsd mice (n= 4) for 3 consecutive days. The control group was administered the vehicle only. Two days after the last application, the mice were injected with radiolabeled thymidine (methyl-3H-thymidine). The mice were killed approximately 5 hours after the injection, and the draining auricular lymph nodes were excised and pooled per group. The concentration of the radiolabel was measured.
EC3 is the estimated concentration of a chemical necessary to cause a 3 -fold increase in lymph node cell proliferative activity. Chemicals that at 1 or more test concentrations provoke a 3-fold or greater in lymphnode cell proliferation compared with vehicle controls are classified as potential contact allergens.
The Stimulations Indices[SI] were 1.2, 2.7, 3.6, 7.9 and 11.4 for the concentrations 1%,5%,10%,25%, 50% respectively.
The calculated EC3 value for the test chemical was 6.7% w/v and 12.96% for the positive control, α- hexylcinnamaldehyde.
Based on the above findings the test chemical can be considered to be sensitizing to skin.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Available studies for the test chemical indicate a very strong possibility that the test chemical has the potential to cause moderate sensitization to skin. Hence, the test chemical can be considered to be a skin sensitizer.
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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