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EC number: 218-259-5 | CAS number: 2095-06-9
- 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
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 September 2011 - 29 December 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.20 (Daphnia magna Reproduction Test)
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ISO International Standard 10706: “Determination of long term toxicity of substances to Daphnia magna Straus (Cladocera, Crustacea)”, 2000-03-30.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance document on aquatic toxicity testing of difficult substances and mixtures, OECD series on testing and assessment number 23, December 14, 2000.
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- p-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline
- EC Number:
- 225-716-2
- EC Name:
- p-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline
- Cas Number:
- 5026-74-4
- Molecular formula:
- C15H19NO4
- IUPAC Name:
- 4-(oxiran-2-ylmethoxy)-N,N-bis(oxiran-2-ylmethyl)aniline
- Test material form:
- liquid: viscous
- Details on test material:
- Identification: p-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline
Test substance storage: In refrigerator (2-8ºC) in the dark
Stability under storage conditions: Stable
Molecular formula: C15H19NO4
Molecular weight: 277.3
CAS Number: 5026-74-4
EC Number: 225-716-2
Description: Yellow liquid
Purity: 94.33%
Constituent 1
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
Volatile: No
Stability in water: No
Solubility in water: No
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Samples for analysis were taken from all test concentrations and the control. The method of analysis is described in the appended Analytical Report.
Sampling :
- Frequency of renewal: At the beginning and at the end of four intervals of 48 hours (nominal days 0 and 2, 6 and 8, 12 and 14, 18 and 20)
- Volume: 2 ml
- Storage: Samples were stored in a freezer until analysis.
At the end of the refreshment period, the replicates were pooled at each concentration before sampling.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- Preparation of test solutions started with a loading rate of 10 mg/l applying two days of magnetic stirring to reach maximum solubility of the test substance in the test medium. The resulting aqueous mixture was left to stabilize for 1-1.5 hours where after the Water Accommodated Fraction (WAF) was siphoned off and used as the highest test concentration. All lower test concentrations were prepared by subsequent dilutions of the WAF in test medium.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Species: Daphnia magna (Crustacea, Cladocera) (Straus, 1820), at least third generation, obtained by acyclical parthenogenesis under specified breeding conditions.
Source: In-house laboratory culture with a known history.
Reason for selection: This system has been selected as an internationally accepted invertebrate species.
Validity of batch: Daphnids originated from a healthy stock, 2nd to 5th brood, showing no signs of stress such as mortality >20%, presence of males, ephippia or discoloured animals and there was no delay in the production of the first brood.
Characteristics: To initiate the test, young daphnids < 24 hours old were selected, from parental daphnids greater than two weeks old.
Start of each batch : With newborn daphnids, i.e. less than 3 days old, by placing them individually in 50 ml M7-medium.
Maximum age of the cultures : 4 weeks
Temperature of medium : 18-22°C
Medium : M7, as prescribed by Dr. Elendt-Schneider (Elendt, B.-P., 1990: Selenium deficiency in Crustacea. An ultrastructural approach to antennal damage in Daphnia magna Straus. Protoplasma 154, 25-33).
Light : 16 h photoperiod daily;
intensity at the start: 624-708 lux (8.8-10 μE.m-2.s-1)
intensity at the end: 612-710 lux (8.8-9.9 μE.m-2.s-1)
Feeding : Daily, 0.5 ml of Chlorella pyrenoidosa suspension containing 0.40-0.54 x108 cells/ml was added as feed for the daphnids. This daily ration corresponded to 0.2 mg C/Daphnia/day, which is the recommended value for daily feeding per daphnid in the reproduction test according to the OECD Guideline 211.
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 21 d
- Remarks on exposure duration:
- Frequency of renewal: Every 48 hours
- Post exposure observation period:
- None
Test conditions
- Hardness:
- Total hardness varied between 179 and 214 mg calcium carbonate per litre, and thus complied to the requirements as laid down in the protocol (>140 mg CaCO3 per liter).
- Test temperature:
- The temperatures in the test media varied between 19.4 and 20.5°C. The temperature continuously measured in a temperature control vessel varied between 19.3 and 20.3°C during the test, and complied with the requirements as laid down in the protocol (18-22°C, constant within 2°C).
- pH:
- The pH remained within the range of 7.5 to 8.4 throughout the test and thus was maintained within the limits prescribed by the protocol (6.0-9.0, constant within 1.5 units).
- Dissolved oxygen:
- The oxygen concentration in all test solutions remained within the range of 8.2 to 9.7 mg/l during the exposure period and thus complied to the requirements as laid down in the protocol (>3 mg/l).
