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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 814-233-8 | CAS number: 444649-70-1
- 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
Based on the results of LLNA, the test substance is not considered to be a skin sensitiser.
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:
- From June 17, 2015 to July 21, 2015
- 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:
- yes
- Remarks:
- but did not affect the validity of the study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- but did not affect the validity of the study
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Justification for non-LLNA method:
- -
- Specific details on test material used for the study:
- Batch no.: JBGJ0045R
Purity: 100% (UVCB)
Appearance: clear yellowish liquid - Species:
- mouse
- Strain:
- CBA/Ca
- Remarks:
- CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- Source: Harlan Laboratories B.V. Postbus 6174 5960 AD Horst / The Netherlands
Acclimatization: at least 5 days
Body weight: ca. 20g
Temperature: ca. 22±2°C, relative humidity : ca. 45-65% and light regimen: 12-hour light /12-hour dark cycle
Diet: 2018C Teklad Global 18% protein rodent diet, ad libitum
Water: tap water, ad libitum - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0, 0.5, 1 and 2.5% (w/w)
(Pre-tests: 50, 25, 10 and 5%) - No. of animals per dose:
- 4
- Details on study design:
- Three groups each of four female mice were treated with different concentrations (25 µL of 0, 0.5, 1, and 2.5% (w/w) in acetone/olive oil (4+1, v/v)) of the test substance by topical application at the dorsum of each ear once daily each on three consecutive days. The highest concentration tested was the highest concentration that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation as confirmed by three pre-experiments. A control group of four mice was treated with the vehicle only. Five days after the first topical application, the mice were intravenously injected into a tail vein with radio-labelled thymidine (3H-methyl thymidine; 3HTdR). Approximately five hours after intravenous injection, the mice were sacrificed and the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes, which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was then determined by the incorporation of 3H-methyl thymidine measured in a β-scintillation counter.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Mean values and standard deviations
- Positive control results:
- alpha- hexylcinnamaldehyde 25% (w/w) in acetone/olive oil (4+1, v/v): S.I. value of 9.5 and was therefore regarded as a sensitiser in the LLNA test, since the exposure to one or more test concentrations resulted in a 3-fold or greater increase in incorporation of 3HTdR compared with concurrent controls.
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 0.0% (w/w) in acetone/olive oil (4+1, v/v)
- Remarks on result:
- other: negative control
- Key result
- Parameter:
- SI
- Value:
- 0.84
- Test group / Remarks:
- 0.5% (w/w) in acetone/olive oil (4+1, v/v)
- Remarks on result:
- other: at 0.5% conc; not a skin sensitiser
- Key result
- Parameter:
- SI
- Value:
- 0.92
- Test group / Remarks:
- 1.0% (w/w) in acetone/olive oil (4+1, v/v)
- Remarks on result:
- other: at 1% conc; not a skin sensitiser
- Key result
- Parameter:
- SI
- Value:
- 1.22
- Test group / Remarks:
- 2.5% (w/w) in acetone/olive oil (4+1, v/v)
- Remarks on result:
- other: at 2.5% conc; not a skin sensitiser
- Cellular proliferation data / Observations:
- The animals did not show any signs of systemic toxicity during the course of the study and no cases of mortality were observed. The body weight of the animals, recorded prior to the first application and prior to treatment with 3HTdR, was within the range commonly recorded for animals of this strain and age. A very slight erythema (score: 1) was observed in the animals of the high dose group on test day 3. In this study, Stimulation Indices (S.I.) of 0.84, 0.92, and 1.22 were determined with the test substance at concentrations of 0.5, 1, and 2.5% (w/w) in acetone/olive oil (4+1, v/v), respectively. The test substance was not a skin sensitiser under the test conditions of this study.
(The estimated concentration of test substance required to produce a S.I. of 3 is referred to as the EC3 value. In this study, the EC3 value could not be calculated, since none of the tested concentrations induced a S.I. greater than the threshold value of 3.) - Interpretation of results:
- other: CLP criteria not met
- Remarks:
- does not need to be classified
- Conclusions:
- Under the study conditions, the test substance was not a skin sensitiser (LLNA).
