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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 233-759-3 | CAS number: 10347-88-3
- 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:
- 2017-05-23 to 2017-05-25
- 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:
- April 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Version / remarks:
- May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
- Version / remarks:
- 1996
- 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: Changzhou Sunlight Pharmaceutical Co., Ltd., China; 20160505 / 116727
- Expiration date of the lot/batch: May 2017
- Purity test date: 30.01.2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability under test conditions: stable - Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: For the analysis of the test item concentrations, samples of each test concentration (100 mg/L) and control were taken from the test solutions (4 x 5 mL at the start and 4 x 5 mL at the end of the study).
- Sampling method: Four parallel samples were taken from the 100 mg/L concentration level and from the control sample. The samples were prepared immediately after sampling. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test solution used in the test was prepared by mechanical dispersion. An appropriate amount of test item was dissolved in the dilution water (ISO medium) in order to obtain the concentration of 100 mg/L and this solution was placed into ultrasonic bath for 15 minutes. The resulted solution was the test concentration. Untreated control was included parallel in the test. The test solution was prepared immediately before introduction of daphnids.
- Controls: Yes. The dilution water (ISO-medium) was used without addition of the test item. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Water flea (Daphnia magna)
- Strain/clone: Daphnia magna (Straus)
- Source: Laboratory of Hydrobiology (Central Agricultural Office, Directorate of Plant-, and Soil Protection) 2100 Gödöllő, Kotlán S. u. 3. Hungary
- Sex: Female
- Age of parental stock: Less than 24 hours old
- Feeding during test: None
ACCLIMATION
- Acclimation: Test animals were bred under similar conditions as that used during the exposure period, therefore additional acclimatisation before the test was not necessary
- Food: The animals were fed with centrifuged green alga suspension
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Hardness:
- 249 mg/L (as CaCO3)
- Test temperature:
- 19.8 – 20.1 °C (measured in the test vessels)
19.2 – 20.1 °C (within the climate chamber) - pH:
- 6.00– 8.14
- Dissolved oxygen:
- 7.21 – 8.21 mg/L
- Nominal and measured concentrations:
- Nominal: 100 mg/L
Measured: The analytically determined concentration of the tested substance was maintained within ± 20 % of the nominal concentrations throughout the test. Therefore, the analysis of the results was based on the nominal concentration value. - Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass beakers of approximately 40 mL test medium
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ISO medium (according to OECD 202) was used as dilution water in the experiment.
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours light (artificial illumination) and 8 hours darkness
EFFECT PARAMETERS MEASURED:
The immobility or mortality of the Daphnia was determined by visual observation after 24 and 48 hours of exposure. Those animals not able to swim within 15 seconds after gentle agitation of the test beaker were considered to be immobile.
RANGE-FINDING STUDY
- Test concentrations: A non-GLP preliminary test was performed at the nominal concentation of 100 mg/L in order to check the toxicity of the test item on the daphnids up to at least this concentration.
- Results used to determine the conditions for the definitive study: In the preliminary test no immobility or any sub-lethal effect was detected in the treated concentration and in the control group during the 48-h exposure period. Based on the results of the preliminary test, a single test concentration at 100 mg/L nominal concentration and one control group were tested in a limit test. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Duration:
- 48 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- other: EC20
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- No immobilisation or any abnormal behaviour of test animals was observed in the control group and 10% immobilization was observed at the test concentration of 100 mg/L after 48 hours of exposure. No significant immobilisation was observed in the test concentration of the test item 3-Tert Butyladipic Acid during the 48-hour exposure of the test.
- Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- Relevant effect levels: The 24h EC50 is 1.41 mg/L (95% conf. limits: 1.19 – 1.68 mg/L) - Validity criteria fulfilled:
- yes
- Conclusions:
- In this 48-hour acute toxicity test on Daphnia magna, the obtained results showed that the test item had no significant toxic effects on the mobility of Daphnia up to the highest tested concentration of 100 mg/L. Thus, the 48h-EC50 was determined to be >100 mg/L and the NOEC was determined to be 100 mg/L. The results are based on the nominal test item concentration.
Reference
Table 1: Immobilisation of the test animals (summary table)
Nominal concentration [mg/L] |
No. of Daphnia tested |
No. of immobilized Daphnia after |
% of immobilized Daphnia after |
||
24 h |
48 h |
24 h |
48 h |
||
Control |
20 |
0 |
0 |
0 |
0 |
100 |
20 |
2 |
2 |
10 |
10 |
Validity of the Study
Control: The immobilisation rate of the introduced Daphnia did not
exceed 10 %. Immobility was not observed in the untreated control and
noDaphnia were trapped at the water surface or showed any sign of stress.
Dissolved Oxygen Concentration: The dissolved oxygen concentration at
the end of the test was more than 3 mg/L in control and test vessels.
All validity criteria were within acceptable limits and therefore the
study was considered as valid.
Analytical Results:
The measured concentration of the test item in the test solution was
102 % of the nominal value at the start and 102 % of the nominal value
at the end of the test. There is evidence that the concentration of the
tested substance was maintained within ± 20 % of the nominal
concentration throughout the test. Therefore the analysis of the results
was based on the nominal concentration values.
Table 2: Summarised measured concentration of the test substance in formulation samples
Sample date |
Nominal concentration (mg test item/L |
Mean of the measured concentrations (mg test item/L) |
Measured concentrations in percentage of the nominal |
Relative Standard Deviation % (n=4) |
23 May 2017 |
Control |
Not detected |
- |
- |
100 |
101.7 |
102 |
0 |
|
25 May 2017 |
Control |
Not determined |
- |
- |
100 |
101.8 |
102 |
1 |
Description of key information
In an acute toxicity study with Dahnia magan an EC50 of >100 mg/L and a NOEC of 100 mg/L were determined after 48 h of exposure to the test item.
Key value for chemical safety assessment
Additional information
An acute toxicity study accordingto OECD 202 was performed to evaluate the influence of the test item, 3 -Tert Butyladipic, on the mobility and survival of Daphnia magna. In a limit-test, conducted under static conditions, young Daphnia were exposed to aqueous test medium containing the test item at 100 mg/L nominal concentration for an exposure time of 48 hours. The obtained results showed that the test item had no significant toxic effect on the mobility of Daphnia at the limit concentration of 100 mg/L. Thus, the 48h-EC50 was determined to be >100 mg/L and the NOEC was determined to be 100 mg/L. The analytically determined concentration of the tested substance was maintained within ± 20 % of the nominal concentrations throughout the test. Therefore, the analysis of the results was based on the nominal concentration value.
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.