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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 812-491-6 | CAS number: 1312943-23-9
- 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
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:
- 07 December 2017 to 14 March 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Version / remarks:
- October 02, 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.20 (Daphnia magna Reproduction Test)
- Version / remarks:
- No. 440/2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: Control and 100 mg/L loading rate
- Sampling method: Duplicate samples were taken
- Sample storage conditions before analysis: The samples were stored frozen prior to analysis. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A nominal amount of test item (400 mg) was added to the surface of 4 litres of test water to give the 100 mg/L loading rate. After the addition of the test item, the test water was stirred by magnetic stirrer using a stirring rate such that a vortex was formed to give a dimple at the water surface. The stirring was stopped after 23 hours and the mixture allowed to stand for 1-Hour. The aqueous phase or WAF was removed by mid-depth siphoning (the first approximate 75 to 100 mL discarded) to give the 100 mg/L loading rate WAF.
Preliminary work was carried out to determine whether stirring for a prolonged period produced significantly higher measured test concentrations in the WAF. It was concluded that increasing the stirring period did not increase the amount of dissolved test item in the WAF between the 24-Hour and 96-Hour preparation periods and so preparation of the WAF was maintained at a 23-Hour stirring period followed by a 1-Hour standing period.
- Controls: Untreated test media
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): Microscopic inspection of the WAF showed no micro-dispersions or undissolved test item to be present - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Strain/clone: Not reported
- Source: In-house laboratory culture
- Age of parental stock (mean and range, SD): 1st instar < 24 hours old
- Feeding during test Yes
- Food type: Algal suspension and Tetramin® flake food suspension.
- Amount: 5 to 15 µL of an algal suspension (Desmodesmus subspicatus) and approximately 20 µL of Tetramin® flake food suspension daily. Feeding was at a level of approximately 0.1 to 0.2 mg carbon/daphnid/day, dependent on the age and size of the animals, with the exception of Day 0 when the concentrated algal suspension was used in error. Equal amounts of food were given to each daphnid.
- Frequency: Daily
ACCLIMATION
- Acclimation period:None
METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES: Gravid adults were isolated the day before initiation of the test, such that the young daphnids produced overnight were less than 24 hours old. These young were removed from the cultures and used for testing - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 21 d
- Post exposure observation period:
- None
- Hardness:
- 228 to 260 mg/L as CaCO3
- Test temperature:
- 19 - 21 °C
- pH:
- 7.7 to 8.4
- Dissolved oxygen:
- 7.8 - 9.5 mg/L
- Salinity:
- Not applicable
- Conductivity:
- Not reported
- Nominal and measured concentrations:
- Nominal loading rate: 100 mg/L
Measured: < LOQ - Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass vessel
- Type: closed
- Material, size, headspace, fill volume: 100 mL of the test preparation in 150 mL glass vessels which were then covered with a plastic lid to reduce evaporation
- Aeration: No
- Type of flow-through (e.g. peristaltic or proportional diluter): Not applicable
- Renewal rate of test solution (frequency/flow rate): Three times per week
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Elendt M7 media prepared according to guideline
- Total organic carbon: Not reported
- Culture medium different from test medium: No
- Intervals of water quality measurement: Dissolved oxygen concentrations, pH and temperature were recorded before and after each test media renewal. The temperature was also measured every hour in one replicate of the control. The water hardness of the control and the highest test concentration in the fresh and old media was measured once per week, with the exception of the first week when no old sample was taken in error.
OTHER TEST CONDITIONS
- Adjustment of pH: None
- Photoperiod: 16 hours light and 8 hours darkness with 20 minute dawn and dusk transition periods
- Light intensity: 674 - 952 Lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : On a daily basis the numbers of live and dead of the "Parental" (P1) generation, the numbers of live and dead "Filial" (F1) Daphnia and the number of discarded unhatched eggs were counted. An assessment was also made of the general condition and size of the parental daphnia as compared with the controls. At the end of the test, the length of each surviving parent animal was determined
TEST CONCENTRATIONS
- Spacing factor for test concentrations: Not applicable
- Range finding study: Yes
- Test concentrations: 1.0, 10 and 100 mg/L loading rates
- Results used to determine the conditions for the definitive study: Yes - Reference substance (positive control):
- not specified
- Duration:
- 21 d
- Dose descriptor:
- EL50
- Remarks:
- Paternal generation
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- immobilisation
- Duration:
- 21 d
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Duration:
- 21 d
- Dose descriptor:
- NOELR
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Details on results:
- - Behavioural abnormalities: None reported
- Observations on body length and weight: After 21 days the length of each surviving adult was determined. The results showed that there were no statistically significant differences (P=0.05) between the control and the 100 mg/L test group in terms of length of the daphnids after 21 days exposure to the test item.
