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EC number: 273-381-6 | CAS number: 68958-92-9
- 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
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:
- 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
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: SPF
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 20.1 - 23.4 g
- Housing: in groups up to five animals
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 48 - 69
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: To: - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25, 50, 100%
- No. of animals per dose:
- 5
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: substance is liquid and missible with the vehicle
- Irritation: no
- Systemic toxicity: no
- Ear thickness measurements: yes
- Erythema scores: no
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA (OECD 429)
- Criteria used to consider a positive response: stimulation index (SI) was calculated based on DPM values; SI >= 3 indicates a sensitising potential
TREATMENT PREPARATION AND ADMINISTRATION:
the test substance was applied on three consecutive days on the dorsal surface of both ears (25 µl/ear) - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Key result
- Parameter:
- SI
- Value:
- 1.8
- Test group / Remarks:
- 25% concentration
- Key result
- Parameter:
- SI
- Value:
- 2.2
- Test group / Remarks:
- 50% concentration
- Key result
- Parameter:
- SI
- Value:
- 3
- Test group / Remarks:
- 100% concentration
- Remarks on result:
- other: see "Any other information on results"
- Interpretation of results:
- other: no skin sensitising potential
Reference
In this LLNA test at the highest dose of 100% test substance applied to the ears the calculated SI value reached the value of 3.0. However, the vehicle control group of this study showed a very low mean DPM value, amounting to 223 DPM. In a parallel LLNA test performed at the same time, with the same batch of animals and vehicle, in the vehicle control group the DPM value amounted to 532 (copies of the tables showing the DPM values of both studies are attached).
The DPM value of the vehicle control group was very low due to three animals having DPM values between 109 and 154. The two other animals of the control group had DPM values of 358 and 375. The DPM values of the five vehicle control animals of the parallel study had DPM values ranging from 375 to 706. These data show that (1) a brought range of DPM values in vehicle control animals is determined (from 109 to 706) and (2) that the random distribution of animals can lead to high variations of DPM values in control groups. The exchange of just one control animal between the two vehicle control groups would have resulted in a calculated SI value below 3.0. An increase of only 10 DPM of the mean DPM value of the vehicle control group, i.e. from 223 DPM to 233 DPM, results in an SI value < 2.9.
Taking these statistical and mathematical considerations together it is concluded that the SI value of 3.0 as calculated in this study is a borderline case not leading to classification of S-930 as having a skin sensitising potential.
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
No in vitro tests for testing of a skin sensitisation potential could be performed due to insolubility of the substance in test-compatible solvents. Therefore, an in vivo test (LLNA) was performed with the test substance. Based on the result it was concluded that the substance does not have a skin sensitising potential and therefore does not need to be classified according to Regulation 1272/2008.
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