Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 401-680-5 | CAS number: 125304-04-3 TINUVIN 171; TINUVIN 571
- 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
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10.08. - 01.12.2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study, GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Version / remarks:
- adopted on September 21, 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations:
For the determination of the test item concentrations, duplicate samples were taken from the freshly prepared test media of all test concentrations and the solvent control at the start of the test (Day 0), and thereafter at every second test medium renewal (Days 5, 10, 14, 19). To determine the maintenance of the test item concentrations during the test medium renewal periods, two stability controls were performed (Day 0 to Day 3 and Day 10 to Day 12), corresponding to the two different renewal periods of 72 and 48 hours. The following stability samples were taken in duplicate:
a) Samples with food, incubated during the renewal periods under the same conditions as the test itself (however without daphnids). Sampling from the test itself was not possible, since the test medium volumes were too small for the analytical requirements.
b) Samples without food and test animals, incubated during the renewal periods under the same conditions as the test itself.
- Sample storage conditions before analysis: All samples were deep-frozen (at about -20 °C) immediately after sampling.
The concentrations of the test item were analyzed in at least one of the duplicate test medium samples from the highest nominal concentration of 0.20 µg/L, determined in the experiment as the NOEC. From the solvent control samples only one of the duplicate samples was analyzed from the sampling dates at Day 0, 3, 10, 12, and 19. The test concentrations below the NOEC were not analyzed, because they were not relevant for the interpretation of the biological results. - Vehicle:
- yes
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION:
Prior to the start of the test and prior to each test medium renewal, the test media and the
controls were prepared as follows:
First, a concentrated solution of the test item in DMF with a nominal concentration of 2.0 mg/mL was prepared by dissolving nominal 40 mg (range: 38.7 - 40.4 mg) of the test item completely in 20 mL DMF. In a series of subsequent dilution steps this concentrated solution was diluted with DMF to prepare the application solutions used for the dosage of the test media with different test concentrations. Then, identical volumes of each of the application solutions were dosed into test water to prepare test media of the corresponding test concentrations. For the preparation of the solvent control, DMF without test item was dosed into test water. The concentration of DMF was the same (100 pL DMF per liter test water) in all test media and in the solvent control.
- Controls: test water without addition of test item or solvent was used.
- Chemical name of vehicle: N,N-Dimethylformamide (DMF)
- Concentration of vehicle in test medium: 100 µL DMF/ L test water - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia Magna
- Strain/clone: clone 5
- Source: in-house breed
- Age of parental stock: The daphnids used for the test originated from parental daphnids that were at least 14 days old but not older than four weeks and were not first brood progeny. At the start of the test, the test animals were less than 24 hours old.
- Feeding during test: yes
- Food type: with green algae of the species Scenedesmus subspicatus and with a fish food suspension.
- Amount: not specified
- Frequency: three times a week
ACCLIMATION
- Acclimation period: no - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 21 d
- Hardness:
- 2.5 mmol/L (= 250 µg/L as CaCO3)
- Test temperature:
- 19-20 °C during the test period
- pH:
- between 7.7 and 8.0 during the test.
- Dissolved oxygen:
- between 8.2 and 9.2 during the test.
- Nominal and measured concentrations:
- Nominal: 0.013, 0.025, 0.050, 0.10, and 0.20 µg/L
0.20 µg/L: Mean measured concentration: 0.09 µg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: 100 mL beaker
- Type: test vessels were covered with glass plates
- Material, size, headspace, fill volume: glass beaker containing 80 mL of test medium.
- Aeration: Before use, the test water was aerated until oxygen saturation. During the test, the test media were not aerated.
- Renewal rate of test solution (frequency/flow rate):
In this semi-static test, the test media of all test concentrations and of the control were renewed on Days 3, 5, 7, 10, 12, 14, 17, and 19 of the test period (every Monday, Wednesday, and Friday). In the end, a total of 8 test medium renewals were performed.
