Registration Dossier
Registration Dossier
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: 296-566-3 | CAS number: 92797-30-3
- 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

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 from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Refer to analogue justification provided in IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Duration:
- 48 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: Water Accommodated Fraction (WAF)
- Basis for effect:
- mobility
- Remarks on result:
- other:
- Remarks:
- Source: Key, source, RA-A, CAS 95912-87-1, BASF, 2001, D. magna, 48 h, RL1
- Duration:
- 48 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: Water Accommodated Fraction (WAF) + Emulsifier
- Basis for effect:
- mobility
- Remarks on result:
- other:
- Remarks:
- Source: Key, source, RA-A, CAS 95912-87-1, BASF, 2001, D. magna, 48 h, RL1
- Conclusions:
- The retained effect concentration for the short-term toxicity to aquatic invertebrates is an EL50 (48 h) of > 100.0 mg/L (nominal, EU Method C.2./OECD 202, read-across).
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- yes
- Remarks:
- Only two replicates were used instead of four as recommended.
- Qualifier:
- according to guideline
- Guideline:
- ISO 6341 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea))
- Deviations:
- yes
- Remarks:
- The pH of the dilution water was slightly higher (8.0 +/- 0.2).
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test solutions were prepared separately and mixed with test medium for a defined period. Subsequently, the test solutions were allowed to stabilize in a separating funnel. The water phase in the middle of the separating funnel was used for testing and was identified as the Water Accommodated Fraction (WAF).
- Eluate: no
- Differential loading: yes
- Controls: yes, water control
- Evidence of undissolved material: All final test solutions were clear and colourless. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: water flea
- Age at study initiation: < 24 h
- Method of breeding: Daphnia were held at a temperature of 18 – 22 °C. A new batch was started with newborn animals, i.e. less than 3 d old, by placing about 250 of them into 30 L of medium in an all-glass culture vessel. The maximum age of culture was 4 weeks. After 7 d of cultivation half of the medium was renewed. Daphnids were fed daily with a suspension of fresh water algae.
- Feeding during test: no - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Test temperature:
- 21.3 °C
- pH:
- 7.8 - 7.9
- Dissolved oxygen:
- 8.1 - 8.6 mg O2/L
- Nominal and measured concentrations:
- Nominal: 0, 86 mg/L (corresponding to 100 µL/L)
- Details on test conditions:
- TEST SYSTEM
- Test vessel: all-glass vessels
- Material, size, fill volume, headspace: all-glass, 100 mL, Fill volume: 80 mL, Headspace: 20 mL
- Aeration: no
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Medium was prepared according to ISO guideline in milli-RO water
- Culture medium different from test medium: no
OTHER TEST CONDITIONS
- Photoperiod: 16 h light / 8 h dark
EFFECT PARAMETERS MEASURED: Immobility was recorded after 24 and 48 h.
TEST CONCENTRATIONS
- Range finding study
- Test concentrations: control, WAFs at 10 and 100 mg/L (range finding study 1); control, WAFs at 0.86 and 8.6 mg/L (range finding study 2)
- Results used to determine the conditions for the definitive study: At WAFs prepared at 10 and 100 mg/L daphnids trapped at the surface of test solutions. At WAFs prepared at 0.86 and 8.6 mg/L the stabilisation period was increased to 24 h to overcome daphnids becoming trapped at the surface. No effects were observed in the second range-finding study. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Duration:
- 48 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 86 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: Water Accommodated Fraction (WAF)
- Basis for effect:
- mobility
- Details on results:
- - Mortality of control: no
- Effect concentrations exceeding solubility of substance in test medium: The test solutions at 86 mg/L (nominal) exceeded the maximum water solubility of the test substance. - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- EC50/LC50: 48 h EC50 was 0.5 mg/L (95% Confidence Limit: 0.4 - 0.6 mg/L) - Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 Jan - 01 Feb 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: WAF of 100 mg test substance/L; WAF of 100 mg test substance/L + 10 mg/L TAGAT CH 60 (emulsifier)
- Vehicle:
- yes
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A stock solution of 100 mg/L in M4-medium was prepared. It was stirred for about 24 h. After a settling time of about 2 h the solution was siphoned by a pipette and filtered via 0.2 µm membrane filter (WAF, filtered). This test solution was split up in two parts. To one of them the emulsifier TAGAT CH 60 was added at a concentration of 10 mg/L.
