Registration Dossier
Registration Dossier
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: 911-553-0 | CAS number: -
- 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 item is not considered a skin sensitizer under the test conditions of this study.
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:
- 20.12.2017 - 20.04.2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The solubility of the test item in test specific solvents was determined in pre-tests. The test item was insoluble in all solvents indicated by the respective OECD guidelines at the required concentrations. Even after sonication, precipitation was clearly visible with the unaided eye. Under these circumstances, in vitro skin sensitization testing according with OECD 442C, OECD 442D, and OECD 442C of the substance is not possible. Testing with precipitates is technically not feasible in case of DPRA and h-CLAT, and it is not recommended in case of the LuSens test, since a significant result cannot be obtained.
Other validated in vitro tests on skin sensitization are not available at present. - Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- Number and Sex of Animals: 29 females
Age at First Dose: 9-11 weeks, female animals, non-pregnant, and nulliparous were used
Animal Health: The health condition of animals was examined by a veterinarian before initiation of the study
Acclimation: The animals were acclimated in identical conditions as during the experiment for 5 days prior to the start of treatment. The acclimatio
n was according to standard operation procedures.
Housing Condition: The animals were housed in IVC polycarbonate cages (5 animals percage) suspended on stainless steel racks, in a room equipped
with central air-conditioning. Room temperature of 22 ± 3 °C, relative humidity of 50 - 60 %, 12-hour light / 12-hour dark cycle.
Diet; A laboratory food ssniff (ssniff Spezialdiäten GmbH, Germany) was served ad libitum, each day approximately at the same time.
Water: The animals received tap water for human consumption. Supply of drinking water was unlimited. The quality of drinking water is periodically
monitored (including microbiological control) and recorded;
Bedding: Lignocel S3/4, Lufa - ITL GmbH, Germany
Animals Identification : Each animal was marked with permanent pen on the tail.
Each cage was affixed with a cage card containing pertinent animal and study information.
Justification for theChoice of Species: The CBA/Ca mice are the standard experimental rodent of choice and recommended by OECD Guideline No. 429. - Vehicle:
- dimethyl sulphoxide
- Remarks:
- The vehicle (DMSO) was selected from the recommended vehicles according to OECD Guideline No. 429. The test item was not soluble in the vehicle; therefore, a homogeneous suspension was obtained.
- Concentration:
- 25 %, 50 % and 100 % w/v
The Pre-screen test was performed using a dose of 100 %. Based on the observations recorded in the
Pre-screen tests, the concentration of 100 % was selected as top dose for the main test. - No. of animals per dose:
- 5 (4 for pre-screen test)
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Parameter:
- SI
- Value:
- 2.24
- Test group / Remarks:
- 1000 mg/mL
- Parameter:
- SI
- Value:
- 1.87
- Test group / Remarks:
- 500 mg/mL
- Parameter:
- SI
- Value:
- 1.22
- Test group / Remarks:
- 250 mg/mL
- Key result
- Parameter:
- EC3
- Remarks on result:
- not determinable
- Remarks:
- The EC3 value could not be calculated, since none of the tested concentrations induced a S.I. greater than the threshold value of 3.
- Cellular proliferation data / Observations:
- The daily clinical observation of the animals did not show visible clinical signs.
The increase of body weight was observed at all used concentrations. The increase was statistically significant at concentration of 25 %.
In comparison with the control group, a minor increase of the pooled lymph node weights at all concentrations was observed. The increase was dose dependent.
The SI values for the three treated groups were 1.22 (25 %), 1.87 (50 %) and 2.24 (100 %), 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. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- These results demonstrate that the test item was not a skin sensitizer under the test conditions of this study.
- Executive summary:
The skin sensitization potential of the test item was evaluated by LLNA method, which basic underlying principle is that sensitizers induce a primary proliferation of lymphocytes in the auricular lymph nodes draining the site of chemical application.
In the present study, the test item was applied to the dorsum of each ear of five female mice (CBA/Ca) per group over three consecutive days, at three concentrations. All animals survived throughout the test period without showing any clinical signs. Calculated SI values in treated groups remained under the value of 3, which is the threshold to consider the substance as a sensitizer. Therefore, it was not possible to calculate an EC3 value.
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 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.
