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Diss Factsheets
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EC number: - | 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 November 2012 - 28 March 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- LZ1554
- IUPAC Name:
- LZ1554
- Details on test material:
- - Name of test material (as cited in study report): LZ1554
- Physical state: Highly viscous brownish liquid
- Expiration date of the lot/batch: 15 July 2012
- Storage condition of test material: Room temperature in the dark, under nitrogen
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: a reputable supplier
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 15.5 to 21.6 g
- Acclimation period: 7 days
- Housing: animals were housed two animals per cage, in solid bottomed polycarbonate cages with a stainless steel mesh lid. Each cage contained a quantity of autoclaved wood flake bedding, additionally Nestlets and a plastic shelter were included for environmental enrichment.
- Diet (e.g. ad libitum): The animals were allowed free access to a standard rodent diet (Rat and Mouse No. 1 Maintenance Diet). This diet contained no added antibiotic or other chemotherapeutic or prophylactic agent.
- Water (e.g. ad libitum): Potable water taken from the public supply was freely available via polycarbonate bottles fitted with sipper tubes.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23°C
- Humidity (%): 40 to 70%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): Artificial lighting was controlled to give a cycle of 12 hours continuous light and 12 hours continuous dark per 24 hours.
IN-LIFE DATES
- From: 1st December 2011
- To: 3rd January 2012
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- preliminary test: 10, 25% and 50% w/v
main test: 5, 10 and 25% w/v - No. of animals per dose:
- 2 in preliminary test and 4 in main test
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: A vehicle trial performed with LZ1554 showed that it formed a brown solution at 50% w/v in acetone:olive oil (4:1 v/v), which was satisfactory for dose administration.
- Irritation: 50% w/v was the highest achieved concentration, but due to an increase in ear thickness recorded at this level, the next highest concentrations of 10 and 25% w/v were used in the main test.
- Lymph node proliferation response: not applicable
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: The animals were allocated without conscious bias to cages within the treatment groups.
- Criteria used to consider a positive response: Results for each treatment group were expressed as the Stimulation Index (SI), derived by dividing the mean dpm/mouse for each treated group and the positive control group by the mean dpm/mouse in the vehicle control group. If the SI is 3 or more, the test substance is regarded as a skin sensitizer.
TREATMENT PREPARATION AND ADMINISTRATION:
The test substance, LZ1554, was prepared for administration as a series of graded concentrations in the vehicle, by direct dilution.
The test substance was used as supplied and all formulations were prepared on the day of dosing at the required concentration(s).
The absorption of the test substance was not determined.
In the main phase of the study, five days following the first topical application of test substance (Day 6) all mice were injected via the tail vein with 250 µL of phosphate buffered saline containing 3H-methyl Thymidinea (3HTdR: 80 µCi/mL) giving a nominal 20 µ0Ci to each mouse. The injection into the tail vein was carried out using a plastic syringe and needle after the mouse had been heated in a warming chamber. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Not applicable
Results and discussion
- Positive control results:
- The SI for the positive control substance hexyl cinnamic aldehyde (HCA), was 10.2 which demonstrates the validity of this study.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 11.5
- Test group / Remarks:
- Concentration 5%
- Key result
- Parameter:
- SI
- Value:
- 19.5
- Test group / Remarks:
- Concentration 10%
- Key result
- Parameter:
- SI
- Value:
- 31.9
- Test group / Remarks:
- Concentration 25%
- Key result
- Parameter:
- EC3
- Value:
- 2.4
- Remarks on result:
- other: expressed in %
Any other information on results incl. tables
PRELIMINMARY TEST
There were no deaths and no signs of ill health were observed during this study.
No erythema was observed on the ears of any mouse on Days 1 to 6.
There was evidence of an effect of treatment on ear thickness for animals that received 50% w/v. Ear thickness on Day 6 was approximately 113 to 129% pre-dose values. There was no indication of an effect on ear thickness at 10 or 25% w/v.
There was no indication of an overt effect of treatment on bodyweight gain. On the basis of the results from the preliminary investigation, 25% w/v was considered a suitable high concentration for administration in the main phase of the study.
MAIN TEST
There were no deaths and no signs of ill health or toxicity were observed during this study.
No signs of dermal irritation were seen on the ears during the study. There was no indication of an effect of treatment on bodyweight gain.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LZ1554 is regarded as a potential skin sensitizer.
LZ1554 is classified as a skin sensitizer (category 1, sub category 1B) according to the Commission Regulation (EU) No. 286/2001 amending Regulation (EC) No. 1272/2008 on classification, labelling and packaging of substances and mixtures. - Executive summary:
The skin sensitization potential was determined in a GLP-compliant study in accordance with OECD no. 429 (Local Lymph Node Assay).
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.
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