- Salinity:
- -
- Nominal and measured concentrations:
- Nominal concentrations: 1.0, 3.2, 10, 32 and 100% of a WAF prepared at a loading rate of 10 mg/l
Measured concentrations: Analysis of the sample taken from the WAF prepared at 10 mg/l at the start of four renewal periods showed that the actual test concentration ranged between 4.2 and 6.6 mg/l. Test concentrations slightly decreased during the 48 hour renewal periods (to 70-82% of initial). Test concentrations containing 10 and 32% of the WAF proved to have been prepared properly and also slightly decreased during the 48 hour renewal periods (to 63-79% of initial. The test concentration containing 1.0% of the WAF was below the lowest calibration standard at all times, while the test concentration containing 3.2% of the WAF varied between being below or just above the lowest calibration solution. Given these results effect parameters were based on the average exposure concentrations: 0.040, 0.096, 0.42, 1.7 and 4.8 mg/l. - Details on test conditions:
- Test duration: 21 days
Test type: Semi-static
Frequency of renewal: Every 48 hours
Test vessels: Volume: 60 ml (6 x Ø 3.5 cm), all-glass covered with a Perspex plate.
Medium: M7
Experimental design: At the start of the experiment (nominal day 0) 10 neonate daphnids, less than one day old, per group were divided over ten vessels each containing a minimum of 50 ml test medium. The control group consisted of 20 daphnids.
Light: 16 h photoperiod daily;
intensity at the start: 624-708 lux (8.8-10 µE.m-2.s-1)
intensity at the end: 612-710 lux (8.8-9.9 µE.m-2.s-1)
Feeding: Daily, 0.5 ml of Chlorella pyrenoidosa suspension containing 0.40-0.54 x10E8 cells/ml was added as feed for the daphnids. This daily ration corresponded to 0.2 mg C/Daphnia/day, which is the recommended value for daily feeding per daphnid in the reproduction test according to the OECD Guideline 211. - Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 21 d
- Dose descriptor:
- LC50
- Effect conc.:
- > 4.8 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Remarks:
- (Parental mortality)
- Remarks on result:
- other: -
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 4.8 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Remarks:
- (Parental mortality)
- Remarks on result:
- other: -
- Duration:
- 21 d
- Dose descriptor:
- EC50
- Effect conc.:
- 1.4 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: 0.91 - 2.2 mg/L
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 1.7 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: -
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.42 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: -
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- > 4.8 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: Body length
- Remarks on result:
- other: -
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 4.8 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: Body length
- Remarks on result:
- other: -
- Details on results:
- Condition of parental daphnids :
Three out of the twenty parental daphnids in the control died during the test period. Hence, parental mortality did not exceed 20% in the control. Mortality in all p-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline concentrations tested was lower or slightly higher than in the control but not statistically significant (Fisher’s exact test, α=0.05).
In the control group, the presence of eggs in the brood pouch was recorded for the first time on day 4-6 and the first brood appeared between day 7 and day 9. The first recording of the presence of eggs in the brood pouch was similar to the control in treated solutions up to and including 4.8 mg/l. Hence, no delay in appearance of the first brood was observed in the treatments when compared to the control.
Reproduction:
The average cumulative number of young per female in the control group after 21 days was 136 with a coefficient of variation of 11%. The reproduction curves recorded at 0.040, 0.096 and 0.42 mg/l closely followed the curve of the control. The curve recorded at 1.7 mg/l stayed behind from the start and daphnids exposed to 4.8 mg/l did not reproduce at all. There were some recordings of immobile young and/or aborted eggs in the control and the three lowest test concentrations, while significant amounts of aborted eggs were recorded at the two highest test concentrations throughout the 21-day test period. Statistical analysis showed that the reproduction of the daphnids was significantly reduced at 1.7 mg/l and higher (Bonferroni t-Test, α=0.05).
Statistical analysis of the data on body length was not needed as the % reduction recorded was not biologically significant (<10%). - Results with reference substance (positive control):
- -
- Reported statistics and error estimates:
- Statistical analysis:
Parental survival on day 21 was statistically tested using Fisher’s exact test (TOXSTAT Release 3.5, 1996, D.D. Gulley, A.M. Boelter, H.L. Bergman). Total reproduction on day 21 was tested for normality and for homogeneity of variance and statistically tested using an ANOVA test followed by a mean comparison test (Bonferroni t-Test, TOXSTAT Release 3.5, 1996). The respective threshold levels of effect (LOEC) and the respective NOECs were determined on basis of these statistics.
EC-values:
The 21d-EC50 for reproduction was based on log-linear regression analysis of the percentages of reproductive reduction versus the logarithms of the corresponding average exposure concentrations of the test substance.
Any other information on results incl. tables
-
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- p-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline did not affect reproduction of Daphnia magna at an average concentration of 0.42 mg/l after 21 days of exposure (NOEC).
Exposure to average concentrations of 1.7 mg/l and higher induced significant inhibition of the reproductive capacity of the parental daphnids (LOEC). The 21d-EC50 for reproduction was calculated to be 1.4 mg/l with a 95% confidence interval ranging from 0.91 to 2.2 mg/l. - Executive summary:
Exposure to average concentrations of 1.7 mg/l and higher induced significant inhibition of the reproductive capacity of the parental daphnids (LOEC). The 21d-EC50 for reproduction was calculated to be 1.4 mg/l with a 95% confidence interval ranging from 0.91 to 2.2 mg/l.
Also it was concluded that p-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline did not affect reproduction of Daphnia magna at an average concentration of 0.42 mg/l after 21 days of exposure (NOEC).
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