- Controls: A control with M4-medium and a solvent control with M4-medium and the emulsifier was conducted
- Chemical name of vehicle: TAGAT CH 60
- Concentration of vehicle in test medium: 10 mg/L - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Source: Ephippia were obtained from Creasel, 98000 Deinze, Belgium (Batch: DM / M 270999)
- Method of breeding: Ephippia were hatched in M4-medium at approx. 4800 lux and 20 °C. The incubation of neonates was performed in M4-medium according to Elendt at 20 °C and approx. 900 lux (16 h light and 8 h dark). Neonates were fed with green algae (Scenedesmus subspicatus). - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Test temperature:
- 20 °C
- pH:
- 8.0 (48 h)
- Dissolved oxygen:
- 98% (48 h)
- Nominal and measured concentrations:
- Nominal: 0, 100 mg/L
Measured (WAF of 100 mg/L): 0.2 mg/L (0 h), 0.1 mg/L (24 h), < 0.1 mg/L (48 h)
Measured (WAF, filtered + 10 mg/L TAGAT CH 60): 0.1 mg/L (0 h), < 0.1 mg/L (24 h), 0.1 mg/L (48 h) - Details on test conditions:
- TEST SYSTEM
- Test vessel: beakers
- Type: covered with glass plates
- Material, size, fill volume, headspace: glass, 100 mL, Fill volume: 50 mL, Headspace: 50 mL
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2 (WAF), 2 (WAF + emulsifier)
- No. of vessels per control (replicates): 2
- No. of vessels per vehicle control (replicates): 2
OTHER TEST CONDITIONS
- Photoperiod: 16 h light / 8 h dark
- Light intensity: approx. 900 lux
EFFECT PARAMETERS MEASURED: immobilization was noted every 24 h - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Duration:
- 48 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: Water Accommodated Fraction (WAF)
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: Water Accommodated Fraction (WAF) + Emulsifier
- Basis for effect:
- mobility
- Details on results:
- - Mortality of control: 0%
- Results with reference substance (positive control):
- - EC50 (24 h): 0.98 mg/L which is in the range of 0.9 and 1.9 mg/L proposed for validity of the test.
Referenceopen allclose all
Table 1: Immobilization of test species after 24 h and 48 h.
sample name |
replicate |
immobilised test species [%] |
|
24 h |
48 h |
||
control |
1 |
0 |
0 |
|
2 |
0 |
0 |
Solvent control |
1 |
0 |
0 |
|
2 |
0 |
0 |
WAF, filt. (100 mg/L) |
1 |
0 |
0 |
|
2 |
0 |
0 |
WAF (100 mg/L) + TAGAT |
1 |
0 |
0 |
|
2 |
0 |
0 |
Description of key information
No effects up to the limit of water solubility (< 2.5 µg/L, 20 °C; OECD 202, D. magna); read-across
Key value for chemical safety assessment
Additional information
There is no study available, in which the short-term toxicity of the target substance fatty acids, C14-22, C16-24-alkyl esters (CAS 92797-30-3) to aquatic invertebrates was assessed. Therefore, read-across to the structurally related source substances fatty acids, C16-18, C12-18-alkyl esters (CAS 95912-87-1) and 2-octyldodecyl isooctadecanoate (CAS 93803-87-3) was conducted in accordance with Regulation (EC) No. 1907/2006 Annex XI, 1.5. The source substances are characterized by fatty acid esters of similar chain lengths and are therefore considered suitable representatives for the assessment of the short-term toxicity of the target substance to aquatic invertebrates. A detailed justification of the analogue approach is provided in IUCLID section 13.
The available study with the source substance fatty acids, C16-18, C12-18-alkyl esters (CAS 95912-87-1) was conducted according to EU Method C. 2 and GLP (BASF, 2001). In a static test, the water fleaDaphnia magnawas exposed to a Water Accommodated Fraction (WAF) with a nominal loading concentration of 100 mg/L for 48 h. The test material concentrations were analytically determined by GC and were 0.1 to 0.2 mg/L or below the limit of detection.
After 48 h, no effects were observed and an EL50 (48 h) of > 100 mg/L (nominal) was derived. Thus, fatty acids, C16-18, C12-18-alkyl esters (CAS 95912-87-1) does not cause toxic effects to aquatic invertebrates up to the limit of water solubility (< 0.05 mg/L).
The available study with the source substance 2-octyldodecyl isooctadecanoate (CAS 93803-87-3) was conducted according to OECD guideline 202 and GLP (Croda, 1998). In a static limit test,D. magnawas exposed to a WAF with a nominal loading concentration of 86 mg/L. An analytical verification of the actual test material concentration in the test vessels was not possible due to the very low water solubility of the test item. After 48 h, no immobilization was observed and an EL50 (48 h) of > 86 mg/L (nominal) was derived. Thus, 2-octyldodecyl isooctadecanoate (CAS 93803-87-3) does not cause toxic effects to aquatic invertebrates up to the limit of water solubility (< 0.05 mg/L).
Based on the structural and chemical similarity of the target and source substances, the target substance is expected to exhibit a similar ecotoxicological profile as the source substances. Therefore, it can be concluded that the target substance fatty acids, C14-22, C16-24-alkyl esters (CAS 92797-30-3) does not cause short-term effects to aquatic invertebrates up to the limit of water solubility (< 2.5 µg/L).
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.
