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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-928-6 | CAS number: 112-02-7
- 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://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_ecotoxicological-information.png)
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- From 11 March 1988 to 13 March 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- Refer to the Quaternary ammonium salts (QAS) category or section 13 of IUCLID for details on the category justification.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- no
- Details on sampling:
- A clear stock solution of 3.03 mg/mL was prepared by diluting 0.0303 g of the test substance with distilled water in a 10 mL flask. The test solutions were prepared by adding the appropriate volume of stock solution to dilution water to total 1,000 mL. Each solution was mixed on a magnetic stirrer for 30 seconds and then divided into 4 beakers to provide replicate exposure treatments, each containing 200 mL. The remaining 200 mL of test solution were used for 0 h water quality measurement.
- Vehicle:
- yes
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Name of vehicle: Water
- Concentration of vehicle in test medium (stock solution): Stock solution of 3.03 mg/mL was prepared by diluting 0.0303 g of the test substance with distilled water in a 10 mL flask - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Species: Daphnia magna
- Source: Springborn Life sciences, Inc., Wareham, Massachusetts
- Age at study initiation (mean and range, SD): ≤24 h
- Feeding during test: No
ACCLIMATION
- Acclimation period: Cultures of the test organism over many generation has been continuously maintained at the lab
- Acclimation conditions (same as test or not): Yes
- Type and amount of food: Solution of green algae and yeast suspension daily
- Feeding frequency: Daily - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Hardness:
- 180 mg/L as CaCO3
- Test temperature:
- 20-21⁰C
- pH:
- 7.9-8.3
- Dissolved oxygen:
- 98-99%
- Nominal and measured concentrations:
- 0, 236, 394, 667, 1,091, 1,818 and 3,030 µg/L as nominal concentration
- Details on test conditions:
- The test was conducted in 250 mL glass beaker. A clear stock solution of 3.03 mg/mL was prepared by diluting 0.0303 g of the test substance with distilled water in a 10 mL flask. The test solution was prepared by adding the appropiate volume of stock solution to dilution water to a total volume of 1 L. Each solution was mixed on a magnectic stirrer for 30 seconds and then divided into 4 beakers to provide replicate exposure treatments, each containing 200 mL. The remaining 200 mL of test solution was used for 0 hour water quality measurement and then discarded. One set of 4 control beakers was prepared containing the same dilution water and maintained under the same conditions as the exposure concentration, but without the test subsatnce. The ambient air temperature was controlled in order to maintain test solution temperature at 20 ± 1⁰C. The test solution was not aerated. The test area was illuminated with Sylvania GRO-LUX and cool white fluorescent lights at an intensity of 70 footcandles at the solution surface.
See below tables for detials. - Reference substance (positive control):
- no
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- 550 µg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 280 µg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Remarks on result:
- other: i.e., equivalent to 92.4 µg a.i. /L)
- Key result
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- < 236 µg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: mortality, behavioural and physical abnormalities
- Remarks on result:
- other: i.e., equivalent to 78 µg a.i. /L)
- Details on results:
- The 48 h EC50 and 95% confidence interval (calculated by probit analysis) was 280 (i.e. 92.4 ug a.i./L). The NOEC was <236 µg/L (<78 ug a.i./L), the lowest tested concentration.
- Validity criteria fulfilled:
- yes
- Conclusions:
- Based on the results of the read across study, the 48 h EC50 and NOEC for the test substance are considered to be at 280 and <236 µg/L, (i.e., equivalent to 0.09 and <0.08 mg a.i./L), respectively
- Executive summary:
A study was conducted to determine the acute toxicity study of the read across substance, Coco TMAC (33% active in water), to the Daphnia magna according to a method similar to OECD Guideline 202, in compliance with GLP. Daphnia magna (10 per dose) were exposed to the read across substance at nominal concentrations of 0, 236, 394, 667, 1,091, 1,818 and 3,030 µg/L for 48 h under static conditions and mortalities were determined. No analytical determination of the read across substance was performed. Throughout the test period no visible sign of undissolved material was observed in the exposure solutions. Immobilisation was determined after 24 and 48 h. Through-out the 48-h exposure all organisms which were not immobilized appeared normal as compared to the control daphnids i.e., behavior and physical appearance. The 48 h EC50 and 95% confidence interval were calculated by probit analysis as 280 (250 - 300) µg/L. The NOEC was < 236 µg/L, the lowest tested concentration. Under the study conditions, the 48 h EC50 and NOEC were 280 and <236 µg/L, (i.e., equivalent to 0.093 and <0.08 mg a.i./L), respectively (Surprenant, 1988). Based on the results of the read across study, similar effect levels are considered for the test substance.
