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EC number: 234-091-5 | CAS number: 10528-67-3
- 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
The test substance was determined to be not skin sensitising.
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:
- 2003-08-28 to 2003-09-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2002
- Deviations:
- yes
- Remarks:
- non-radioactive, measurement of proliferation, comparable to OECD 442A
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 2003
- Deviations:
- yes
- Remarks:
- Please refer to Principles of method
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 442A (Skin Sensitization: Local Lymph Node Assay: DA)
- Version / remarks:
- 2010
- Principles of method if other than guideline:
- The deviations refer to the measurement of cell proliferation by cell counting instead of radioactive labeling. In addition, the acute inflammatory skin reaction was determined to discriminate specific from non-specific activation of immune competent cells in the draining lymph nodes. The principle was comparable to OECD Guideline 442A (2010-07-22).
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: 27 - 36 g
- Housing: Acclimation: MakrolonTM type III cages, up to 8 animals Study period: MakrolonTM type II cages, single animals
- Diet: ad libitum, PROVIMI KLIBA SA 3883 (Provimi Kliba SA, CH-4303 Kaiseraugst)
- Water: ad libitum, tap water
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 40 - 70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 3, 10 and 30 %
- No. of animals per dose:
- 6 per group
- Details on study design:
- - Compound solubility: was soluble in Aceton/Olive oil (4:1)
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: cell count index; ear swelling
- Criteria used to consider a positive response: cell count index: 1.35; ear swelling: 2x10-2 mm increase
TREATMENT PREPARATION AND ADMINISTRATION:
- formulation immediately before treatment in Aceton/Olive oil (4:1), visual: solution
- Application: epicutaneously onto the dorsal part of both ears, three consecutive days (d1, d2, d3)
- Volume: 25 µL/ear - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- when reasonable the Mann-Whitney or Wilcoxon significance test was performed
- Positive control results:
- Alpha hexyl cinnamic aldehyde was formulated in Aceton/Olive oil (4:1) at the concentrations of 3 %, 10 % and 30 %. The results showed that the positive control substance had a clear sensitizing potential.
- Parameter:
- other: Cell count index [%]
- Value:
- 1
- Variability:
- +/- 40.39
- Test group / Remarks:
- Control group
- Key result
- Parameter:
- other: Cell count index [%]
- Value:
- 0.88
- Variability:
- +/- 29.27
- Test group / Remarks:
- 3 % treatment group
- Key result
- Parameter:
- other: Cell count index [%]
- Value:
- 1.13
- Variability:
- +/- 11.94
- Test group / Remarks:
- 10 % treatment group
- Key result
- Parameter:
- other: Cell count index [%]
- Value:
- 1.06
- Variability:
- +/- 15.83
- Test group / Remarks:
- 30 % treatment group
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
The mice did not show an increase in the stimulation indices for cell counts or for weights of the draining lymph nodes after application of the test item.
CLINICAL OBSERVATIONS:
Both in ear swelling and ear weight the values of the treatment group were in the same range as the values of the control group.
BODY WEIGHTS
The body weights of the animals were not affected by any treatment. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- A modified Local Lymph Node Assay in mice was performed. Analysis of LLN weight and cell count index, ear swelling and weight showed no results that reached or exceeded the positive levels. Therefore the test substance was not sensitising.
- Executive summary:
The modified Local Lymph Node Assay (IMDS) was performed on 24 female NMRI mice of the strain Hsd Win:NMRI (6 animals/test item group and 6 control animals) to determine if there was any specific (sensitizing) or non-specific (irritating) stimulating potential of the test substance. The study was conducted according to OECD Guideline No. 429, EC Guideline 96/54/EC (22th Adaptation of Guideline 67/548/EEC)/Health Effects Test Guideline, OPPTS 870.2600 (EPA) with the concentrations of 0 %; 3 %; 10 % and 30 %. The test substance was formulated in Aceton/Olive Oil (A/OO, 4:1) to yield a solution. No increase in the stimulation indices for cell counts or for weights of the draining lymph nodes after application of the test substance was observed. The "positive level" which was 1.35 for the cell count index was never reached or exceeded in any dose group. The "positive level" of ear swelling which was 2x10^-2 mm increase, i.e. about 10% of the control values, had also not been exceeded in any dose group and no increases of the ear weights could be determined compared to control animals. The results showed that the test substance had neither an irritating nor a sensitizing potential in mice after dermal application.
Reference
Direct LLNA | ||
Dose [%] | Weight index (mean ± SD in %) | Cell count index (mean ± SD in %) |
Vehicle control | 1.00± 30.36 | 1.00 ± 40.39 |
3 | 0.87 ± 28.92 | 0.88 ± 29.27 |
10 | 1.04 ± 13.95 | 1.13 ± 11.94 |
30 | 0.97 ± 15.75 | 1.06 ± 15.83 |
The positive level was 1.35. No treatment group reached this level. All values were in the same range as the control group. Therefore the cell count index showed no increase in proliferating lymphocytes and the test substance is not sensitizing.
Ear swelling | |||
Dose [%] | day 1 (mean ± SD in %) | day 4 (mean ± SD in %) | Index day 4 |
Vehicle control | 18.25 ± 4.13 | 19.08 ± 7.23 | 1 |
3 | 18.00 ± 3.35 | 18.25 ± 6.66 | 0.96 |
10 | 18.83 ± 3.07 | 19.25 ± 7.39 | 1.01 |
30 | 17.83 ± 4.68 | 19.00 ± 5.50 | 1 |
Ear weight | ||
Dose [%] | day 4 (mean ± SD in %) | Index day 4 |
Vehicle control | 13.28 ± 5.78 | 1 |
3 | 12.77 ± 6.71 | 0.96 |
10 | 13.35 ± 8.06 | 1.01 |
30 | 12.39 ± 8.99 | 0.93 |
Both in ear swelling and ear weight the values of the treatment group were in the same range as the values of the control group. The index was never raised significantly. Therefore the ear swelling and ear weight showed no increase in proliferating lymphocytes and the test substance is not sensitizing.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitisation
A modified Local Lymph Node Assay in mice was performed comparable to OECD Guideline 442A. The measurement of cell proliferation was done by cell counting instead of radioactive labeling. In addition, the acute inflammatory skin reaction was determined to discriminate specific from non-specific activation of immune competent cells in the draining lymph nodes. The test substance was applied in concentrations of 3, 10 and 30 % to ears of 6 mice each. The LLN weight and cell count index, ear swelling and weight were analyzed. No increase in the stimulation indices for weights of the draining lymph nodes after application of the test substance was observed compared to the vehicle control. The maximal weight index was found with a 10 % test substance at 1.04 (± 13.95 %) (control: 1.00 (± 30.36 %)). The "positive level" which was 1.35 for the cell count index was never reached or exceeded in any dose group. The maximal index was found for cell count index with a concentration of 10 % at 1.13 (± 11.94 %) (control: 1.00 (± 40.39%)). The "positive level" of ear swelling which was 2x10^-2 mm increase, i.e. about 10% of the control values, had also not been exceeded in any dose group and no increases of the ear weights could be determined compared to control animals. The maximal values were found with a 10 % concentration of the test substance at an Index of 1.01 while the control index was 1.00. In conclusion in can be said that the results of the different analysis did not reach or exceed the positive levels. Therefore the test substance was concluded to be not skin sensitising.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on skin sensitisation, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the nineth time in Regulation (EU) No 2016/1179.
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