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Short-term toxicity to aquatic invertebrates

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Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Study period:
July 10, 1992 - October 30, 1992
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP study performed according to OECD 202 (1984) and EC method C.2, with the single deviation of no analytical measurements. Effect concentrations exceeded solubility of substance in test medium. All test solutions were inhomogeneous milky-turbid fluids with an oily layer at the surface, and, at 32.4 mg/l and above, very small white particles at the side of the test vessels and at the surface. The observed effects are probably due to physical effects.
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
Also performed according to EEC method C.2.
Deviations:
yes
Remarks:
No analytical confirmation of concentrations of test compound in test solutions.
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 0.5 g of test substance and approximately 50 mL of water were mixed, ultrasonically treated for 10 minutes and stirred for about 15 minutes at approximately 70°C. Thereafter, deionized water was added up to a final volume of 500 mL. The stock was milky-turbid and freshly prepared before the test.
- Eluate: not relevant
- Differential loading: not relevant
- Controls: controls were untreated
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): not relevant
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)):not relevant
- Evidence of undissolved material (e.g. precipitate, surface film, etc): The stock was milky-turbid. The following was reported on the appearance of the test solutions during the test: The higher the test concentration was, the more turbid the test solutions were. 10 mg/L was slightly opaque, and 105 mg/L was milky turbid. At all test concentrations an oily layer was observed. After 24 hours, at 32.4, 58.3 and 105 mg/L very small white particles were observed at the side of the test vessels and the surface of the test fluids. The same particles were also observed at 10 and 18 mg/L after 48 hours.”
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna
- Strain: no data
- Source: from a continuous culture maintained at the testing laboratory.
- Age at study initiation (mean and range, SD): <24 h old
- Weight at study initiation (mean and range, SD): no data
- Length at study initiation (length definition, mean, range and SD): no data
- Valve height at study initiation, for shell deposition study (mean and range, SD): no data
- Peripheral shell growth removed prior to test initiation: no data
- Method of breeding: no data
- Feeding during test: unfed
- Food type: not relevant
- Amount: not relevant
- Frequency: not relevant

ACCLIMATION
- Acclimation period: not relevant (no data for brood culture)
- Acclimation conditions (same as test or not): not relevant (no data for brood culture)
- Type and amount of food: not relevant (no data for brood culture)
- Feeding frequency: not relevant (no data for brood culture)
- Health during acclimation (any mortality observed): not relevant (no data for brood culture)

QUARANTINE (wild caught)
- Duration: not relevant
- Health/mortality: not relevant
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Post exposure observation period:
Not relevant
Hardness:
Not measured during study.
Test temperature:
Overall range during the test 19.9-19.5°C
pH:
Overall range during the test 7.8-8.1
Dissolved oxygen:
Overall range during the test ≥8.1 mg/L (≥89% of saturation)
Salinity:
Not relevant
Nominal and measured concentrations:
Nominal concentrations were 0, 10, 18, 32.4, 58.3 and 105 mg/L.
The nominal concentrations were not verified by chemical analysis.
Details on test conditions:
TEST SYSTEM
- Test vessel: glass beaker
- Type (delete if not applicable): covered with glass plate
- Material, size, headspace, fill volume: 400 mL glass beaker, fill volume 250 mL
- Aeration: no
- Type of flow-through (e.g. peristaltic or proportional diluter): not relevant
- Renewal rate of test solution (frequency/flow rate): not relevant (static test)
- No. of organisms per vessel: five
- No. of vessels per concentration (replicates): four
- No. of vessels per control (replicates): four
- No. of vessels per vehicle control (replicates): not relevant
- Biomass loading rate: no data

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: The dilution water was a synthetic water, Dutch standard water of pH 8.2 and 12° dH, containing per litre of deionised water: 100 mg NaHCO3, 20 mg KHCO3, 200 mg CaCl2•2H2O, 180 mg MgSO4•7H2O.
- Total organic carbon: the deionised water had TOC <2 mg/L
- Particulate matter: no data
- Metals: the deionised water had ≤0.01 mg/L copper
- Pesticides: no data
- Chlorine: no data
- Alkalinity: no data
- Ca/mg ratio: not reported
- Conductivity: the deionised water had conductivity <5 µS/cm
- Culture medium different from test medium: no data
- Intervals of water quality measurement: pH and oxygen were measured at 0 and 48 hours, temperature was recorded continuously.

