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EC number: 943-279-2 | 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
Skin sensitisation, In-Vivo (LLNA) - Not sensitising
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:
- 30 Aug - 19 Sep, 2017
- 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
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (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:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: H1L002
- Expiration date of the lot/batch: 31 Dec 2017
- Purity test date: 99.0% - Species:
- mouse
- Strain:
- CBA
- Remarks:
- CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: 9 – 13 weeks (Pre-tests 11-13 weeks; Main test 1-10 weeks)
- Weight at study initiation: Pre tests: 19.1 – 22.5g; Main test: 17.6 - 23.0 g
- Housing: Makrolon Type II (pre-test) / III (main study), with wire mesh top, granulated soft wood bedding.
- Diet: 2018C Teklad Global 18% protein rodent diet (certified), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 45-65%
- Photoperiod: artificial light: 6.00 a.m. - 6.00 p.m - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 2.5%, 5%, 10 %
- No. of animals per dose:
- 4
- Details on study design:
- MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay
- Criteria used to consider a positive response: A test item is regarded as a sensitiser in the LLNA if the exposure to one or more test concentration resulted in a 3-fold or greater increase in incorporation of 3HTdR compared with concurrent controls, as indicated by the Stimulation Index (S.I.).
In this study Stimulation Indices of 0.43, 0.73, and 1.09 were determined with the test item at concentrations of 2.5, 5, and 10% in acetone/olive oil (4+1 v/v). The EC3 value could not be calculated, since none of the tested concentrations induced a S.I. greater than the threshold value of 3. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Key result
- Parameter:
- EC3
- Remarks on result:
- not determinable
- Parameter:
- SI
- Value:
- 0.43
- Test group / Remarks:
- 2.5% (v/v)
- Parameter:
- SI
- Value:
- 0.73
- Test group / Remarks:
- 5% (v/v)
- Parameter:
- SI
- Value:
- 1.09
- Test group / Remarks:
- 10% (v/v)
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was not a skin sensitiser under the test conditions of the study.
The animals did not show any signs of systemic toxicity during the course of the study and no cases of mortality were observed.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
An in-vivo skin sensitisation study (local lymph node assay) was conducted (Envigo study WV64GB, 2017) to assess the potential of SIBE138 to cause skin sensitisation. SIBE138 was applied to skin at concentrations which were achieveable while not inducing systemic toxicity or excessive local skin irritation. Recorded stimulation indices were less than 3 at all concentrations tested; on this basis it was concluded that SIBE138 was not found to be a skin sensitiser under the test conditions employed.
On the basis that SIBE138 was found not to be sensitising in a relevant in-vivo test, the substance will not be classifed for skin sensitisation according to the CLP regulation (Regulation (EC) 1272/2008).
No relevant human or animal data are available to permit an independent assessment of the potential for respiratory sensitisation.
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