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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- methyl ethyl ketone
- Concentration:
- 5, 10, 25 %
- No. of animals per dose:
- 4
- Details on study design:
- A solubility experiment was performed according to the recommendations given by OECD 429. The highest test item concentration, which can be
technically used, was a 25 % (w/v) solution in methyl ethyl ketone while warming at 37°C and after vortexing. Grinding in a
mortar was necessary before formulating the test item. According to the information provided by the sponsor SAT 080003 is stable in methyl
ethyl ketone for up to 4h. In acetone:olive oil (4+1), a solution of 20% could be achieved while warming and sonicating.
In all other tested vehicles (dimethylformamide, propylene glycol, dimethylsulfoxide, ethanol:deionised water (7+3) and ethanol:deionised water
(3+7)) the test item could not be formulated.To determine the highest non-irritant test concentration, a pre-test was performed in two animals.
Two mice were treated with concentrations of 10 and 25% each on three consecutive days.
In the pre-test clinical signs were recorded within 1 hour and 24 ± 4 hours after each application as well as on day 7. At the tested concentrations
the animals did not show any signs of irritation or systemic toxicity.
The test item in the main study was assayed at 5, 10, and 25%. The top dose is the highest technically achievable concentration whilst avoiding
systemic toxicity and excessive local irritation. No severe irritant effects were tolerated choosing the test concentrations.
The test item was grinded in a mortar before formulation and placed into a volumetric flask on a tared balance and methyl ethyl ketone was
quantitatively added. The different test item concentrations were prepared by serial dilution.
The preparations were made freshly before each dosing occasion. Concentrations were in terms of material as supplied. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- EC3 = 12.9% (w/v)
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- other: Disintegration per minute (DPM)
- Value:
- 5 367
- Test group / Remarks:
- group 2: 5% test substance (vehicle: methyl ethyl ketone)
- Parameter:
- other: Disintegration per minute (DPM)
- Value:
- 4 267
- Test group / Remarks:
- group 3: 10% test substance (vehicle: methyl ethyl ketone)
- Parameter:
- other: Disintegration per minute (DPM)
- Value:
- 3 526
- Test group / Remarks:
- group 4: 25% test substance (vehicle: methyl ethyl ketone)
- Parameter:
- EC3
- Remarks on result:
- not determinable
- Remarks:
- none of the tested concentrations induced an S.I. greater than 3
- Key result
- Parameter:
- SI
- Value:
- 0.72
- Test group / Remarks:
- group 4: 25% test substance (vehicle: methyl ethyl ketone)
- Key result
- Parameter:
- SI
- Value:
- 0.88
- Test group / Remarks:
- group 3: 10% test substance (vehicle: methyl ethyl ketone)
- Key result
- Parameter:
- SI
- Value:
- 1.11
- Test group / Remarks:
- group 2: 5% test substance (vehicle: methyl ethyl ketone)
Any other information on results incl. tables
All treated animals survived the scheduled study period and no signs of toxicity were observed.
A test item is regarded as a sensitiser in the LLNA if the exposure to one or more test concentration resulted in 3-fold or greater increase in incorporation of 3HTdR compared with concurrent controls, as indicated by the Stimulation Index (S.I.). The estimated
concentration of test item required to produce a S.I. of 3 is referred to as the EC3 value.
In this study Stimulation Indices of 1.11, 0.88, and 0.72 were determined with the test item at concentrations of 5, 10, and 25% in methyl ethyl ketone. The EC3 value could not be calculated, since none of the tested concentrations induced an S.I. greater than 3.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test item SAT 080003 was not a skin sensitiser under the described conditions.
- Executive summary:
In the study the test item SAT 080003 dissolved in methyl ethyl ketone was assessed for its possible contact allergenic potential.
For this purpose a local lymph node assay was performed using test item concentrations of 5, 10, and 25% (highest achievable concentration).
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed.
In this study Stimulation Indices (S.I.) of 1.11, 0.88, and 0.72 were determined with the test item at concentrations of 5, 10, and 25% in methyl ethyl ketone, respectively.
The test item SAT 080003 was not a skin sensitiser in this 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.
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.
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