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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
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22.04.2021 - 30.04.2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- - Name of test substance: Santalol oil
- Test substance No.: 20/0281-1
- Batch identification: 2007VD01SALraw0
- Cas-No.: 2576531-09-2
- Purity: 100% UVCB
- Content: (Z)-alpha-santalol: 29.5 - 30.2%; (Z)-beta-santalol: 19.7 - 19.1%
- Homogeneity: Given
- Storage stability. Expiry Date: 24.08.2021 - Analytical monitoring:
- yes
- Details on sampling:
- Samples for concentration control analysis were taken from each freshly prepared solution (0 and 24 h) without daphnids, and at the end of each exposure interval (24 and 48 h) from all test vessels with daphnids, and from the additional abiotic replicates without daphnids (pooled replicates).
All samples were collected with a glass pipette and placed into 50 mL glass samples vials. For each concentration, two retained samples were taken at each time point.
Exactly 9 mL of each samples solution was mixed with 200 µL 1,4-dioxane and 100 µL ISTD 1.1. The mixtures were extracted using a laboratory shaker with 1 mL hexane for 1 hour. The hexane extracts were used for analysis. - Vehicle:
- no
- Details on test solutions:
- TEST SUBSTANCE PREPARATION
The test substance is poorly soluble in water. Therefore, the test solutions were prepared following general guidance provided in OECD 23 to achieve a water accommodated fraction (WAF) of the test substance.
Each test solution was prepared separately (differential loading) by directly adding test substance to test medium.
Glass aspirator bottles (2-L) with a bottom side-outlet attached to a stopcock were filled with 2.2-L test media. For each test solution the test substance was pipetted carefully on the water surface, respectively. The bottles were closed and the solutions stirred on a magnetic plate for approx. 96 hours. The stirring was slow (approx. 100 rpm) so that no vortex was formed. The undissolved test substance should remain on the surface and the required volume of the saturated solution (approx. 900 mL) was removed from the bottom of the bottles and inspected visually for the presence of any undissolved test substance by observing the scattering of a laser light through the test solution (Tyndall effect).
Fresh test solutions were prepared daily and the test was performed in closed test vessels to maximize the exposure to all soluble components of the test substance. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Name: Daphnia magna STRAUS
- Age at study initiation (mean and range, SD): < 24 h
- Stage and instar at study initiation: First instar, at least 3rd brood progeny
- Method of breeding: Daphnia brood stock are kept in mass cultures consisting of approx. 20- 30 parthenogenetically reproducing females for a maximum of 4 weeks and fed live unicellular algae (Desmodesmus subspicatus), cultured continuously at the test facility. All individuals in each mass culture originate from a single female and are thus genetic clones. After approx. 14 days the adults have produced at least 3 broods and the young can be used in tests.
- Source: The clone of Daphnia magna STRAUS 1820 used was supplied by the Institut National de Recherche Chimique Appliquée, France, in 1978. From this date on this clone was cultured and bred continuously in the Ecotoxicology Laboratory of Experimental Toxicology and Ecology, BASF SE, Ludwigshafen, Germany.
- Feeding during test: No
ACCLIMATION
- Acclimation conditions (same as test or not): The Daphnia are cultured under the identical conditions as the test including test media (Elendt M4), water quality and temperature (20 +/- 1°C)
- Type and amount of food: unicellular green algae, Desmodesmus subspicatus
- Feeding frequency: Daily - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Hardness:
- 2.20 mmol/L
- Test temperature:
- 19.5 - 20.3°C
- pH:
- 8.0
- Dissolved oxygen:
- 8.2 - 8.6 mg/L
- Conductivity:
- 608 µS/cm
- Nominal and measured concentrations:
- Nominal test concentrations [mg/L]: 0 (control), 0.46, 1.0, 2.2, 4.6, 10.0 (as loading concentration, based on test substance density without a correction for purity or composition);
Mean measured test concentrations [µg/L]: 0 (control), 0.16, 0.46, 1.18, 3.37, 5.65 (based on test substance density without a correction for purity or composition) - Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass flasks (50 mL nominal volume)
- Type (delete if not applicable): closed (sealed with ground glass stoppers)
- Volume of solution: approx. 50 mL
- Aeration: none
- Renewal rate of test solution: Daily renewal of test solution
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per abiotic (no organisms) control (replicates): 2
- Biomass loading rate: approx. 0.1
- Feeding: No feeding during the exposure period
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light: 8 hours darkness
- Light intensity: 184 - 772 lux at a wavelength of 400 - 750 nm
EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
- Immobilization (mortality): daily
- Sublethal effects: daily
VEHICLE CONTROL PERFORMED: no - Reference substance (positive control):
- yes
- Remarks:
- Sodium chloride
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EL50
- Effect conc.:
- 0.55 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- Loading rate
- Basis for effect:
- other:
- Remarks:
- Immobilization
- Details on results:
- - Behavioural abnormalities: -
- Observations on body length and weight: -
- Other biological observations: -
- Other adverse effects control: -
- Immobilisation of control: No immobile Daphnia were observed in the control over the test duration
- Abnormal responses: -
- Dissolution behavior: All of the test solutions were visibly clear and colorless after preparation and remained so after 24 and 48 hours of exposure in the test. No undissolved test substance was visible in the respective solutions and there were no other remarkable observations - Results with reference substance (positive control):
- Reference substance tests are conducted monthly and according to OECD 202 guideline under GLP accordance (but without GLP status).