- No. of organisms per vessel: 1 (kept individually)
- No. of vessels per concentration (replicates): 10
- No. of vessels per vehicle control (replicates): 10
- No. of vessels per control (replicates): 10
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water
- Culture medium different from test medium: No
- Intervals of water quality measurement:
At the beginning and end of each test medium renewal period, the pH values and dissolved oxygen concentrations were measured in one of the beakers of each test concentration and of the control and of the solvent control. At the same time periods, the water temperature was measured in one of the control beakers. Additionally, the air-temperature in the testing room was continuously recorded by a temperature recorder. The appearance of the test media was visually recorded at each of the above mentioned intervals.
OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod: Photoperiod of 16 hours light and 8 hours darkness, with a 30 minute transition period (light intensity during light period within the range of about 470 and 640 Lux)
- Light intensity: 470 - 640 LUX
EFFECT PARAMETERS MEASURED:
The test replicates were observed for mortality of adults at the start of the test, on the first and third day after treatment and thereafter three times per week before renewal of test media. On the same observation dates, starting from Day 5, the number of offspring was recorded. Dead animals were removed at the renewal of the test media. The reproduction rate was calculated as the total number of living offspring produced per parent female surviving until the end of the test.
VEHICLE CONTROL PERFORMED: yes
RANGE-FINDING STUDY
- Results used to determine the conditions for the definitive study:
The test concentrations were based on the results of a range finding test and on preexperiments to the dosage of the test item in test water (without GLP). Concentrations far above the water solubility limit of the test item in test water (0.15 pg/L) were not tested. - Reference substance (positive control):
- no
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- > 0.2 µg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- immobilisation
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- > 0.09 µg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- immobilisation
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 0.2 µg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- immobilisation
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 0.09 µg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- immobilisation
- Details on results:
- - Mortality of parent animals: At the end of the test, the survival rate of the test animals was 90% in the control and 100% in the solvent control and at all test concentrations
- No. of offspring produced per day per female: The mean reproduction rate of the daphnids In the solvent control was 94.5 ± 8.0 living offspring per
adult (mean ± SD). The corresponding value in the control was 97.9 ± 4.4.
- Body length and weight of parent animals: no data
- Type and number of morphological abnormalities: not observed
- Type and number of behavioural abnormalities: not observed
- Number of males and females (parental): not specified - Reported statistics and error estimates:
- The NOEC and the LOEC of the reproduction rate were statistically evaluated by testing the mean reproduction rate at the test concentrations for statistically significant differences to the solvent control value by the multiple Williams-test after a one-way analysis of variance (ANOVA). The EC50 of the reproduction rate after 21 days could not be calculated due to the absence of a toxic effect of the test item on the reproduction rate up to the highest test concentration.
Reference
TEST ITEM CONCENTRATION
The measured test item concentration in the analyzed test medium of nominal 0.20 µg/L varied in the range of 22 to 87% of the nominal value at the start of the test medium renewal periods. At the end of the test medium renewal periods of two and three days, the measured concentration in the samples with and without food was in the range of 17 to 66% of nominal.. Using the measured concentrations, the mean measured concentration (calculated as the average over all measurements) was 0.09 µg/L (45% of nominal).
Description of key information
Based on long-term (chronic) toxicity study data, the product is very likely not harmful to aquatic organisms.
Key value for chemical safety assessment
Additional information
The effect of the test item on the survival and reproduction of Daphnia magna was investigated in a semi-static test over 21 days according to the OECD Guideline 211. The nominal test concentrations were 0.013, 0.025, 0.050, 0.10, and 0.20 µg/L and a control and a solvent control. The mean measured concentration (calculated as the average over all measurements) was 0.09 µg/L (45% of nominal) for the highest concentration. Taking into account the survival rates and the reproduction rates of the test animals, the 21-day NOEC was determined to be nominal 0.20 µg/L (mean measured 0.09 (µg/L).
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.