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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 285-203-4 | CAS number: 85049-34-9
- 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
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 Aug - 06 Oct 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- GLP-Guideline study with acceptable restrictions (Oily drops of the test substance were observed on the surface of test solutions).
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: filtered stock solution of 1000 mg/L
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: 1000 mg test substance was added to 1 L drinking water, stirred for approx. 18 h and filtered. Stock solution was prepared daily.
- Eluate: No
- Differential loading: No
- Controls: yes, water control
- Evidence of undissolved material: After 72 and 96 h oily drops were observed on top of the test solution in the test vessels. - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: zebra fish
- Source: West Aquarium, Bad Lauterbach, Germany
- Length at study initiation (length definition, mean, range and SD): 3 cm ± 0.5 cm
- Feeding during test: none
ACCLIMATION
- Type and amount of food: Tetramin in an amount of approx. 1% of the body weight
- Feeding frequency: daily
- Health during acclimation (any mortality observed): Fish were healthy without any behavioural abnormalities. The mortality was <= 5% 7 d prior to test initiation.
- Other: Fish were treated with malachite green three times a week with a 14-day quarantine. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- approx. 12 °dH
- Test temperature:
- 19 - 20 °C
- pH:
- 7.8 - 8.5
- Dissolved oxygen:
- 86 - 108%
- Nominal and measured concentrations:
- nominal: control, 1000 mg/L
measured: 4.1 mg/L (0 h), 4.7 mg/L (24 h), 68 mg/L (48 h), 81 mg/L (72 h) - Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: glass aquaria, 20 L, headspace: 10 L, fill volume: 10 L
- Aeration: continuous aeration
- Renewal rate of test solution: every day
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: drinking water from the Gelsenwasser AG
OTHER TEST CONDITIONS
- Photoperiod: 16 h light / 8 h dark
EFFECT PARAMETERS MEASURED: mortality was observed every day - Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- LL0
- Effect conc.:
- >= 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LL0
- Effect conc.:
- >= 39 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- mortality (fish)
- Details on results:
- - Mortality of control: 0%
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: Oily drops on the water surface after 72 h and 96 h of exposure. - Sublethal observations / clinical signs:
The effect concentration is based on the nominal concentration because great differences were found in the measured concentrations (Table 1). Oily drops were observed after 72 and 96 h indicating an oversaturated solution. Stability testing of the test substance resulted in a deviation of < 20% from the concentration at the beginning. The test substance was biologically available.
Table 1: Measured concentrations in filtered stock solution (TOC analysis)
Concentration [mg/L]
Mean [mg/L]
0 h
24 h
72 h
96 h
Filtered stock solution
4.1
4.7
68*
81*
39
*) oversaturated solution, oily drops on the surface of test solutions
- Validity criteria fulfilled:
- yes
- Conclusions:
- After 96 h the LL0 was determined to ne > 1000 mg/L (nominal concentraion) and > 39 mg/L (measured concentration)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 Aug - 10 Oct 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- GLP guideline with acceptable restrictions (Temperature and fish length not in line with recommendations in guideline; no analytical purity of the test substance).
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- yes
- Remarks:
- Temperature ranged from 24.5 – 27.0 °C (mean 25.3 °C). Not all fish were in the range of 2.0 ± 1.0 cm.
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Deviations:
- yes
- Remarks:
- Temperature ranged from 24.5 – 27.0 °C (mean 25.3 °C).
- GLP compliance:
- yes
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: At 0 h 1.25 g of the test substance was weighed and dispersed in 5 L of hot (approx. 60 °C) carbon filtered tap water by high shear mixing at 15000 rpm for 15 min in a 5 L conical flask resulting in a 250 mg/L stock solution. Stock solution was prepared daily.
- Eluate: No
- Differential loading: No
- Controls: Yes, water control - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: zebra fish
- Source: In-house culture (from batch 48Z spawned on 15 May 1997)
- Length at study termination (mean from control tank): 3.1 cm
- Weight at study termination (mean from control tank): 0.23 g
- Method of breeding: Reared in carbon-filtered tap water and maintained under the following conditions: pH 6.5 – 8.0, temperature 25 ± 2 °C, dissolved oxygen > 60% saturated (> 4.8 mg/L) and photoperiod 16 h light and 8 h dark.
