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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 285-080-7 | CAS number: 85029-55-6
- 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:
- 13th June 2016
- 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)
- Version / remarks:
- Adopted 13 April 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: BBD02611V1-1.STEP
- Expiration date of the lot/batch: 6/12/2017 - Analytical monitoring:
- no
- Vehicle:
- no
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Juvenile Daphnia magna (Straus), less than 24 hours old, were taken from healthy parental laboratory cultures, held and maintained at the test facility. The culture was originally obtained from Smithers Viscient, Shawbury, UK.
- Test type:
- semi-static
- Water media type:
- other: Elendt M4 Medium
- Limit test:
- no
- Total exposure duration:
- 48 h
- Test temperature:
- 19.5 - 20.1°C
- pH:
- 7.46 - 7.63 @ 48hours
- Dissolved oxygen:
- 96 - 97 % (9.06 - 9.23mg/l) @ 48 hours
- Nominal and measured concentrations:
- Nominal concentrations: 0.625, 1.25, 2.5, 5.0 and 10mg/l
- Details on test conditions:
- Range-finding Test
The range-finding test was conducted at nominal test substance concentrations of 0.10, 1.0, 10 mg/L and 100% saturated solution; the 100% saturated solution concentration was prepared using a (water accommodated fraction) WAF preparation, consisting of ca 24-hour stir, ca 1-hour settling period followed by syphoning of aqueous phase. The test was performed under semi-static test conditions with renewal of test media at 24 hours. A control group was also included. Duplicate test vessels were prepared for the control and each test concentration. Based on nominal concentrations, the results of the range-finding test indicated that the 48-hour EC50 value would be between 1.0 and 10 mg/L.
Definitive Test
Based on the results of the range-finding test, for which the key results only have been reported, the definitive test was conducted at nominal test concentrations of 0.625, 1.25, 2.5, 5.0 and 10 mg/L.
The test was conducted with a semi-static test system design. Media was prepared at 0 and 24 hours.
Glass beakers (100mL) were used as test vessel (filled to approximately 50 mL) with clear petri dish lids. Four replicate test vessels were prepared for the control and for each test concentration.
At the start of the test and at the 24-hour media renewal, the 10 mg/L top concentration was prepared by weighing ca 10 mg of test substance and adding to 1000 mL of Elendt M4 medium. The remaining test concentrations were prepared by serial dilution from the 10 mg/L test concentration. A control treatment was prepared by adding Elendt M4 medium only to the control vessels.
Five juvenile Daphnia magna, less than 24 hours old, were added to each test vessel, using a wide bore pipette to avoid damaging the animals during transfer. The Daphnia magna were not fed during the test.
After 24 and 48 hours, the Daphnia magna in each test vessel were observed for evidence of immobility.
The observations differentiated between mobile and immobile daphnids. An individual was considered immobile if, when the contents of the test vessel were briefly agitated, it did not swim during a 15-second period of observation. In addition, Daphnia magna submerged in the body of the test media and those that were held at the surface of the test media were also recorded. - Reference substance (positive control):
- no
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- ca. 3.58 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- ca. 2.5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- Based on nominal concentrations, the 48-hour EC50 value was determined to be 3.58 mg/L. The corresponding No Observed Effect Concentration (NOEC) was considered to be 2.5 mg/L.
- Validity criteria fulfilled:
- yes
- Conclusions:
- The 48-hour acute toxicity of TEPA C8-10 FA to the freshwater planktonic crustacean, Daphnia magna, was determined in accordance with the requirements of OECD Chemicals Testing Guideline No. 202 Daphnia sp. Acute Immobilisation Test (adopted April 13 2004).
Based on nominal concentrations, the 48-hour EC50 value was determined to be 3.58 mg/L. The corresponding No Observed Effect Concentration (NOEC) was considered to be 2.5 mg/L.
The validity criteria for control immobility (≤10%) and dissolved oxygen (≥3 mg/L) were both satisfied. The test is therefore considered valid. - Executive summary:
The objective of the study was to determine the 48-hour acute toxicity of TEPA C8-10 FA against the mobility of the freshwater planktonic crustacean, Daphnia magna.
The study was conducted in accordance with the requirements of OECD Chemicals Testing Guideline No. 202 Daphnia sp. Acute Immobilisation Test (adopted April 13 2004).
Based on the results of a range-finding test, for which the key results only have been reported, a definitive test was conducted at nominal test concentrations of 0.625, 1.25, 2.5, 5.0 and 100 mg/L. A control (test medium only) was also included. The test was conducted under semi-static test conditions with media renewal at 24 hours.
At the start of the test, five juvenile Daphnia magna were added to each test vessel. The Daphnids were not fed during the test and were observed at 24 and 48 hours.
For the 0.625, 1.25, 2.5, 5.0, and 10 mg/L test concentrations, analysis of the freshly prepared media at 0 hours showed TOC concentrations to be 1.31, 2.35, 4.49, 9.24 and 18.6 ppm TOC, respectively. Analysis of the freshly-prepared media at 24 hours showed TOC concentrations to be 0.78, 0.58, 1.29, 2.96 and 6.35 ppm TOC. At 24 hours, analysis of the old, pooled media showed TOC concentrations of 0.51, 0.84, 1.61, 6.27 and 13.7 ppm TOC. At 48, hours analysis of the old, pooled media showed TOC concentrations of 0.30, 0.65, 1.37, 3.13 and 6.38 ppm TOC, respectively.
After 48 hours exposure during the definitive phase, all Daphnids at Control, 0.625, 1.25 and 2.5 mg/L nominal exposure concentrations were observed as mobile. All Daphnids observed at 5.0 and 10 mg/L nominal exposure concentrations were observed as immobile.
The 1EC50 values, the corresponding 2NOEC and 3LOEC values are presented in the table below. Results are based on nominal exposure concentrations.
Nominal concentration (mg/L)
24-hour
48-hour
EC50
9.41 (8.66 – NC)
3.58 (2.5 – 5.0)*
NOEC
5
2.5
LOEC
10
5
(x-x) 95% Confidence Limits
NC Not calculable
* Due to 100% inhibition observed at 5 mg/L and 0% mortality observed at 2.5 mg/L these were considered the confidence limits at 48 hours as CETIS cannot calculate confidence limits without partial mortality
1 Concentration resulting in 50% immobility of exposed Daphnia magna
2 No observed effect concentration
3 Lowest observed effect concentration
The validity criteria for control immobility (≤10%) and dissolved oxygen (≥3 mg/L) were both satisfied. The test is therefore considered valid.
Study Number 3201561
Final Report
- 8 -
The validity criteria for control immobility (≤10%) and dissolved oxygen (≥3 mg/L) were both satisfied. The test is therefore considered valid.
Reference
Description of key information
The test substance (85029 -55 -6; Aradur 223) was tested in accordance with OECD Test Guideline 202 under GLP conditions and without deviations. The resulting EC50 after 48 hours of contact was determined to be 3.58mg/l based on nominal concentrations.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 3.58 mg/L
Additional information
Supporting studies are available and presented. These are based on structural analogues.
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.