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EC number: 203-600-2 | CAS number: 108-62-3
- 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 study was performed to assess the skin sensitization potential of the test item using the murine local lymph node assay (LLNA). The study was performed in compliance with OECD Guideline No. 429. In order to find a suitable level for a main study, a preliminary study was conducted. One female was dosed at either 5, 10 or 25 w/v in acetone:olive oil (4:1 v/v). Results indicated that 25% w/v was a
suitable high dose level for the main study. In the main study, groups of four mice were dosed at three dosage levels and a vehicle control. Dosages were selected as follows: 5, 10 and 25% w/v in acetone:olive oil (4:1 v/v). In each phase of the study, the mice were treated by daily application of 25 ul of each of one of these three concentrations, or vehicle control, to the dorsal surface of both ears for three consecutive days.
In this assay the test/control ratios obtained for 5, 10 and 25% w/v were 0.4, 0.9 and 1.0 respectively, which indicates that LZ1060 Metaldehyde did not show the potential to induce skin sensitization
(delayed contact hypersensitivity). Responses to the positive control substance hexyl cinnamic aldehyde (HCA), in contemporaneous studies demonstrate the reliability and sensitivity of this assay to detect skin sensitization potential in this laboratory. The test item is not regarded as a potential skin sensitizer.
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:
- November 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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- - Identity: LZ1060 Metaldehyde
- Appearance: White powder
- Storage conditions: 4°C in the dark
- Expiry date: 20-October-2009 - Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd., Bicester, Oxon, England
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: good
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 18.8-21.9 g
- Housing: individually in polycarbonate cages with woodflake bedding
- Diet: Special Diet Services RMl (E) SQC
- Water (e.g. ad libitum): tap water
- Acclimation period: 5-6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2°C
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12h lightning / 12 h darkness - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- The maximum practical concentration for pinna dosing was 25% w/v in acetone:olive oil (4:1 v/v). Based on this information the following concentrations were selected for the preliminary study: 5, 10 and25% w/v
The results of the preliminary study indicated that 25% w/v was a suitable high dose level for the main study. Based on this information the following concentrations were selected for the main study: 5, 10 and 25% w/v - No. of animals per dose:
- Groups of four mice were treated at one of three concentrations (5, 10 and 25% w/v) of the test substance.
- Details on study design:
- The mice were treated by daily application of 25 ul of the appropriate concentration of the test substance to the dorsal surface of each ear for three consecutive days (Days 1-3). The test substance was applied to the dorsal surface of each ear using an automatic micropipette. The test substance was spread over the entire dorsal surface of the ear using the tip of the pipette. A further group of four mice received the vehicle alone in the same manner
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- None
- Positive control results:
- This positive control study was conducted between 16 and 30 November 2006 using sixteen mice of the CBA/Ca strain supplied by Harlan UK Ltd., Bicester, Oxon, England. Groups of four mice were used in this study. Three dosage levels and a vehicle control were used with dosages of HCA selected based on previous experience with HCA at this laboratory as follows: 10, 25 and 50% v/v in AOO ( 4: 1 v/v acetone:olive oil).
In this study the stimulation indexes (test/control ratio) obtained for 10, 25 or 50% v/v HCA were 7.9, 13.5 and 19.8 respectively. This indicates that HCA showed the potential to induce skin sensitization (delayed contact hypersensitivity) and confirms the sensitivity of the technique to detect skin sensitization. - Key result
- Parameter:
- SI
- Value:
- 0.4
- Variability:
- no data
- Test group / Remarks:
- 5% w/w test group conc.
- Key result
- Parameter:
- SI
- Value:
- 0.9
- Variability:
- no data
- Test group / Remarks:
- 10% w/w test group conc.
- Key result
- Parameter:
- SI
- Value:
- 1
- Variability:
- no data
- Test group / Remarks:
- 25% w/w test group conc.
- Cellular proliferation data / Observations:
- The test/control ratios obtained for 5, 10 and 25% w/v LZ1060 were 0.4, 0.9 and 1.0 respectively. As a test/control ratio of 3 or more was not recorded for any of the concentrations tested, LZ1060 is not considered to have the potential to cause skin sensitization (delayed contact hypersensitivity
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not regarded as a potential skin sensitizer.
- Executive summary:
The study was performed to assess the skin sensitization potential of the test item using the murine local lymph node assay (LLNA). The study was performed in compliance with OECD Guideline No. 429. In order to find a suitable level for a main study, a preliminary study was conducted. One female was dosed at either 5, 10 or 25 w/v in acetone:olive oil (4:1 v/v). Results indicated that 25% w/v was a
suitable high dose level for the main study. In the main study, groups of four mice were dosed at three dosage levels and a vehicle control. Dosages were selected as follows: 5, 10 and 25% w/v in acetone:olive oil (4:1 v/v). In each phase of the study, the mice were treated by daily application of 25 ul of each of one of these three concentrations, or vehicle control, to the dorsal surface of both ears for three consecutive days.
In this assay the test/control ratios obtained for 5, 10 and 25% w/v were 0.4, 0.9 and 1.0 respectively, which indicates that LZ1060 Metaldehyde did not show the potential to induce skin sensitization
(delayed contact hypersensitivity). Responses to the positive control substance hexyl cinnamic aldehyde (HCA), in contemporaneous studies demonstrate the reliability and sensitivity of this assay to detect skin sensitization potential in this laboratory. The test item is not regarded as a potential skin sensitizer.
Reference
Mortality and clinical signs:
There were no deaths and no signs of ill health or toxicity observed during this study. No signs of irritation were seen over the dosed area during the study. Greasy fur (cranial region) was noted for all control and test animals post-dose from Days 1 or 2. This sign had resolved completely in all animals by Day 6. Particles on ears were observed in all animals in the treated groups post dose from Day 1. This sign had resolved by Day 4.
Body weights:
A loss in body weight was recorded for one female in Group 2 and there was no bodyweight gain for one female in Group 4 during the study. All remaining animals gained weight during the study.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Guideline study; Klimisch 1
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available (further information necessary)
Justification for classification or non-classification
Based on the data available the substance is not classified or labeled according to Regulation 1272/2008/EC (CLP).
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