- Feeding during test: No
ACCLIMATION
- Acclimation period: 72 h (fish were starved 24 h prior to the start of the test)
- Acclimation conditions (same as test or not): Same as test conditions.
- Type and amount of food: Live and proprietary fish food (Artemia and Tetramin)
- Health during acclimation (any mortality observed): No significant mortalities in the week prior to the test. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Hardness:
- 109 - 117 mg CaCO3/L
- Test temperature:
- 24.5 - 27.0 °C
- pH:
- 7.2 - 8.1
- Dissolved oxygen:
- 5.3 - 8.0 mg O2/L
- Nominal and measured concentrations:
- nominal: 0, 10, 18, 32, 56, 100 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: all-glass tanks, 6 L, headspace: 1 L, fill volume: 5 L
- Aeration: yes
- Renewal rate of test solution (frequency/flow rate): every 24 h
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline OECD 203
OTHER TEST CONDITIONS
- Photoperiod: 16 h light / 8 h dark
- Light intensity: not measured
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mortality and other abnormalities in swimming activity and loss of balance were observed daily.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.7 - Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Behavioural abnormalities: not observed
- Validity criteria fulfilled:
- yes
- Conclusions:
- After 96 hours the LC50 was determined to be > 100 mg/L and the NOEC was determined to be 100 mg/L.
- Endpoint:
- short-term toxicity to fish
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 28 Aug - 06 Oct 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- GLP-Guideline study with acceptable restrictions (Oily drops of the test substance were observed on the surface of test solutions).
- Justification for type of information:
- Please refer section 13 for read across justification.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: filtered stock solution of 1000 mg/L
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: 1000 mg test substance was added to 1 L drinking water, stirred for approx. 18 h and filtered. Stock solution was prepared daily.
- Eluate: No
- Differential loading: No
- Controls: yes, water control
- Evidence of undissolved material: After 72 and 96 h oily drops were observed on top of the test solution in the test vessels. - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: zebra fish
- Source: West Aquarium, Bad Lauterbach, Germany
- Length at study initiation (length definition, mean, range and SD): 3 cm ± 0.5 cm
- Feeding during test: none
ACCLIMATION
- Type and amount of food: Tetramin in an amount of approx. 1% of the body weight
- Feeding frequency: daily
- Health during acclimation (any mortality observed): Fish were healthy without any behavioural abnormalities. The mortality was <= 5% 7 d prior to test initiation.
- Other: Fish were treated with malachite green three times a week with a 14-day quarantine. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- approx. 12 °dH
- Test temperature:
- 19 - 20 °C
- pH:
- 7.8 - 8.5
- Dissolved oxygen:
- 86 - 108%
- Nominal and measured concentrations:
- nominal: control, 1000 mg/L
measured: 4.1 mg/L (0 h), 4.7 mg/L (24 h), 68 mg/L (48 h), 81 mg/L (72 h) - Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: glass aquaria, 20 L, headspace: 10 L, fill volume: 10 L
- Aeration: continuous aeration
- Renewal rate of test solution: every day
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: drinking water from the Gelsenwasser AG
OTHER TEST CONDITIONS
- Photoperiod: 16 h light / 8 h dark
EFFECT PARAMETERS MEASURED: mortality was observed every day - Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- LL0
- Effect conc.:
- >= 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LL0
- Effect conc.:
- >= 39 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- mortality (fish)
- Details on results:
- - Mortality of control: 0%
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: Oily drops on the water surface after 72 h and 96 h of exposure. - Sublethal observations / clinical signs:
The effect concentration is based on the nominal concentration because great differences were found in the measured concentrations (Table 1). Oily drops were observed after 72 and 96 h indicating an oversaturated solution. Stability testing of the test substance resulted in a deviation of < 20% from the concentration at the beginning. The test substance was biologically available.
Table 1: Measured concentrations in filtered stock solution (TOC analysis)
Concentration [mg/L]
Mean [mg/L]
0 h
24 h
72 h
96 h
Filtered stock solution
4.1
4.7
68*
81*
39
*) oversaturated solution, oily drops on the surface of test solutions
- Validity criteria fulfilled:
- yes
- Conclusions:
- After 96 h the LL0 was determined to ne > 1000 mg/L (nominal concentraion) and > 39 mg/L (measured concentration)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 18 Aug - 10 Oct 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- GLP guideline with acceptable restrictions (Temperature and fish length not in line with recommendations in guideline; no analytical purity of the test substance).
