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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 201-128-1 | CAS number: 78-63-7
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_ecotoxicological-information.png)
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:
- From 2008-10-07 to 2010-04-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well-conducted and documented study done according to established guidelines under GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 2008-11-12
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
PHYSICO-CHEMICAL PROPERTIES
- Melting point: no data
- Boiling point: no data
- Vapour pressure: no data
- Water solubility (under test conditions): 7 µg/L - Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 1.00, 1.10, 4.50, 4.95, 20.0, 21.6, and 22.0 µg/L
- Sampling method: Treatment samples and control samples were shaken manually to obtain homogeneous sample solutions. 100 mL of the treatment samples and control samples were extracted with 40 mL of ethyl acetate. Thus, the samples were concentrated by a factor of 0.4. The application solutions were diluted with ethyl acetate. Aliquots of the final solutions were analyzed by GC-MS.
- Sample storage conditions before analysis: no data - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Prior to the start of the test and prior to each test medium renewal, the test media and the controls were prepared as follows:
The application solution for the dosage of the highest test concentration was prepared by completely dissolving 20 mg (effective weights in the range of 20.0 to 20.2 mg) of the test item in 100 mL of DMF by intense mixing for 5 minutes. Further dilutions of this application solution with DMF were performed to obtain the application solutions for the dosage of the lower test concentrations. The application solutions were prepared once a week (three preparations during the test period) and were used for all test media preparations during this week. Between the test medium renewal periods, the application solutions were stored in a refrigerator. The stability of the application solutions during their use was examined in a pre-experiment (non-GLP). For the preparation of the test media, adequate volumes of the application solutions were added to the test water (100 μL per liter of test water) during intense stirring to obtain the test concentrations as stated above. The concentration of DMF was the same in all test media and in the solvent control (100 μL DMF per liter of test water).
- Eluate: ethyl acetate
- Differential loading: cf. Table 1 in "Any other information on material and methods incl. tables"
- Controls: For the control, test water without addition of test item or solvent was used.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): ethyl acetate. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnids
- Strain/clone: clone 5
- Source: supplied by the University of Sheffield/UK in 1992.
- Age of parental stock (mean and range, SD): at least 14 days old, and not older than 28 days old. They were not first brood progeny. At the start of the test, the test animal were less than 24 hours old.
- Feeding during test
- Food type: Green algae, Scenedesmus subspicatus; and with a fish suspension.
- Amount: no data
- Frequency: 3 times a week. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 21 d
- Post exposure observation period:
- no data
- Hardness:
- no data
- Test temperature:
- 20°C
- pH:
- 7.6-8.0
- Dissolved oxygen:
- 3 mg/L
- Salinity:
- not applicable
- Nominal and measured concentrations:
- - nominal concentrations: 0.93, 2.0, 4.3, 9.3, and 20 µg/L
- measured concentrations: 6.5 µg/L (time weighted mean of the highest test concentration) - Details on test conditions:
- TEST SYSTEM
- Test vessel: glass beaker
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: 80 mL of culture medium
- Aeration: no data
- Type of flow-through (e.g. peristaltic or proportional diluter):
- Renewal rate of test solution (frequency/flow rate): culture medium was changed twice a week.
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
- No. of vessels per vehicle control (replicates): not applicable
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted freshwater (Elendt M7 medium)
OTHER TEST CONDITIONS
- Adjustment of pH: no data
- Photoperiod: 16:8
- Light intensity: 500-630 lux
VEHICLE CONTROL PERFORMED: yes - Reference substance (positive control):
- no
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 20 µg/L
- Nominal / measured:
- nominal
- Duration:
- 21 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 20 µg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Details on results:
- no data
- Results with reference substance (positive control):
- not applicable
- Reported statistics and error estimates:
- no data
- Validity criteria fulfilled:
- yes
- Conclusions:
- The effect of the test item Peroxide, 1,1’-(1,1,4,4-tetramethyl-1,4-butanediyl)bis[2-(1,1 -dimethylethyl)] on the survival and reproduction of Daphnia magna was tested in a semi-static test over 21 days following the OECD Guidelines for Testing of Chemicals, 211. The test item had no toxic effects on survival and reproduction of Daphnia magna after the exposure period of 21 days up to the solubility limit of the test item in test water (approximately 7 μg/L) . Thus, the 21-day NOEC of the test item was determined to be at least 6.5 μg/L (nominal 20 μg/L). The 21-day LOEC was above the highest test concentration of 6.5 μg/L (nominal 20 μg/L). The 21-day EC50 for the inhibition of the reproduction rate of the daphnids was higher than 6.5 μg/L (nominal 20 μg/L).
- Executive summary:
The effect of the test item Peroxide, 1,1’-(1,1,4,4-tetramethyl-1,4-butanediyl)bis[2-(1,1 -dimethylethyl)] (CAS# 78-63-7) on the survival and reproduction of Daphnia magna was tested in a semi-static test over 21 days following the OECD Guidelines for Testing of Chemicals, No. 211 (1998): “Daphnia magna Reproduction Test”.
