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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: - | 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-01-19 to 2010-04-16
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- 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)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): CAE
- Substance type: UVCB
- Physical state: oily semi-liquid orange-couloured to brown
- Purity test date: 12/01/2010
- Lot/batch No.: 1541
- Expiration date of the lot/batch: 27 November 2010
- Storage condition of test material: In an airtight container, under nitrogen, protected from the light and from the heat
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Breeder Janvier
- Age at study initiation: 9 weeks
- Weight at study initiation: 20.4 ± 1.1 g
- Housing: individual, crystal polystyrene cages
- Diet (e.g. ad libitum): "SSNIFF R/M-H pelleted maintenance diet", ad lib
- Water (e.g. ad libitum): drinking water filtered using a 0.22 micron meter filter, ad lib
- Acclimation period: 5 days at least
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 4 March 2009 To: 02 April 2009
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25, 10, 5, 2.5, 1 and 0 % (v/v)
- No. of animals per dose:
- 4 (at all doses)
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: appropriate solution in AOO vehicle
- Irritation: a range-finding test performed on mice at the concentrations of 10, 25, 50 and 100%
MAIN STUDIES
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: SI ≥ 3
TREATMENT PREPARATION AND ADMINISTRATION:
in the vehicle, at 25 µL on both ears - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The positive control results were valid: the conditions of the test allow the identification of positive dermal sensitisers.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Table 1
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Table 1
Any other information on results incl. tables
Table 1:
Concentration (% v/v in vehicle) |
dpm per node | SI | Increase in ear thickness (% between day 1 and day 6) | Interpretation of irritancy |
Vehicle AOO | 45.83 | - | 3.13 | - |
Test item 1% | 45.06 | 0.98 | 4.04 | Non irritant |
Test item 2.5% | 42.75 | 0.93 | 6.38 | Non irritant |
Test item 5% | 36.00 | 0.79 | 4.12 | Non irritant |
Test item 10% | 74.26 | 1.62 | 9.38 | Non irritant |
Test item 25% | 475.96 | 10.39 | 20.41 | Slightly irritant |
HCA 25% | 317.92 | - | - | - |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information See in Attached background material "Statement CAE JFN 24th July 2011.pdf" Criteria used for interpretation of results: expert judgment
- Conclusions:
- Preliminary experiments showed that CAE concentrations > 25% induced a skin irritation at day 6. Thus, the 25% concentration was retained for highest tested concentration for the LLNA. Conclusion was that CAE should be considered as a weak sensitizer since the EC3 value was equal to 12%.
Of note, the 25% CAE concentration was not totally devoid of irritant properties as reported by study director:
i) clinical observation showed dryness of the 25% C CAE-treated ears in all animals (4/4) and erythema in ¼ animals (page 7 and 20/33);
ii) a 20 to 30% ear thickness increase was noted at day 6 in all 25% CAE-treated animals (page 17/33-preliminary exp. and page 22/33 pivotal exp.). Therefore, we interpret the results of the LLNA as false positives because of the use of a “border-line” irritant concentration of CAE.
If the LLNA had been conducted with the non-irritant 10% concentration, it would have been negative. - Executive summary:
According to the study director, the test item should be considered as a weak sensitizer based on the EC3 of 12%.
According to the expert judgment, there are 4 types of arguments for not taking into account the positive CAE LLNA:
i) LLNA is not validated for UVCB;
ii) positive LLNA is not synonymous of skin sensitization properties;
iii) there are strong arguments to consider the positive LLNA as false-positive through an irritant effect of CAE and the vehicle;
iv) there is no bibliographic and epidemiological data on CAE-induced allergy.
Please see the document "Statement CAE JFN 24th July 2011.pdf" for more details.
Based on these arguments, CAE is non-classified as skin sensitiser.
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