- Other biological observations: None reported
- Mortality of control: 0
- Other adverse effects control: None reported
- Abnormal responses: None reported
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: None reported; After siphoning and for the duration of the test, the control and 100 mg/L loading rate WAF test group were observed to be clear, colourless solutions. - Reported statistics and error estimates:
- An estimate of the 21-Day EL50 value was given by inspection of the immobilization data. The EL50 (reproduction) value after 21 days was estimated by inspection of the data. For the estimation of the LOEL and the NOEL, the numbers of live young produced per adult over the duration of the test for the control and 100 mg/L test group were compared using a Two-sample t-test Procedure. Results from the control and 100 mg/L test group daphnia length data, determined for the surviving daphnids on termination of the test, were compared using a Two-sample t-test Procedure.
- Validity criteria fulfilled:
- yes
- Remarks:
- Control mortality 0%; Mean number of live young (control): 173; coefficient of variation (control): 7%; No ephippia produced: 0; dissolved oxygen: >=7.8 mg/L; pH (control): 7.7 - 8.4 (variation 0.7)
- Conclusions:
- The 21-Day EL50 (immobilization) value for the parental daphnia generation (P1) and the 21-Day EL50 (reproduction) were > 100 mg/L, based on nominal loading rates. The No Observed Effect Loading Rate based on nominal loading rates was 100 mg/L, the only concentration tested.
- Executive summary:
The long-term toxicity of the test item to Daphnia magna was determined in a study following OECD 211 and EC C.20 guidelines. The study was conducted as a limit test at a nominal loading rate of 100 mg test item/L, prepared as a water accommodated fraction, based on the results of a preliminary study. Test solutions were renewed 3 times per week. On a daily basis the numbers of live and dead of the "Parental" (P1) generation, the numbers of live and dead "Filial" (F1) Daphnia and the number of discarded unhatched eggs were counted. An assessment was also made of the general condition and size of the parental daphnia as compared with the controls. At the end of the test, the length of each surviving parent animal was determined. The 21-Day EL50 (immobilization) value for the parental daphnia generation (P1) and the 21-Day EL50 (reproduction) were > 100 mg/L, based on nominal loading rates. The No Observed Effect Loading Rate based on nominal loading rates was 100 mg/L, the only concentration tested. Given that the toxicity cannot be attributed to a single component or a mixture of components, but to the test substances as a whole, and the dissolved concentrations were below the quantifiable limit of the analytical method, the results are reported based on nominal loading rates only.
The study is a GLP compliant, guideline experimental study and is fully acceptable for assessment of this endpoint.
