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EC number: 266-235-8 | CAS number: 66204-44-2
- 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:
- 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study according to guideline (OECD 211) in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Institut Fresenius
Test material
- Reference substance name:
- 3,3'-methylenebis[5-methyloxazolidine]
- EC Number:
- 266-235-8
- EC Name:
- 3,3'-methylenebis[5-methyloxazolidine]
- Cas Number:
- 66204-44-2
- Molecular formula:
- C9H18N2O2
- IUPAC Name:
- 3,3'-methylenebis[5-methyloxazolidine]
- Details on test material:
- - Test material: Reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio of 3:2)
- Lot-No. 1116148
- Specification: “Grotan Ox”, 3,3’-Methylenbis(5-methyloxazolidin)
- Colourless to yellowish liquid with an aminic odour, density 1.060 g/cm3
- Purity: Not applicable (reaction product)
- Composition of Product: Not applicable
- Further relevant properties: The stability of the test item under test conditions was tested during this study. The test item dissociates in the aqueous phase to release formaldehyde.
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Chemical analyses performed with the test solutions at the start of incubation and after 48 h (four times during the test duration).
Test solutions
- Details on test solutions:
- - The test solutions were prepared freshly every 2 days
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- - Strain / Clone: Daphnia magna STRAUS (clone 5)
- Source: Laboratory breed originally derived from BASF AG, Germany
- Age: < 24 h
- Breeding method: Animals were transferred in new test medium at an interval of 1 to 3 days followed by feeding
- Kind of food: Desmodesmus subspicatus- and/or Chlorella-cells
- Amount of food: 0.1-0.2 mg C/Daphnia
- Feeding frequency: Every 1 to 3 days
- Pretreatment: Daphnids transferred into fresh medium 1 day before starti of the test
- Feeding of animals during test: Yes (Desmodesmus subspicatus)
- Handling of offspring: Offspring animals were counted daily and were then eliminated from treatment.
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 21 d
Test conditions
- Test temperature:
- 19.6 – 22.6°C (mean 21.5°C)
- pH:
- 7.51 - 9.49
- Dissolved oxygen:
- 7.2 – 8.8 mg/L
- Nominal and measured concentrations:
- - Nominal concentrations: 50.0, 20.0, 8.0, 3.2, 1.28, 0.512 mg/L + control
- Concentrations ranging from 0.512 to 20.0 mg/L were monitored. Recovery values of formaldehyde are given in the table below. - Details on test conditions:
- TEST SYSTEM
- Renewal of test solution: every 2 days
- Volume of test vessels: 90 mL
- Volume/animal: 90 mL
- Number of animals/vessel: 1
- Number of vessels/ concentration: 13
TEST MEDIUM / WATER PARAMETERS
-Source: Elendt M4 medium, according to Guideline
- Salinity: Not applicable
- Ca / Mg ratio: according to Guideline
- Na / K ratio: according to Guideline
- Holding water different from dilution water: No
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Quality/Intensity of irradiation: Mean intensity 0.93 klx ≈ 14.0 µE/m2s
- Photoperiod: Day/night : 16 h / 8 h
TEST PARAMETER
- Mortality
- Number of living offspring produced per parent animal
- Intrinsic rate of population growth
- Age at first reproduction
- Size of the parent animals, measured in control and at 20 mg/L only at test end
SAMPLING AND EXAMINATION SCHEDULE
- Daily examination of biological parameters, except size of animals (at end of test)
- pH and oxygen content measured in freshly prepared test solutions and after 48 h
STATISTICS
- The statistical calculations were done using the commercial computer program ToxRatPro Version2.09 (08.11.2006) - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate (tested prior beginning of the test)
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 1.3 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Remarks:
- related to cumulative offspring of survivors
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 3.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Remarks:
- related to cumulative offspring of survivors
- Duration:
- 21 d
- Dose descriptor:
- EC10
- Effect conc.:
- 1.1 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Remarks:
- related to cumulative offspring of survivors
- Remarks on result:
- other: 95% CI: 0.0-3.0
- Duration:
- 21 d
- Dose descriptor:
- other: EC20
- Effect conc.:
- 3.3 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Remarks:
- related to cumulative offspring of survivors
- Remarks on result:
- other: 95% CI: 0.2-7.0
- Duration:
- 21 d
- Dose descriptor:
- EC50
- Effect conc.:
- 26.4 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Remarks:
- related to cumulative offspring of survivors
- Remarks on result:
- other: 95% CI: 11.6-1608
- Details on results:
- - For effects related to mobility, age of first reproduction, intrinsic rate of population growth, and size measurement see tables below.
- In the high-dose group (50 mg/L) all parental animals have died after day 4 - Results with reference substance (positive control):
- EC50 (mobility, 24h)=1.26 mg/L
Any other information on results incl. tables
Nominal Conc. [mg/L] |
No. offspring / living parent |
Dead parent animals |
control |
64.5 |
0 |
0.512 |
63.6 |
0 |
1.28 |
61.5 |
0 |
3.20 |
47.8 |
0 |
8.00 |
41.8 |
0 |
20.0 |
37.1 |
2 (after 6 d) |
50.0 |
0 |
13 (after 4 d) |
Effect values, related to mobility (95% CI):
NOEC |
8.0 mg/L |
LOEC |
20.0 mg/L |
EC10 |
11.4 mg/L (8.4-15.6) |
EC20 |
14.9 mg/L (11.3-19.7) |
EC50 |
24.9 mg/L (18.8-32.9) |
Effect values, related to age of first reproduction:
NOEC |
≥ 20 mg/L |
LOEC |
> 20 mg/L |
Effect values, related tointrinsic rate of population growth :
NOEC |
≥ 50 mg/L |
LOEC |
> 50 mg/L |
Size
measurements of parental animals at test end as percental difference
between 20 mg/L and non-treated control (negative value indicates, that
animals are larger):
3.17% (length)
-2.14% (diameter)
In conclusion, no test item related effects were observed for the additional parameters intrinsic rate of poupulation growth, age at first reproduction, and size of parantel animals at test end.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The substance was found to be harmful towards daphnids reproduction.
- Executive summary:
The substance was found to be harmful towards daphnids reproduction.The numerical results are given below; all results refer to the nominal concentrations since the formaldehyde content was shown to be stable within the incubation period.
A clear concentration-response relationship can be established from the study results. While at 1.3 mg/L no significant effectswere observed,reproduction was inhibited by >10% at 3.2 mg/L.
Test item related effects were found for the additional endpoints mobility (NOEC = 8.0 mg/L), intrinsic rate of population growth (NOEC > 50 mg/L), and age at first reproduction (NOEC > 20 mg/L). Length and diameter of the parent animals were not affected at 20 mg/L (determined after termination of exposure).
The constituents of the reaction product (substance) are not volatile from aqueous solutions, therefore this removal mechanism could not influence the test results.It is not expected that thethe low adsorptivity of the test substance influenced test substance concentrations. Possible substance losses due to biodegradation are unlikely in the semistatic system.
The constituents of the reaction product (substance) hydrolyse completely in concentrations which are expected to occur in waste waters and surface waters. Also in the media of toxicity tests, complete hydrolysis of the substance is expected, therefore the observed effects are assumed to be caused by a mixture of hydrolysis products.
Analysis of the formaldehyde content in the test solutions proved the test item to remain stable at >80% of the initial values over the respective 48 h inbubation period. For this reason, the results of this test are based on the nominal concentrations tested.
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