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours of ambient light per day, supplied by fluorescent tubes
- Light intensity: no data

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): immobility at 24 and 48 hours.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8
- Justification for using less concentrations than requested by guideline: not relevant
- Range finding study: yes
- Test concentrations: 0, 1, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: At 0, 1, 10 and 100 mg/L, respectively, immobility was 0%, 0%, 0% and 100%.

Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 32.4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: Based on inhomogeneous turbid test solutions, no chemical analysis of test substance concentrations.
Details on results:
- Behavioural abnormalities: yes: animals trapped at the surface were observed in all treated test solutions (but not in the control); At 32.4, 58.3 and 105 mg/L, the following findings were observed: old carapaces still attached to the daphnids, some daphnids attached to each other, some lying at the bottom of the test vessel.
- Observations on body length and weight: no data
- Other biological observations: no data
- Mortality of control: 0%
- Other adverse effects control: none
- Abnormal responses: no data
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: The higher the test concentration was, the more turbid the test solutions were. 10 mg/L was slightly opaque, and 105 mg/L was milky turbid. At all test concentrations an oily layer was observed. After 24 hours, at 32.4, 58.3 and 105 mg/L very small white particles were observed at the side of the test vessels and the surface of the test fluids. The same particles were also observed at 10 and 18 mg/L after 48 hours.
- Effect concentrations exceeding solubility of substance in test medium: yes (see below)
Results with reference substance (positive control):
No data
Reported statistics and error estimates:
The following was reported: "If all animals survive in a limit test, there is according to the binomial theory a 99% confidence that the EC50 (48h) is higher that that concentration the limit test is performed with. According to the binomial theory, the EC50 is higher than 32.4 mg/L with a 99% confidence." This approach is considered to be acceptable.

The reported EC50 was >32.4 mg/L. All test solutions were inhomogeneous milky-turbid fluids with an oily layer at the surface, and, at 32.4 mg/l and above, very small white particles at the side of the test vessels and at the surface. The actual concentrations were not confirmed by chemical analysis. All tested concentrations were far above the solubility limit of the test material in water, which is <1 mg/L. The solubility limit in reconstituted test medium may be even less than that in water. Due to the fact that the test solutions were inhomogeneous milky-turbid fluids with an oily layer at the surface, far in excess of the solubility limit, the concentrations of which were not analytically determined, there is no information about the actual concentrations to which the test organisms were exposed during the study. The method of preparation of the test solutions involved the preparation of a stock (nominal concentration 1000 mg/L) by ultrasonic treatment for 10 minutes and stirring for 15 minutes at 70°C, followed by addition of deionized water. No measures were taken to enhance the dissolving and dispersion of the test material after the addition of deionized water. Furthermore, the test solutions were prepared by adding an aliquot of the stock solution to synthetic test medium, and no measures were taken to enhance the dissolving and dispersion of the test material after this step. It is therefore not certain that the solubility limit of the test substance in the test solutions was achieved. Therefore it is not considered to be justified to state that the EC50 is in excess of the solubility limit in water. The conclusion from this study should be that the EC50 is >32.4 mg/L, determined with inhomogeneous test solutions, the concentrations of which were not confirmed by chemical analysis. The immobility at the high test concentrations was probably due to physical effects.

Validity criteria fulfilled:
no
Remarks:
Inhomogeneous test solutions, concentrations not confirmed by chemical analysis.
Conclusions:
Study according to OECD 202 (1984): static test, EC50 >32.4 mg/L, determined with inhomogeneous test solutions, concentrations not confirmed by chemical analysis, immobility probably due to physical effects.
Executive summary:

Study according to OECD 202 (1984): static test, EC50 >32.4 mg/L, determined with inhomogeneous test solutions, concentrations not confirmed by chemical analysis. Effect concentrations exceeded solubility of substance in test medium. All test solutions were inhomogeneous milky-turbid fluids with an oily layer at the surface, and, at 32.4 mg/l and above, very small white particles at the side of the test vessels and at the surface. The observed effects are probably due to physical effects.