Reference
Table 1: Range-finding Test data
Nominal Loading Rate (mg/L) |
Percentage Immobilisation After 10 Days Exposure | Sub-lethal Effects | Total Number of Live Young |
Control | 0 | None | 129 |
1.0 | 0 | None | 126 |
10 | 0 | None | 134 |
100 | 0 | None | 132 |
Table 2: Summary of finding following the expousre of Daphnia magna for 21 days
Nominal Loading Rate (mg/L) |
Parental (P1) Generation Motalities (Initial population = 10) |
Total Number of Live Young |
Number of Live Young from Parents Surviving to the End of the Test |
Number of Live Young at the End of the Test Excluding Parents that were Accidental or Inadvertent Mortalities |
||||
Total |
Accidental |
Inadvertant |
Total |
Average per Parent |
Total |
Average per Parent |
||
Control |
0 |
0 |
0 |
1730 |
1730 |
173 |
1730 |
173 |
100 |
0 |
0 |
0 |
1626 |
1626 |
163 |
1626 |
163 |
Table 3: Summary of Observations in the Definitive Test
Day |
Nominal Loading Rate |
|||
Control |
100 mg/L |
|||
Adults Surviving |
Live Young |
Adults Surviving |
Live Young |
|
1 |
10 |
0 |
10 |
0 |
2 |
10 |
0 |
10 |
0 |
3 |
10 |
0 |
10 |
0 |
4 |
10 |
0 |
10 |
0 |
5 |
10 |
0 |
10 |
0 |
6 |
10 |
0 |
10 |
0 |
7 |
10 |
0 |
10 |
0 |
8 |
10 |
157 |
10 |
145 |
9 |
10 |
0 |
10 |
0 |
10 |
10 |
0 | 10 | 0 |
11 | 10 | 300 | 10 | 298 |
12 | 10 | 0 | 10 | 0 |
13 | 10 | 0 | 10 | 115 |
14 | 10 | 432 | 10 | 286 |
15 | 10 | 0 | 10 | 0 |
16 | 10 | 0 | 10 | 0 |
17 | 10 | 457 | 10 | 441 |
18 | 10 | 0 | 10 | 0 |
19 | 10 | 0 | 10 | 0 |
20 | 8 | 384 | 10 | 341 |
21 | 8 | 0 | 10 | 0 |
TOTALS | 8 | 1730 | 10 | 1626 |
Table 4: Total cumulative production of Live Young
Nominal Loading Rate (mg/L) | Day |
||||||||||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
16 |
17 |
18 |
19 |
20 |
21 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
157 |
157 |
157 |
457 |
457 |
457 |
889 |
889 |
889 |
1346 |
1346 |
1346 |
1730 |
1730 |
100 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
145 |
145 |
145 |
443 |
443 |
558 |
844 |
844 |
844 |
1285 |
1285 |
1285 |
1626 |
1626 |
Table 5: Body Length of Surviving Adults at Day 21
Nominal Loading Rate (mg/L) |
Individual Daphnia Lengths (mm) |
|||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
|
Control |
4.5 |
4.5 |
4.5 |
4.4 |
4.5 |
4.4 |
4.4 |
4.5 |
4.4 |
4.4 |
100 |
4.5 |
4.3 |
4.4 |
4.4 |
4.5 |
4.5 |
4.6 |
4.3 |
4.1 |
4.4 |
Table 6: Water Quality Measurements
Nominal Loading Rate (mg/L) |
|
Day |
||||||||||||||
0 |
1 |
2* |
2+ |
3 |
4* |
4+ |
5 |
6* |
6+ |
7 |
8 |
8 |
9 |
10 |
||
Control |
mg O2/L |
8.7 |
- |
9.4 |
8.9 |
- |
9.0 |
8.8 |
- |
9.2 |
8.9 |
- |
9.2 |
8.9 |
- |
- |
pH |
8.0 |
- |
8.4 |
8.1 |
- |
8.1 |
7.9 |
- |
8.0 |
8.0 |
- |
8.0 |
8.0 |
- |
- |
|
Temperature (°C) |
21 |
20 |
20 |
21 |
20 |
21 |
21 |
21 |
20 |
21 |
20 |
20 |
20 |
20 |
20 |
|
100 |
mg O2/L |
8.7 |
- |
9.2 |
8.7 |
- |
9.0 |
8.7 |
- |
9.2 |
8.9 |
- |
9.3 |
8.9 |
- |
- |
pH |
8.1 |
- |
8.3 |
8.1 |
- |
8.1 |
8.0 |
- |
8.1 |
8.0 |
- |
8.0 |
8.0 |
- |
- |
|
Temperature (°C) |
21 |
20 |
20 |
21 |
20 |
21 |
21 |
20 |
20 |
21 |
20 |
20 |
21 |
20 |
20 |
Nominal Loading Rate (mg/L) |
|
Day |
|||||||||||||||
11* |
11+ |
12 |
13* |
13+ |
14 |
15* |
15+ |
16 |
17 |
18* |
18+ |
19 |
20* |
20+ |
21 |
||
Control |
mg O2/L |
9.5 |
9.0 |
- |
8.9 |
9.0 |
- |
8.4 |
8.7 |
- |
- |
8.4 |
8.5 |
- |
7.8 |
8.8 |
8.5 |
pH |
8.2 |
8.0 |
- |
8.0 |
7.9 |
- |
7.8 |
7.7 |
- |
- |
7.9 |
8.0 |
- |
7.8 |
7.8 |
8.0 |
|
Temperature (°C) |
19 |
20 |
20 |
20 |
20 |
19 |
20 |
20 |
20 |
20 |
20 |
21 |
20 |
20 |
21 |
20 |
|
100 |
mg O2/L |
9.4 |
8.9 |
- |
9.0 |
8.9 |
- |
8.5 |
