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EC number: 262-134-8 | CAS number: 60270-33-9
- 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
Endpoint summary
Administrative data
Description of key information
Additional information
For the assessment of aquatic toxicity of DIMAPDO short-term toxicity data of DIMAPDO lactate with fish, aquatic invertebrates, algae and microorganisms are available.
Short-term toxicity to fish
In a 96-h acute toxicity study according to OECD guideline 203 (Fish, Acute Toxicity Test; 1992) and EU Method C.1 (Acute Toxicity for Fish; 1992), juvenile rainbow trouts (Oncorhynchus mykiss) were exposed to DIMAPDO lactate at nominal concentrations of 1.0, 1.8, 3.2, 5.6 and 10 mg test substance/L (mean measured concentrations of untreated test medium: 0.63, 1.5, 2.9, 4.8 and 9.1 mg/L; mean measured concentrations of centrifuged test medium: 0.32, 0,76, 1.2, 2.6 and 6.6 mg/L) under semi-static conditions. The 96-hour LC50 based on nominal test concentrations was 7.5 mg/L with 95% confidence limits of 5.6 - 10 mg/L. The 96-hour LC50 based on mean measured concentrations of untreated test medium was 6.6 mg/L with 95% confidence limits of 4.8 - 9.1 mg/L.
Because the study was conducted with the lactic acid salt of DIMAPDO, the 96-h LC50 and the NOEC value of DIMAPDO based on mortality and sublethal effects and the concentration analysis of the untreated test solution were calculated as 5.45 mg/L and 3.96 mg/L active ingredient, respectively.
Sub-lethal effects (moribundity) of exposure were observed at a nominal test concentration of 10 mg/L. Due to the approach of substantial severity limit these fish were killed and classed as mortalities at 24 and 48-hour time points respectively.
Short-term toxicity to aquatic invertebrates
The 48-hr-acute toxicity of DIMAPDO lactate to Daphnia magna was studied under semi-static conditions according to OECD guideline 202 (April 13, 2004) and Daphnia sp., Acute Immobilization Test stipulated in the "Testing Methods for New Chemical Substances" (November 21, 2003; No. 1121002, Pharmaceutical and Food Safety Bureau, MHLW). Daphnids were exposed to control, and test chemical at measured concentrations of untreated test solution of 0.245, 0.497, 0.999, 1.99, 3.74, 7.82 mg test substance/L for 48 hr.
Mortality/immobilization and sublethal effects were observed daily. The 48-hour EC50 was 1.41 mg test substance/L. The 48-hr NOEC based on immobilization was 0.497 mg test substance/L. Because the study was conducted with lactic acid salt of DIMAPDO the EC50 and NOEC values of DIMAPDO based on % immobilization were calculated as 1.16 mg/L and 0.41 mg/L active ingredient.
Toxicity to aquatic algae and cyanobacteria
In a 72 hours toxicity study, the cultures of Scenedesmus subspicatus were exposed to DIMAPDO lactate at nominal concentrations of 1.0, 2.0, 4.0, 8.0 and 16 mg/L under static conditions in accordance with the OECD guideline 201 (1984) and EU Method C.3 (Algal Inhibition test; Commission Directive 92/69/EEC). The % growth inhibition in the treated algal culture as compared to the control ranged from 2% to 107%.
The NOEC and EC50 values based on % growth inhibition were 1.0 and 2.7 mg/L, respectively. Based on the geometric mean measured test concentrations of the untreated test media the EC50 was 2.1 mg/L and the NOEC was 0.44 mg/L.
The study was conducted with the lactic acid salt of DIMAPDO. Therefore the EC50 and NOEC values of DIMAPDO based on % growth inhibition and the test concentrations of untreated media were calculated as 1.73 mg/L and 0.36 mg/L active ingredient.
The following abnormalities were noted: After 72 hours there were no abnormalities detected in the control or test cultures at 1.0 mg/L, however some enlarged cells were observed to be present in the test cultures at 2.0, 4.0, 8.0 and 16 mg/L. The test material was observed to form a homogenous dispersion in culture medium.
Toxicity to microorganisms
The toxicity of DIMAPDO lactate (99.2% a.i.) to microorganisms was investigated during a ready biodegradation study according to EU Method C.4-C (Determination of the "Ready" Biodegradability - Carbon Dioxide Evolution Test; 1992) and OECD guideline 301 B, 1992 over a period of 28 days and using an inoculum obtained from activated sludge of a predominantly domestic sewage treatment plant. The biodegradation rate was determined by measurement of carbon dioxide evolution.