Reference
Table 1: Immobilisation data
Test-Substance Concentration [µg a.i./l] |
|
||||||
ImmobileDaphnia |
|
|
|
||||
Number
24 h 48 h |
Percentage
24 h 48 h |
Oxygen [mg/l] 48 h |
pH
48 h |
Temperature [°C] 48 h |
|||
0 |
0 |
0 |
0 |
0 |
8.4 |
8.4 |
not known |
79 |
0 |
4 |
0 |
20 |
8.9 |
8.5 |
|
131 |
1 |
19 |
5 |
95 |
9.0 |
8.5 |
|
222 |
17 |
20 |
85 |
100 |
9.0 |
8.5 |
|
364 |
20 |
20 |
100 |
100 |
- |
- |
|
606 |
20 |
20 |
100 |
100 |
- |
- |
|
1010 |
20 |
20 |
100 |
100 |
- |
- |
|
Table 2: Effect data
|
EC501 |
95 % c.l. |
EC01 |
EC1001 |
24 h [µg a.i./l] |
183 (n) |
130-223 |
- |
- |
48 h [µg a.i./l] |
93 (n) |
83-100 |
< 79 (n) |
- |
1indicate if effect data are based on nominal (n) or measured (m) concentrations
Table 3: Validity criteria for acute daphnia immobilistaion test according to OECD Guideline 202
|
fulfilled |
Not fullfilled |
Immobilisation of control animals <10% |
YES |
|
Control animals not staying at the surface |
YES |
|
Concentration of dissolved oxygen in all test vessels >3 mg/l |
YES |
|
Concentration of test substance³80% of initial concentration during test |
* |
|
* Not known for no analyses were performed
Description of key information
Therefore, in line with the biocides assessment report and as a conservative approach, the same 48 h EC50 value of 0.012 mg a.i./L (nominal) based on read across to C12 -16 ADBAC has been considered further for hazard/risk assessment.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Dose descriptor:
- EC50
- Effect concentration:
- 12 µg/L
Additional information
A study was conducted to determine the acute toxicity study of the read across substance, Coco TMAC (33% active in water), to theDaphniamagna according to a method similar to OECD Guideline 202, in compliance with GLP.Daphniamagna (10 per dose) were exposed to the read across substance at nominal concentrations of 0, 236, 394, 667, 1,091, 1,818 and 3,030 µg/L for 48 h under static conditions and mortalities were determined. No analytical determination of the read across substance was performed. Throughout the test period no visible sign of undissolved material was observed in the exposure solutions. Immobilisation was determined after 24 and 48 h. Through-out the 48-h exposure all organisms which were not immobilized appeared normal as compared to the control daphnids i.e., behavior and physical appearance. The 48 h EC50 and 95% confidence interval were calculated by probit analysis as 280 (250 - 300) µg/L. The NOEC was < 236 µg/L, the lowest tested concentration. Under the study conditions, the 48 h EC50 and NOEC were 280 and <236 µg/L (nominal; i.e., equivalent to 0.093 and <0.08 mg a.i./L), respectively (Surprenant, 1988).
The biocide assessment report available from RMS Italy on Coco TMAC (ECHA assessment report, 2016), considered the above study to be supportive because the endpoints were based on nominal concentrations, which could underestimate the toxicity. However, similar to the fish endpoint, several available reliable read across studies with DDAC and BKC, also indicated toxicity in the same range. From the Lonza Cologne GmbH dossier, the RMS retrieved a read across data to DDAC as 48h EC50 = 0.062 mg a.s./L, calculated as 48h EC50 = 0.047 mg a.s./L upon correction for MW, and from the Akzo Nobel Surface Chemistry AB dossier, a read across data to C12-16-BKC (or C12-16 ADBAC) of 48h EC50 = 0.016 mg a.s./L, calculated as 48h EC50 = 0.012 upon correction for MW. The two read across endpoints were considered to be equally reliable, but the RMS selected the read across data to C12-16 ADBAC with the lowest 48 h EC50 = 0.016 mg a.i./L, as the worst case and calculated the 48 h EC50 for Coco TMAC at 0.012 mg a.i./L by applying correction for MW.
Therefore, in line with the biocides assessment report and as a conservative approach, the same 48 h EC50 value of 0.012 mg a.i./L based on read across to Coco TMAC / C12-16 ADBAC has been considered further for hazard/risk assessment.
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)