- Executive summary:
A study was conducted to determine the skin sensitisation potential of the test substance according to OECD Guideline 429 and EU Method B.42, in compliance with GLP. Groups of 4 female CBA/Ca mice each were treated with 0, 0.5, 1, and 2.5% (w/w) preparations of the test substance in acetone/olive oil (4+1, v/v)) or with the vehicle alone. The highest concentration tested was the highest concentration that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation as confirmed by three pre-experiments. The study used 3 test groups and 1 control groups (vehicle). 25 µL of the respective test substance preparation or of the vehicle were applied to the dorsum of both ears of each animal once daily for three consecutive days. Five days after the first topical application, the mice were intravenously injected into a tail vein with radio-labelled thymidine (3H-methyl thymidine; 3HTdR). Approximately five hours after intravenous injection, the mice were sacrificed and the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes, which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was then determined by the incorporation of 3H-methyl thymidine measured in a β-scintillation counter. Mortality / viability was reported at least once daily from experimental start to necropsy. Body weights was measured prior to the first application and prior to treatment with 3HTdR. Clinical signs (local / systemic) were recorded at least once daily. The animals did not show any signs of systemic toxicity during the course of the study and no cases of mortality were observed. The body weight of the animals, recorded prior to the first application and prior to treatment with 3HTdR, was within the range commonly recorded for animals of this strain and age. A very slight erythema (score: 1) was observed in the animals of the high dose group on test day 3. In this study, Stimulation Indices (S.I.) of 1.00, 0.84, 0.92, and 1.22 were determined with the test substance at concentrations of 0, 0.5, 1, and 2.5% (w/w) in acetone/olive oil (4+1, v/v), respectively. The EC3 value could not be calculated, since none of the tested concentrations induced a S.I. greater than the threshold value of 3. Under the study conditions, the test substance was not a skin sensitiser (LLNA) (Roth, 2015).
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Reason / purpose for cross-reference:
- data waiving: supporting information
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A study was conducted to determine the skin sensitisation potential of the test substance according to OECD Guideline 429 and EU Method B.42, in compliance with GLP. Groups of 4 female CBA/Ca mice each were treated with 0, 0.5, 1, and 2.5% (w/w) preparations of the test substance in acetone/olive oil (4+1, v/v)) or with the vehicle alone. The highest concentration tested was the highest concentration that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation as confirmed by three pre-experiments. The study used 3 test groups and 1 control groups (vehicle). 25 µL of the respective test substance preparation or of the vehicle were applied to the dorsum of both ears of each animal once daily for three consecutive days. Five days after the first topical application, the mice were intravenously injected into a tail vein with radio-labelled thymidine (3H-methyl thymidine; 3HTdR). Approximately five hours after intravenous injection, the mice were sacrificed and the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes, which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was then determined by the incorporation of 3H-methyl thymidine measured in a β-scintillation counter. Mortality / viability was reported at least once daily from experimental start to necropsy. Body weights was measured prior to the first application and prior to treatment with 3HTdR. Clinical signs (local / systemic) were recorded at least once daily. The animals did not show any signs of systemic toxicity during the course of the study and no cases of mortality were observed. The body weight of the animals, recorded prior to the first application and prior to treatment with 3HTdR, was within the range commonly recorded for animals of this strain and age. A very slight erythema (score: 1) was observed in the animals of the high dose group on test day 3. In this study, Stimulation Indices (S.I.) of 1.00, 0.84, 0.92, and 1.22 were determined with the test substance at concentrations of 0, 0.5, 1, and 2.5% (w/w) in acetone/olive oil (4+1, v/v), respectively. The EC3 value could not be calculated, since none of the tested concentrations induced a S.I. greater than the threshold value of 3. Under the study conditions, the test substance was not a skin sensitiser (LLNA) (Roth, 2015).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the results of the LLNA, the test substancedoes not meet the criteria for classification for this endpoint according to CLP (Regulation 1272/2008/EC).
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.