Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 685-540-0 | CAS number: 208126-52-7
- 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
Endpoint summary
Administrative data
Description of key information
one in vivo guideline study available on skin sensitisation
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26. October 1998 - 14. January 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test was conducted before Testguideline for LLNA (OECD Guideline 429, 2002) was adopted
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 8-8-A
- Expiration date of the lot/batch: 4. March 1999
- Purity test date: not stated
RADIOLABELLING INFORMATION (if applicable)
not applicable
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: not stated
- Solubility and stability of the test substance in the solvent/vehicle: not stated
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
none - Species:
- guinea pig
- Strain:
- other: Ibm: GOHI
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, Wölferstrasse 4, CH-4414 Füllinsdorf, Switzerland
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: SPF
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 408-426 g
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: one week
- Indication of any skin lesions: health examination performed before test,
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23 °C
- Humidity (%): 30-70
- Air changes (per hr): 10 -15 /h
- Photoperiod (hrs dark / hrs light): 12 / 12
- IN-LIFE DATES: 26. October - 3. December 1999 - Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- 5% test article in corn oil, 0.1 mL intradermal,
0.3 g test article, 75 % in corn oil, dermal application - Day(s)/duration:
- Day 1 (intradermal application), Day 8 (Epidermal application, 48 h) Day 22 (Challenge application, 24 h)
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- corn oil
- Concentration / amount:
- 75 %
- Day(s)/duration:
- 1
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS:
Intradermal Injection: According to Magnusson - Kligman and to the findings observed, the concentration selected for the main study was 5 %.
Epidermal application: According to Magnusson -Kligman and to the findings observed, the test article at 75 % was considered to be the maximally tolerated concentration to stimulate a state of immune hypersensitivity and the highest non-irritating concentration to be used for the challenge.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal, epidermal)
- Exposure period: 24 h for epidermal application
- Test groups: all
- Control group: all
- Site: dorsal skin from the scapular region (approx. 6 x 8 cm),
- Frequency of applications: intradermal 1, epidermal 1
- Duration: 24 h for epidermal application
- Concentrations: intradermal: 5 % in corn oil, epidermal: 75% in corn oil
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 h
- Test groups: all
- Control group: all
- Site: left or right flank, 5 x 5 cm
- Concentrations: 75 % in corn oil
- Evaluation (hr after challenge): 24 and 48 hours after removal of dressing - Challenge controls:
- none stated
- Positive control substance(s):
- yes
- Positive control results:
- Twenty percent of the test animals were observed with a very slight erythematous reaction at
the 24-hour reading after treatment with ALPHA-HEXYLCINNAMALDEHYDE at 1 % in
PEG 400. The same reactions still persisted at the 48-hour reading in two animals and were
also observed in a third animal. No reaction was observed in the control group I.
During the second challenge 90 % (at the 24-hour reading) and 80 % (at the 48-hour reading)
of the test animals were observed with very slight to well-defined (in one animal only)
erythema when treated with the test article at 5 % in PEG 400. The control group I, previously
exposed to the test article during the first challenge, also reacted up to 60 %. Although
erythematous reactions were observed in two animals used as pretest after epidermal
application of the test article at 5 %, no skin reaction was observed in the 5 animals of the
control group II (with FCNphysiological saline pretreatment), prepared in the same
conditions as the animals of the epidermal pretest and also treated as the control group I and
test group in the second challenge.
After treatment with the test article at 3 % in PEG 400, 40 % (at the 24-hour reading) and
30 % (at the 48~hour reading) of the test animals were observed with very slight erythematous
reactions while no skin reaction was observed in the control group I and II.
Therefore, the test article ALPHA-HEXYLCINNAMALDEHYDE applied at a concentration
of 1 %, 3 % and 5 % in PEG 400 is considered to be a sensitizer when used under the described test conditions. - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75 % in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75 % corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 5% Alpha-Hexylcinnamaldehyde
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 5 % Alpha-Hexylcinnamaldehyde
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- none
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study none of the animals of the test group were observed with erythematous reactions
after treatment with a non-irritant test article concentration of 75 % in corn oil. No skin
reactions were observed in the control group.
Therefore, the test article COSMOL 168AR applied at a concentration of 75 % in corn oil is
considered not to be a sensitizer when used under the described test conditions. - Executive summary:
In order to assess the cutaneous allergenic potential of COSMOL 168AR, the MaximizationTest
was performed in 15 (10 test and 5 control) female albino guinea pigs, in accordance
with OECD Guideline No. 406 and the Directive 96/54/EEC, B.6.
The intradermal induction of sensitization was performed with a 5 % dilution of the test
article in corn oil and in an emulsion of Freund's Complete Adjuvant (FCA) I physiological
saline. The epidermal induction of sensitization was conducted under occlusion with the test
article at 75 % in corn oil. Two weeks after the epidermal induction application the challenge
was completed by epidermal application of the test article at 75 % in corn oil under occlusive
dressing. The animals of the control group were induced with corn oil and FCA/physiological
saline and challenged similarly to those of the test group. Cutaneous reactions, i.e. erythema
and eschar, as well as oedema formation were evaluated at 24 and 48 hours after removal of
the dressing.
Erythematous Resations after the challenge procedure after 24 hours after 48 hours positive / total / % positive of total positive / total / % positive of total Control group Cosmol 168 AR (left flank) 0 / 5 / 0 0 / 5 / 0 Corn oil only (right flank) 0 / 5 / 0 0 / 5 / 0 Test Group Cosmol 168 AR (left flank) 0 / 5 / 0 0 / 5 / 0 Corn oil only (right flank) 0 / 5 / 0 0 / 5 / 0 No toxic symptoms were evident in the guinea pigs of the control or test group.
No deaths occured.
Reference
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
The available information on skin sensitisation is conclusive but not sufficient for classification.
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.