Inoculum blank, procedural/functional control with the reference substance Sodium benzoate and a toxicity control with reference substance (10 mg C/L) and test substance (9.17 mg C/L) were performed.
The biodegradation in the toxicity control was 81% after 14 d and 100% after 28 d. More than 25% biodegradation occurred within 14 days. Therefore, the test substance was assumed not to inhibit microbial activity at the tested concentration.
Because the study was conducted with the lactic acid salt of DIMAPDO, the 28 d NOEC based on respiratory activity was calculated to be 10.81 mg/L in terms of DIMAPDO.
Table 1: Acute and chronic ecotoxicity values for the registration substance DIMAPDO
Test type |
Guideline |
Species |
Endpoint |
Value |
Short-term toxicity to fish |
OECD 203, EU Method C.1 |
Oncorhynchus mykiss |
LC50 (96h) |
5.45 mg a.i./L |
Short-term toxicity to aquatic invertebrates |
OECD 202 |
Daphnia magna |
EC50 (48h) |
1.16 mg a.i./L |
Toxicity to aquatic algae and cyanobacteria |
OECD 201, EU Method C.3 |
Scenedesmus subspicatus (new name: Desmodesmus subspicatus) |
ErC50 (72h) NOEC |
1.73 mg a.i./L 0.36 mg a.i./L |
Toxicity to microorganisms |
OECD 301B, EU Method C.4 |
Activated sludge |
NOEC (28d) |
10.81 mg a.i./L |
Justification for not reporting studies performed with DIMAPDO lactate as read-across
All available aquatic toxicity studies were performed with DIMAPDO lactate. DIMAPDO lactate is an ionic chemical compound that dissociates in water under neutral pH conditions almost entirely into DIMAPDO and lactate. This is supported by the observation that at the start of the exposures the test solutions were usually clear and but within the first 24 hours the test solutions became cloudy dispersed solutions. DIMAPDO lactate with its good water solubility dissociates over time into the highly soluble lactate and the only slightly soluble DIMAPDO that forms small micelles in aqueous solutions. Therefore aquatic organisms are mainly exposed to DIMAPDO and lactate and not to DIMAPDO lactate.
Lactate is a normal metabolic intermediate produced and needed by most mammalian cells and micro-organisms and has a low aquatic toxicity (registered substances databank ECHA website). Therefore all toxic effects seen can be attributed to DIMAPDO.
Bowmer et al. published in 1998 a study where they compared the ecotoxicity of lactic acid and its alkyl esters experimentally with the micro alga Selenastrum capricornutum, the crustacean Daphnia magna and the fish species Danio rerio and Pimephales promelas. The results presented indicate that alkyl lactate esters show some differences in their ecotoxicity when compared to non polar narcotic compounds but that these differences are generally small. For example for octyl lactate the EbC50 for algae (72-96h) was 7.6 mg/L, the daphnia EC50 (48 h) was 41 mg/L and the fish LC50 (96 h) was 24 mg/L. These values are relatively similar to the values of octanol with an EbC50 for algae (72-96h) of 14.6 mg/L, a daphnia EC50 (48 h) of 31.8 mg/L and a fish LC50 (96 h) of 14 mg/L (registered substances database, ECHA website).
CONCLUSION:
Therefore under environmental conditions it is toxicologically not relevant if DIMAPDO or DIMAPDO lactate are introduced in an aquatic medium.
Test substance concentration analysis
As the test material was observed to form a dispersion in the test diluent, samples taken from the
test preparations were analysed untreated and after centrifugation (40000 g, 30 minutes) in order to give an indication of the dissolved test material concentration.
The analysed test concentrations of the untreated solution (analysis of dispersed + dissolved test substance) and not of the centrifuged solution (analysis only of dissolved test substance) were chosen as calculation basis for all tests because in the OECD guideline 201 study there was a discontinuity in the analysis of the concentrations of the centrifuged test solution and therefore the calculated values for the centrifuged test media were not valid. Additionally in the OECD guideline 203 study the examination of the dead fish revealed that the dispersed test material had adhered to the gill filaments indicating physical toxicity of the dispersed test material particles that may be also a factor for the toxicity observed in other organisms.
References:
C.T. Bowmer, R.N. Hooftman, A.O. Hanstveit, P.W.M. Venderbosch & N. van der Hoeven. The ecotoxicity and the biodegradability of lactic acid, alkyl lactate esters and lactate salts. Chemosphere, Vol. 37, No. 7, pp. 1317-1333, 1998
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