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 March 2010 to 12 March 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
Qualifier:
according to guideline
Guideline:
ISO 6341 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea))
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Guidance document on aquatic toxicity testing of difficult sunstances and mixtures, OECD series on testing and assesment number 23, December 14, 2000.
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
During the test singular samples for TOC-analysis were taken from the WAF prepared at a loading rate of 100 mg/l and the untreated control according to the schedule below.

Frequency at t=0 h and t=48 h
Volume 40 ml
Storage Samples were stored in a refrigerator until analysis.
Vehicle:
no
Details on test solutions:
The batch of Blown rapeseed oil tested was a yellow/brown viscous liquid with a purity indicated as 100% and not completely soluble in test medium at the concentrations tested.

Preparation of the test solutions started with loading rates prepared individually at 1.0, 10 and 100 mg/l applying 48 hours of magnetic stirring to achieve maximum dissolution in test medium. The magnetic stirring was followed by a settlement period of 2 hours. This resulted in clear and colourless to slightly hazy solutions with a floating layer. The Water Accommodated Fractions (WAFs) were then collected by siphoning the water phase. The WAFs of 1.0 and 10 mg/l were all clear and colourless, while the WAF prepared at 100 mg/l was slightly hazy.
Test organisms (species):
Daphnia magna
Details on test organisms:
- Common name: Daphnia magna (Crustacea, Cladocera) (Straus, 1820)
- Source: In-house laboratory culture with a known history.
- Age at study initiation: < 24 hours
- Method of breeding: With newborn daphnids, i.e. less than 3 days old, by placing about 250 of them into 10 litres of medium in an all-glass culture vessel.
- Feeding during test: No
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
180 mg/l expressed as CaCO3
Test temperature:
between 19.6 and 20.4°C
pH:
7.9
Dissolved oxygen:
between 9.0 and 9.5
Nominal and measured concentrations:
Nominal concentrations: control and 100 mg/L
Measured concentrations: Analyses were based on Total Organic Carbon (TOC) contents. The TOC concentrations measured in the treated samples were only slightly exceeding those measured in the control samples, indicating that the actual test substance concentration was very low. The actual measured concentration was at approximately 1.0 to 1.5 mg C/l when corrected for the carbon measured in the control samples. The TOC content of Blown rapeseed oil was determined to be 74.01% (based on NOTOX Project 493030). Thus, the actual Blown rapeseed oil concentration in solution was between approximately 1.4 and 2.0 mg/l.
The low exposure concentration was not unexpected considering the poor solubility of Blown rapeseed oil and the observed undissolved test substance that was present as a floating layer in the dispersion after stirring and which was removed when collecting the water phase for testing.

