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EC number: 473-310-0 | CAS number: 478385-88-5
- 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
LLNA study, OECD 429: not sensitising (reference 7.4.1 -1)
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:
- 2006-08-12 to 2006-09-12
- 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:
- 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)
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan NetherlandsB.V. Postbus 6174NL
- 5960 AD Horst / The Netherlands
- Age at study initiation: 8 - 12 weeks (beginning of treatment)
- Weight at study initiation: 22 +/- 1.5 g
- Housing: single
- Diet: ad libitum; pelleted standard diet
- Water: ad libitum
- Acclimation period: At least 5 days prior to the start of dosing under test conditions after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature: °C 22 +/- 3
- Humidity: 30-82 %
- Air changes: not specified
Photoperiod: 6 a.m. - 6 p.m. - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 5, 10, 25 wt. %
- No. of animals per dose:
- Total 16 animals:
3 test groups with 4 animals
1 control group with 4 animals - Details on study design:
- according to guideline
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations were calculated in the body weight tables. The ANOVA (Dunnett-test) was conducted to assess whether the difference is statistically significant between test item groups and negative control (vehicle) group. Statistical significance was at the five per cent level (p < 0.05). However, both biological and statistical significance were considered together.
- Positive control results:
- Based on the results obtained with the positive control, the study can be considered to be valid.
- Key result
- Parameter:
- SI
- Value:
- 1.38
- Test group / Remarks:
- Test Group (5%)
- Key result
- Parameter:
- SI
- Value:
- 1.62
- Test group / Remarks:
- Test Grouip (10%)
- Key result
- Parameter:
- SI
- Value:
- 1.23
- Test group / Remarks:
- Test Group (25 %)
- Cellular proliferation data / Observations:
- EC3 CALCULATION
All SI values are below 3, thus there was no calculation of the EC3 value.
CLINICAL OBSERVATIONS:
No clinical signs have been observed. No mortality was reported.
BODY WEIGHTS
Body weight development was without any abnormalities. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was found to be not a skin sensitiser under the described conditions.
- Executive summary:
The purpose of this Local Lymph Node assay was to identify the contact allergenic potential of the test material when administered to the dorsum of both ear lobes of mice. This study should provide a rational basis for risk assessment to the sensitising potential of the test item in man. In order to study a possible allergenic potential of the test material, three groups each of four female mice were treated with different concentrations of the test item dissolved in acetone/olive oil (4:1) by topical application at the dorsum of each ear lobe (left and right) on three consecutive days. 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). 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 determined by the incorporation of 3H-methyl thymidine measured in a beta-scintillation counter.
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed.
In this study Stimulation Indices (SI) of 1.38, 1.62 and 1.23 were determined with the test item at concentrations of 5, 10 and 25% (w/v) in acetone/olive oil (4/1), respectively.
In conclusion, the test material was not a skin sensitiser in this assay.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
LLNA study (reference 7.4.1 -2)
The purpose of this Local Lymph Node assay was to identify the contact allergenic potential of the test material when administered to the dorsum of both ear lobes of mice. This study should provide a rational basis for risk assessment to the sensitising potential of the test item in man. In order to study a possible allergenic potential of the test material, three groups each of four female mice were treated with different concentrations of the test item dissolved in acetone/olive oil (4:1) by topical application at the dorsum of each ear lobe (left and right) on three consecutive days. 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). 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 determined by the incorporation of 3H-methyl thymidine measured in a beta-scintillation counter. The animals did not show any clinical signs during the course of the study and no cases of mortality were observed.
In this study Stimulation Indices (SI) of 1.38, 1.62 and 1.23 were determined with the test item at concentrations of 5, 10 and 25% (w/v) in acetone/olive oil (4/1), respectively.
In conclusion, the test material was not a skin sensitiser in this assay.
Justification for classification or non-classification
Classification,
Labelling, and Packaging Regulation (EC) No 1272/2008
The
available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. Based on
available data the test item does not require classification as skin
sensitiser according to Regulation (EC) No 1272/2008 (CLP), as amended
for the twelfth time in Regulation (EU) 2019/521.
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