- Justification for type of information:
- Please refer section 13 for read across justification.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- yes
- Remarks:
- Temperature ranged from 24.5 – 27.0 °C (mean 25.3 °C). Not all fish were in the range of 2.0 ± 1.0 cm.
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Deviations:
- yes
- Remarks:
- Temperature ranged from 24.5 – 27.0 °C (mean 25.3 °C).
- GLP compliance:
- yes
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: At 0 h 1.25 g of the test substance was weighed and dispersed in 5 L of hot (approx. 60 °C) carbon filtered tap water by high shear mixing at 15000 rpm for 15 min in a 5 L conical flask resulting in a 250 mg/L stock solution. Stock solution was prepared daily.
- Eluate: No
- Differential loading: No
- Controls: Yes, water control - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: zebra fish
- Source: In-house culture (from batch 48Z spawned on 15 May 1997)
- Length at study termination (mean from control tank): 3.1 cm
- Weight at study termination (mean from control tank): 0.23 g
- Method of breeding: Reared in carbon-filtered tap water and maintained under the following conditions: pH 6.5 – 8.0, temperature 25 ± 2 °C, dissolved oxygen > 60% saturated (> 4.8 mg/L) and photoperiod 16 h light and 8 h dark.
- Feeding during test: No
ACCLIMATION
- Acclimation period: 72 h (fish were starved 24 h prior to the start of the test)
- Acclimation conditions (same as test or not): Same as test conditions.
- Type and amount of food: Live and proprietary fish food (Artemia and Tetramin)
- Health during acclimation (any mortality observed): No significant mortalities in the week prior to the test. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Hardness:
- 109 - 117 mg CaCO3/L
- Test temperature:
- 24.5 - 27.0 °C
- pH:
- 7.2 - 8.1
- Dissolved oxygen:
- 5.3 - 8.0 mg O2/L
- Nominal and measured concentrations:
- nominal: 0, 10, 18, 32, 56, 100 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: all-glass tanks, 6 L, headspace: 1 L, fill volume: 5 L
- Aeration: yes
- Renewal rate of test solution (frequency/flow rate): every 24 h
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline OECD 203
OTHER TEST CONDITIONS
- Photoperiod: 16 h light / 8 h dark
- Light intensity: not measured
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mortality and other abnormalities in swimming activity and loss of balance were observed daily.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.7 - Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Behavioural abnormalities: not observed
- Validity criteria fulfilled:
- yes
- Conclusions:
- After 96 hours the LC50 was determined to be > 100 mg/L and the NOEC was determined to be 100 mg/L.
Referenceopen allclose all
Description of key information
No toxic effects to fish up to the limit of water solubility.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Dose descriptor:
- EC50
- Effect concentration:
- > 100 mg/L
Additional information
Since no studies investigating the short-term toxicity to fish of the test substance are available, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read across was conducted to the two structurally related substances decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7) and propylene glycol diisostearate (CAS 68958-54-3). This read-across is justified in detail in the overall summary (IUCLID chapter 6.1) and within the analogue justification in IUCLID Section 13.
The study with the read-across substance decanoic acid, mixed diesters with octanoic acid and propylene glycol was performed as a limit test according to the EU Method C.1 (GLP) with the zebrafish Brachydanio rerio under semi-static conditions (Scholz, 1995). A Water Accommodated Fraction (WAF) of 1000 mg/L did not result in any effects although oily drops were visible after 72 and 96 h. The analytical determination of the test substance based on TOC-analysis resulted in very different values since they were oversaturated, whereas the effect concentration was based on the nominal values. Thus, a LL50 of > 1000 mg/L was determined.
The second study with the read-across substance propylene glycol diisostearate was performed according to OECD 203 under GLP conditions with the zebrafish Danio rerio (van Egmond, 1997). Five concentrations up to 100 mg/L were tested in a semi-static exposure regime. No effects were observed after an exposure of 96 h resulting in a LC50 > 100 mg/L. Based on the results from structurally related read-across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile, it can be concluded that Propyleneglycol dioleate (CAS 105-62-4) will not exhibit acute effects to fish up to the limit of water solubility.
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.