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EC number: 283-298-7 | CAS number: 84604-20-6 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Silybum marianum, Compositae.
- 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
Water solubility
Administrative data
Link to relevant study record(s)
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 March 2019 to 22 March 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Version / remarks:
- Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Part A, A.6 Water Solubility
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Version / remarks:
- Organisation for Economic Co-operation and Development (OECD), OECD Guidelines for Testing of Chemicals, Guideline No. 105, "Water Solubility", adopted July 27, 1995
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Specific details on test material used for the study:
- No further details specified in the study report
- Key result
- Water solubility:
- < 0.1 vol%
- Conc. based on:
- test mat.
- Temp.:
- 20 °C
- Remarks on result:
- other: pH, loading & incubation not specified
- Details on results:
- It should be noted that the Test Item is an UVCB substance. Therefore, the calculated value is only a theoretical concentration. This theoretical calculation assumes, that the carbon content of the pure Test Item and the carbon content of the dissoluble fraction are not different from each other, furthermore that all component has similar solubility in water.
The water soluble fraction of the test item depends on the actual amount of the test item (approximatelly 0.0032% of the test item can be soluble in water) therefore there is no well determined water solubility and the finding of a saturation plateau was not possible. - Conclusions:
- The water soluble fraction of the test item depends on the actual amount of the test item (approximately 0.0032% of the test item can be soluble in water) therefore there is no well determined water solubility and the finding of a saturation plateau was not possible.
- Executive summary:
The purpose of this study is to determine the organic carbon content of the water soluble fraction of Extract of Chardon marie without support, which is specified by the saturation mass concentration of the test item in water preferably at 20±0.5°C.
Although, as the expected water solubility is close to 10-2g/L, the flask method will be applied due to technical reasons (relatively large volumes with repeat samples are required, only a flask mixture can provide this).
It should be noted that the Test Item is an UVCB substance. Therefore, the calculated value is only a theoretical concentration. This theoretical calculation assumes, that the carbon content of the pure Test Item and the carbon content of the dissoluble fraction are not different from each other, furthermore that all component has similar solubility in water.
The water soluble fraction of the test item depends on the actual amount of the test item (approximately 0.0032% of the test item can be soluble in water) therefore there is no well determined water solubility and the finding of a saturation plateau was not possible.
Reference
|
Measured carbon content % |
|
|
Nominal concentration (approx.) |
100 mg/L |
500 mg/L |
2500 mg/L |
Days |
|||
1 |
0.003203 |
0.002665 |
0.002598 |
2 |
0.001844 |
0.002519 |
0.002337 |
3 |
0.003556 |
0.002454 |
0.002527 |
Mean |
0.002867664 |
0.002546146 |
0.002487334 |
0.000903843 |
0.000108178 |
0.000135349 |
|
RSD% |
31.518440048 |
4.248704989 |
5.441543995 |
BQL |
|
Measured carbon content mg carbon/L |
||
Nominal concentration (approx.) |
100 mg/L |
500 mg/L |
2500 mg/L |
Days |
|||
1 |
0.320275 |
1.332717 |
6.495681 |
2 |
0.184413 |
1.259300 |
5.841322 |
3 |
0.355611 |
1.227202 |
6.318000 |
Mean |
0.286766394 |
1.273072912 |
6.218334584 |
0.090384294 |
0.054089112 |
0.338373412 |
|
RSD% |
31.518440048 |
4.248704989 |
5.441543995 |
BQL |
|
Calculated soluble test item content % |
||
Nominal concentration |
100 mg/L |
500 mg/L |
2500 mg/L |
Days |
|||
1 |
0.004118 |
0.003427 |
0.003341 |
2 |
0.002371 |
0.003239 |
0.003004 |
3 |
0.004573 |
0.003156 |
0.003250 |
Mean |
0.003687365 |
0.003273943 |
0.003198320 |
0.001162200 |
0.000139100 |
0.000174038 |
|
RSD% |
31.518440048 |
4.248704989 |
5.441543995 |
BQL |
|
Calculated soluble test item content mg/L |
||
Nominal concentration (approx.) |
100 mg/L |
500 mg/L |
2500 mg/L |
Days |
|||
1 |
0.411824 |
1.713665 |
8.352426 |
2 |
0.237126 |
1.619262 |
7.511022 |
3 |
0.457260 |
1.577989 |
8.123956 |
Mean |
0.368736523 |
1.636971727 |
7.995801188 |
0.116220000 |
0.069550099 |
0.435095039 |
|
RSD% |
31.518440048 |
4.248704989 |
5.441543995 |
BQL |
Description of key information
Water solublity <0.1%
Key value for chemical safety assessment
Additional information
As the expected water solubility is close to 10-2 g/L, the flask method will be applied due to technical reasons (relatively large volumes with repeat samples are required, only a flask mixture can provide this).
It should be noted that the
Test Item is an UVCB substance. Therefore, the calculated value is only
a theoretical concentration. This theoretical calculation assumes, that
the carbon content of the pure Test Item and the carbon content of the
dissoluble fraction are not different from each other, furthermore that
all component has similar solubility in water.
The water soluble fraction of the test item depends on the actual amount
of the test item (approximately 0.0032% of the test item can be soluble
in water) therefore there is no well determined water solubility and the
finding of a saturation plateau was not possible.
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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