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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 614-406-6 | CAS number: 68308-61-2
- 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
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
- The in vitro study was conducted according the OECD
guideline 429 and the EU-Guideline 42 (LLNA- Local Lymphe Node Assay) to
assess the skin sensitisation potential of GARDO TP. In the study (08/625
-03E) 16 female CBA/Ca mice (approximate age of 9 -10 weeks)were allocated
into four groups. Three groups received the appropriate formulation of
GARDO TP 10451 at concentration of 50 %, 25% or 10% in Acetone : Olive oil
4 : 1 mixture (AOO), the negative control group received the solvent
(AOO). Each animal was dosed once a day on three consecutive days (day 0,
1 and 2). There was no treatment on Days 3 and 4. No mortality occurred
but slight irritation with recovery was observed in all of the test item
treated groups. A lymphoproliferative response (SI >= 3) was noted for
GARDO TP 10451 at concentrations of 50% and 25%. The EC3 value of GARDO TP
10451 was 24.2% in this LLNA.
Thus, under the conditions of the LLNA assay, GARDO TP10451, dissolved in an appropriate solvent up to the maximum feasible concentration (50 %), was shown to have weak sensitisation potential (weak-sensitiser).
Although irritation was observed in the main assay it was not excessive. It is known that some non-sensitising irritant chemicals (such as sodium dodecyl sulphate) can give a slight positive response in the LLNA but there are also many irritants which do not give such a response. It is plausible that the slight increase in proliferation seen in this study could be secondary to the irritation effect, but there is no specific evidence to make this argument. So in line with the guidelines, the test item must be considered to be positive.
An in vivo study should be performed to verify this test result. For this reason, the performance of an in vivo study (Guinea-Pig Maximisation Test (GPMT)) is proposed and will be performed after approval by the authority.
Migrated from Short description of key information:
The test substance GARDO TP 10451 was examined in a skin sensitisation study in mice.
EC3: 24.2%
Justification for classification or non-classification
The EC3 value of GARDO TP 10451 derived from the skin sensitisation study (local lymph node assay) was 24.2% in CBA/Ca mice.
On the basis of published classification of contact allergens according to their potency, GARDO TP10451 can be ranked among weak sensitisers (100 >= EC3 (%) >= 10).
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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