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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 472-690-5 | 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 results indicate that the test substance could elicit a SI >= 3. No reliable EC3 value could be calculated as the response of the 0.25% group did not follow the expected dose-response relationship. Since systemic toxicity was evident at higher dose levels, the response of the 0.25% concentration might be less due to underlying systemic toxicity. Based on these results, the substance would be regarded as 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:
- 2 - 30 October 2006
- 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)
- Version / remarks:
- April 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- April 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River France, L'Arbresle Cedex, France
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approx. 11 weeks
- Weight at study initiation: 20-26 g
- Housing: individual housing in labeled Macrolon cages containing sterilized sawdust as bedding material
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days before the start of treatment under lab conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.1-23.3 C
- Humidity (%): 42-89%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- methyl ethyl ketone
- Concentration:
- 0%, 0.05%, 0.1%, 0.25%
- No. of animals per dose:
- 5
- Details on study design:
- PRE-SCREEN TESTS:
- Doses: 0.25-0.5-1-2.5-5-10-25-50% test substance in methyl ethyl keton
- Systemic toxicity: noted at dose levels 25% (hunched posture) and 50% (sacrificed)
- Erythema scores: ranging between 2 and 3 on day 3 of all doses tested, oedema score was 0.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- Six monthly reliability check at 5%, 10% and 25%: EC3 value of 13.1%.
- Key result
- Parameter:
- SI
- Value:
- 3.5
- Test group / Remarks:
- 0.05%
- Key result
- Parameter:
- SI
- Value:
- 9.8
- Test group / Remarks:
- 0.1%
- Key result
- Parameter:
- SI
- Value:
- 6.7
- Test group / Remarks:
- 0.25%
- Cellular proliferation data / Observations:
- Erythema was observed in all animals while no oedema was noted. The irritation of the ears was considered not to have a toxicologically significant effect on the activity of the nodes. All nodes of the control and 0.05% treated groups were normal in size and the majority of the nodes of animals treated at 0.1% and 0.25% were increased in size. No macroscopic abnormalities of the surrounding area were noted. No adverse effects on body weight were noted.
No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study. - Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The results indicate that the test substance could elicit a SI >= 3. No reliable EC3 value could be calculated as the response of the 0.25% group did not follow the expected dose-response relationship. Since systemic toxicity was evident at higher dose levels, the response of the 0.25% concentration might be less due to underlying systemic toxicity. Based on these results, the substance would be regarded as a skin sensitiser.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The results indicate that the test substance could elicit a SI >= 3. No reliable EC3 value could be calculated as the response of the 0.25% group did not follow the expected dose-response relationship. Since systemic toxicity was evident at higher dose levels, the response of the 0.25% concentration might be less due to underlying systemic toxicity. Based on these results, the substance would be regarded as a skin sensitiser.
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.