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Diss Factsheets
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EC number: 433-060-5 | CAS number: 290822-07-0
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- study was conducted before the implementation of the LLNA
Test material
- Details on test material:
- - Expiration date of the lot/batch: None provided
- Receipt date: February 7, 2000
- Appearance: White to offwhite granules
- storage: stored at room temperature.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hilltop Lab Animals, Inc., Scottdale, Pennsylvania
- Age at study initiation: nn
- Weight at study initiation: nn
- Housing: Cage cards displaying at least the study number, animal number and sex were affixed to each cage. The animals were housed individually in suspended stainless steel cages. All housing and care were based on the standards recommended by the Guide for the Care and Use of Laboratory Animals
- Diet (e.g. ad libitum): PMI Certified Guinea Pig Chow ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-23
- Humidity (%): 32-60
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES: 2.3.-3.4.2000
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Injections for induction were as indicated below:
a. Injection Pair A: 0.1 mL of FCA emulsion
b. Injection Pair B: 0.1 mL of 1.0% test material in PEG 400
c. Injection Pair C: 0.1 mL of 1.0% test material/FCA emulsion
Challenge
- Route:
- intradermal and epicutaneous
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Injections for the challenge and rechallenge control animals were as indicated below:
a. Injection Pair A: 0.1 mL of FCA emulsion
b. Injection Pair B: 0.1 mL of PEG 400
c. Injection Pair C: 0.1 mL of 1.0% PEG 400/FCA emulsion
- No. of animals per dose:
- 10
- Details on study design:
- Dermal Observations
The test sites at challenge were graded for dermal irritation at approximately 24 and 48 hours following chamber removal using the Dermal Grading System
Clinical Observations
Any unusual observations and mortality were recorded. The animals were observed for general health/mortality twice daily, once in the morning and once in the afternoon.
Body Weights
Individual body weights were obtained for all sensitization study animals on the day prior to intradermal induction (day -1) and for the test and challenge control animals on the day prior to challenge dosing. Final body weights were collected for all animals prior to euthanasia.
Scheduled Euthanasia
All sensitization study animals were euthanized by carbon dioxide inhalation following each animal's final scoring interval. Gross necropsy examinations were not required for these animals. - Challenge controls:
- topical induction 0.8 ml PEG (solvent), challenge: 0.25g
- Positive control substance(s):
- yes
- Remarks:
- alpha-Hexylcinnamaldehyde
Results and discussion
- Positive control results:
- Using «-Hexylcinnamaldehyde as a positive control, Springbom Laboratories, Inc., Spencerville, Ohio, has completed a study during the past six months which provided historical control data for contact sensitization to this agent utilizing the test system described herein (Maximization Design). Following intradermal induction at 5.0% w/v alpha-Hexylcinnamaldehyde in propylene glycol, topical induction at 5.0% w/v alpha-Hexylcinnamaldehyde in propylene glycol and challenge at levels of 0.5% and 1.0% w/v «-Hexylcinnamaldehyde in propylene glycol, a contact sensitization response was observed, thereby demonstrating the susceptibility of the test system to this sensitizing agent.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study, the test substance is not considered to be a contact sensitizer in guinea pigs. The results of the alpha-Hexylcinnamaldehyde historical control study demonstrated that the test design utilized by Springbom Laboratories would detect potential contact sensitizers.
- Executive summary:
The dermal sensitization potential of the test substance was evaluated in Harley-derived albino guinea pigs. Ten male and ten female guinea pigs received intradermal injections of 1.0 % w/v of the test substance in polyethylene glycol 400 (PEG 400) along with injections of FCA and the test substance in FCA. One week later, the test animals received a topical application of 100 % test substance. Challenge and rechallenge control animals received similar intradermal and topical treatments except PEG 400 was used in place of the test article. Following a two-week rest period, a challenge was performed whereby the twenty test and ten challenge control guinea pigs were topically treated with 100 % w/v test substance. Challenge responses in the test animals were compared with those of the challenge control animals. Following the challenge with 100 % test substance, dermal scores of 0 to +/- were noted in all test animals, while dermal scores of 0 were noted in all challenge control animals. Group mean dermal scores in the test animals were comparable to the challenge control animals. Using alpha-Hexylcinnamaldehyde as a positive control, the laboratory has completed a study during the past six months which provided historical control data for contact sensitization to this agent utilizing the test system described herein (Maximization Design). Following intradermal induction at 5.0 % w/v alpha-Hexylcinnamaldehyde in propylene glycol, topical induction at 5.0 % w/v alpha-Hexylcinnamaldehyde in propylene glycol and challenge at levels of 0.5 % and 1.0 % w/v alpha-Hexylcinnamaldehyde in propylene glycol, a contact sensitization response was observed, thereby demonstrating the susceptibility of the test system to this sensitizing agent. Based on the results of this study, the test substance is not considered to be a contact sensitizer in guinea pigs. The results of the alpha-Hexylcinnamaldehyde historical control study demonstrated that the test design utilized by Springborn Laboratories would detect potential contact sensitizers.
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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