The EC50 (48h) of the reference substance sodium chloride was 5.17 g/L (experiment date: 21.04.2021, project number: 50E0789/12E067). This result is within the range of 3.88 - 7.22 g/L and indicates that the culture of Daphnia magna used in this study is responding normally to toxic stress. - Validity criteria fulfilled:
- yes
- Conclusions:
- The 48h EL50 of Santalol oil in an acute toxicity test with Daphnia magna STRAUSS was 0.55 mg/L, based on the loading rates of the test item.
- Executive summary:
In a 48-hour acute toxicity study, neonate Daphnia magna were exposed to Santalol oil at loading rates of 0 (control), 0.46, 1.0, 2.2, 4.6 and 10.0 mg/L under daily-renewal conditions in accordance with the OECD 202 guideline. The water, pH, temperature and dissolved oxygen were within acceptable guideline specifications. Immobilization (mortality) and sublethal effects were observed daily.
The 48-h EL50 values determined in this acute toxicity study were:
- 0.55 mg/L (based on the loading rates of the test item)The measured concentrations deviated markedly from the loading rate. The test organisms were exposed to all soluble components of the test substance at the given loading rates under testing conditions.
The test substance is a UVCB and as such every constituent contribues to a different degree to overall solubility, depending on its own individual solubility and its mass fraction in the test substance. Thus, for an evaluation of the results the effect concentrations should be expressed based on the nominal loading rates andw ere considered to be an accurate represenation of exposure levels throughout the experiment.
Reference
Number of mobile Daphnids | ||||||||||||||
Nominal concentration [mg/L] | Number of mobile Daphnia at each observation period | |||||||||||||
Replicate 1 [h] | Replicate 2 [h] | Replicate 3 [h] | Replicate 4 [h] | ∑ | ||||||||||
0 | 24 | 48 | 0 | 24 | 48 | 0 | 24 | 48 | 0 | 24 | 48 | 24 h | 48 h | |
0 (control) | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 20 | 20 |
0.46 | 5 | 5 | 4 | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 20 | 19 |
1.0 | 5 | 1 | 0 | 5 | 2 | 0 | 5 | 0 | 0 | 5 | 1 | 0 | 4 | 0 |
2.2 | 5 | 1 | 0 | 5 | 1 | 0 | 5 | 0 | 0 | 5 | 0 | 0 | 2 | 0 |
4.6 | 5 | 0 | 0 | 5 | 0 | 0 | 5 | 0 | 0 | 5 | 0 | 0 | 0 | 0 |
10.0 | 5 | 0 | 0 | 5 | 0 | 0 | 5 | 0 | 0 | 5 | 0 | 0 | 0 | 0 |
Number of test animals per replicate: 5 |
Description of key information
In a 48-hour acute toxicity study, neonate Daphnia magna were exposed to Santalol oil at loading rates of 0 (control), 0.46, 1.0, 2.2, 4.6 and 10.0 mg/L under daily-renewal conditions in accordance with the OECD 202 guideline. Immobilization (mortality) and sublethal effects were observed daily.
The 48-h EC50 values determined in this acute toxicity study were:
- 0.55 mg/L (based on the loading rates of the test item)
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Dose descriptor:
- EC50
- Effect concentration:
- 0.55 mg/L
Additional information
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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