The nominal concentrations tested were 0.93, 2.0, 4.3, 9.3 and 20 μg/L. Additionally, a control and a solvent control were tested in parallel. The test method is based on the OECD Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures (2000). The measured test item concentrations in the samples from the freshly prepared test media of nominal 20 μg/L (NOEC) varied in the range of 44 to 121% of the nominal values. In the stability control samples without food particles and daphnids, the mean test item concentrations were in the range of 3-25% of the nominal values. In the stability control samples including food particles the mean test item concentrations had further decreased to 1-5% of the nominal values. The biological results were based on mean measured concentrations calculated as time-weighted means of the test item concentrations measured at the start of the test medium renewals and the concentrations measured in the stability control samples without food at the end of the renewal periods. The mean measured concentration of nominal 20 μg/l calculated as time-weighted mean was 6.5 μg/L.
The test item Peroxide, 1,1’-(1,1,4,4-tetramethyl-1,4-butanediyl)bis[2-(1,1-dimethylethyl)] (CAS# 78-63-7) had no toxic effects on survival and reproduction of Daphnia magna after the exposure period of 21 days up to the solubility limit of the test item in test water (approximately 7 μg/L) . Thus, the 21-day NOEC of the test item was determined to be at least 6.5 μg/L (nominal 20 μg/L). The 21-day LOEC was above the highest test concentration of 6.5 μg/L (nominal 20 μg/L). The 21-day EC50 for the inhibition of the reproduction rate of the daphnids was higher than 6.5 μg/L (nominal 20 μg/L).
Reference
Table 2: Results after 21 days of exposure of the test animals.
|
Control |
Solvent control |
Peroxide, 1,1'-(1,1,4,4-tetramethyl-1,4-butanediyl)bis[2-(1,1-dimethylethyl)] (nominal concentration µg/L) |
||||
|
|
|
0.93 |
2.0 |
4.3 |
9.3 |
20 |
Mortality (%) after 21 days of exposure |
0 |
0 |
10 |
0 |
0 |
0 |
0 |
Mean reproduction rate (living offspring per surviving adult) |
151.4 |
142.1 |
141.2 |
141.1 |
138.4 |
140.8 |
141.8 |
Mean reproduction rate in % of solvent control |
107 |
100 |
99 |
99 |
97 |
99 |
100 |
Description of key information
Höger, (2010), tested the effect of the test item Peroxide, 1,1’-(1,1,4,4-tetramethyl-1,4-butanediyl)bis[2-(1,1 -dimethylethyl)] (CAS# 78-63-7) on the survival and reproduction of Daphnia magna in a semi-static test over 21 days following the OECD Guidelines for Testing of Chemicals, No. 211 (1998): “Daphnia magna Reproduction Test”.The test item Peroxide, 1,1’-(1,1,4,4-tetramethyl-1,4-butanediyl)bis[2-(1,1-dimethylethyl)] (CAS# 78-63-7) had no toxic effects on survival and reproduction of Daphnia magna after the exposure period of 21 days up to the solubility limit of the test item in daphnid test medium (approximately 7 μg/L) . Thus, the 21-day NOEC of the test item was determined to be at least 6.5μg/L (nominal 20 μg/L). The 21-day LOEC was above the highest test concentration of 6.5 μg/L (nominal 20μg/L). The 21-day EC50 for the inhibition of the reproduction rate of the daphnids was higher than 6.5 μg/L (nominal 20μg/L). No toxicity was observed up to the maximum testable concentration in the study.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 6.5 µg/L
Additional information
Höger (2010), tested the effect of the test item Peroxide, 1,1’-(1,1,4,4-tetramethyl-1,4-butanediyl)bis[2-(1,1 -dimethylethyl)] (CAS# 78-63-7) on the survival and reproduction of Daphnia magna in a semi-static test over 21 days following the OECD Guidelines for Testing of Chemicals, No. 211 (1998): “Daphnia magna Reproduction Test”.
The nominal concentrations tested were 0.93, 2.0, 4.3, 9.3 and 20μg/L. Additionally, a control and a solvent control were tested in parallel. The test method is based on the OECD Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures (2000). The measured test item concentrations in the samples from the freshly prepared test media of nominal 20μg/L (NOEC) varied in the range of 44 to 121% of the nominal values (greater than the solubility of the test substance). In the stability control samples without food particles and daphnids, the mean test item concentrations were in the range of 3-25% of the nominal values. In the stability control samples including food particles the mean test item concentrations had further decreased to 1-5% of the nominal values. The biological results were based on mean measured concentrations calculated as time-weighted means of the test item concentrations measured at the start of the test medium renewals and the concentrations measured in the stability control samples without food at the end of the renewal periods. The mean measured concentration of nominal 20 μg/l calculated as time-weighted mean was 6.5μg/L, the maximum testable concentration of the test substance under the conditions of the study.
The test item Peroxide, 1,1’-(1,1,4,4-tetramethyl-1,4-butanediyl)bis[2-(1,1-dimethylethyl)] (CAS# 78-63-7) had no toxic effects on survival and reproduction of Daphnia magna after the exposure period of 21 days up to the solubility limit of the test item in test water (approximately 7 μg/L). Thus, the 21-day NOEC of the test item was determined to be at least 6.5μg/L (nominal 20 μg/L). The 21-day LOEC was above the highest test concentration of 6.5 μg/L (nominal 20μg/L). The 21-day EC50 for the inhibition of the reproduction rate of the daphnids was also higher than 6.5 μg/L (nominal 20μg/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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)