8.7 |
- |
- |
8.4 |
8.5 |
- |
8.0 |
8.6 |
8.4 |
pH |
8.0 |
8.0 |
- |
8.1 |
8.0 |
- |
7.8 |
7.9 |
- |
- |
7.9 |
8.0 |
- |
7.8 |
7.9 |
7.9 |
|
Temperature (°C) |
19 |
20 |
20 |
20 |
21 |
19 |
20 |
21 |
20 |
20 |
20 |
21 |
20 |
20 |
21 |
20 |
* Before renewal
+ After renewal
- Not required
Table 7: Results for Test samples
Time Point (Day) |
Nominal Loading Rate cnom (mg/L) |
Sample Prepartion Factor F |
Determined Concentration of Test Item in Test sample c (mg/L) |
0 |
Control |
0.1 |
<LOQ |
Fresh |
100 |
0.1 |
<LOQ |
4 |
Control |
0.1 |
<LOQ |
Fresh |
100 |
0.1 |
<LOQ |
6 |
Control |
0.1 |
<LOQ |
Old |
100 |
0.1 |
<LOQ |
11 |
Control |
0.1 |
<LOQ |
Fresh |
100 |
0.1 |
<LOQ |
13 |
Control |
0.1 |
<LOQ |
Old |
100 |
0.1 |
<LOQ |
20 |
Control |
0.1 |
<LOQ |
Fresh |
100 |
0.1 |
<LOQ |
21 |
Control |
0.1 |
<LOQ |
Old |
100 |
0.1 |
<LOQ |
Description of key information
The long-term toxicity to Daphnia magna has been assessed for one substance within the MDI category definition. The study was conducted using a water accommodated fraction as the test item is a poorly soluble UVCB. The determined EL50 values, based on parental mortality and reproduction, were >100 mg/L, with a NOELR value of 100 mg/L, the only concentration tested. Based on these results, members of the MDI category are not expected to be toxic to aquatic invertebrates at the limit of solubility.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 100 mg/L
Additional information
A study was performed to assess the long-term toxicity of the Reaction product of 4,4'-methylenediphenyl diisocyanate and amines, coco alkyl to Daphnia magna (Ablitt 2018). The results from this study are read across to other members of the polyurea MDI category.
The method followed was designed to be compatible with the OECD guideline 211, "Daphnia magna, Reproduction Test". Following preliminary range-finding tests, ten daphnids (ten replicates of one animal) were exposed to a Water Accommodated Fraction (WAF), at a single nominal loading rate of 100 mg/L, with test media renewal three times per week. The stirring period for the WAF preparation was validated in a preliminary study before the main test. The study was conducted with 21 days exposure at a temperature of 19°C to 21°C. Chemical analysis of the freshly prepared test preparations on Days 0, 4, 11 and 20, and of the old or expired media on Days 6, 13 and 21 was conducted and showed measured test concentrations of less than the LOQ of the analytical method employed were obtained which was determined to be 0.00060 mg/L. On a daily basis the numbers of live and dead of the "Parental" (P1) generation, the numbers of live and dead "Filial" (F1) Daphnia and the number of discarded unhatched eggs were counted. An assessment was also made of the general condition and size of the parental Daphnia as compared with the controls. At the end of the test, the length of each surviving parent animal was determined.
The 21-Day EL50 (immobilization) value for the parental daphnia generation (P1) and the 21-Day EL50 (reproduction) were > 100 mg/L, based on nominal loading rates. The No Observed Effect Loading Rate based on nominal loading rates was 100 mg/L, the only concentration tested. Given that the toxicity cannot be attributed to a single component or a mixture of components, but to the test substance as a whole, and the dissolved concentrations were below the quantifiable limit of the analytical method, the results were based on nominal loading rates only.
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.