Details on test conditions:
- Type: open
- Material, size, headspace, fill volume: glass, 100 ml, normal headspace, 80 ml
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4 for the highest concentration and 2 for the lower concentrations
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Adjusted ISO medium: the following chemicals (analytical grade) are dissolved in tap water purified by Reverse Osmosis (RO-water, GEON Waterbehandeling, Berkel-Enschot, The Netherlands):
Macro salts:
CaCl2.2H2O : 211.5 mg/l
MgSO4.7H2O: 88.8 mg/l
NaHCO3 : 46.7 mg/l
KCl : 4.2 mg/l
The hardness: 180 mg/l expressed as CaCO3 and the pH: 7.7 ± 0.3 after aeration.
- Culture medium different from test medium: yes, for culturing M7 medium is used
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours photoperiod daily
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : EC50 t=24, 48 h and NOEC
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 10
- Test concentrations: control and 1.0, 10, 100 mg/l
Reference substance (positive control):
yes
Remarks:
potassium dichromate (K2Cr2O7,)
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
100 other: mg/l (WAF prepared at a loading rate of 100 mg/l)
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 other: mg/l (WAF prepared at a loading rate of 100 mg/l)
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 100 other: mg/l (WAF preared at a loading rate of 100 mg/l)
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
Behavioural abnormalities: no
- Immobility of control: no immobility was observed.
- Other adverse effects control: no
Results with reference substance (positive control):
The 24h-EC50 was 0.75 mg/l with a 95% confidence interval between 0.56 and 1.0 mg/l.
The 48h-EC50 was 0.36 mg/l with a 95% confidence interval between 0.28 and 0.49 mg/l.
Reported statistics and error estimates:
No EC50 could be calculated because the test substance proved to be non-toxic (EC50 > maximum soluble concentration).
Validity criteria fulfilled:
yes
Conclusions:
Under the conditions of the present study Blown rapeseed oil did not induce significant acute immobilisation of Daphnia magna when exposed to a WAF prepared at a loading rate of 100 mg/l after 48 hours of exposure (NOEC). The 48h-EC50 exceeded a WAF prepared at a loading rate of 100 mg/l, which can be considered to represent the maximum soluble concentration in test medium. TOC-analyses showed that the actual concentration in solution was between approximately 1.4 and 2.0 mg/l.
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29/10/2012 - 30/10/2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according to international guideline (OECD guideline 202) under GLP.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
Principles of method if other than guideline:
Not relevant
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
Not relevant
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 100 mg/L
- Sampling method: Water samples were taken from the control and the 100 mg/L loading rate WAF test group (replicates R1 - R4 pooled) at 0 and 48 hours
- Sample storage conditions before analysis: Samples were stored at approximately -20 °C prior to analysis.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: An amount (200 mg) was added to the surface of 2 liters of reconstituted water to give the
100 mg/L loading rate. After the addition of the test item, the reconstituted 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. Microscopic observations made on the WAF indicated that a significant amount of dispersed test item was present in the water column and hence it was considered justifiable to remove the WAF by filtering through a glass wool plug (2-4 cm in length). A wide bore glass tube, covered at one end with Nescofilm was submerged into the vessel, sealed end down, to a depth of approximately 5 cm from the bottom of the vessel. A length of Tygon tubing was inserted into the glass tube and pushed through the Nescofilm seal. A glass wool plug was inserted into the opposite end of the tubing and the WAF removed by mid-depth siphoning (the first approximate 75-100 mL discarded) to give the 100 mg/L loading rate WAF. Microscopic observations of the WAF were performed after filtering and showed no microscopic particles of test item.
- Controls: yes, blanks
- Observations on solubility: At the start of the mixing period the 100 mg/L loading rate was observed to be a clear colorless water column with oily globules of test item on the surface. After 23 hours stirring and a 1-Hour standing period the 100 mg/L loading rate was observed to remain a clear colorless water column with oily globules of test item on the surface. Microscopic examination of the WAF showed microscopic particles and therefore it was considered justifiable to remove the WAF by filtering through a glass wool plug (2-4 cm in length). Microscopic examination after filtering showed the glass wool plug had removed all undissolved microscopic particles. During the test the
100 mg/L loading rate was observed to be a clear, colorless solution.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna
- Source: in-house laboratory culture
- Method of breeding: Adult Daphnia were maintained in 150 mL glass beakers containing Elendt M7 medium in a temperature controlled room at approximately 20 °C. The lighting cycle was controlled to give a 16 hours light and 8 hours darkness cycle with 20 minute dawn and dusk transition periods. Each culture was fed daily with a mixture of algal suspension (Desmodesmus subspicatus) and Tetramin® flake food suspension. Culture conditions ensured that reproduction was by parthenogenesis. 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. The diet and diluent water are considered not to contain any contaminant that would affect the integrity or outcome of the study.
- Feeding during test: no
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Post exposure observation period:
Not relevant
Hardness:
250 mg/L as CaCO3
Test temperature:
20 - 21ºC
pH:
7.3 - 8.0
Dissolved oxygen:
8.8 - 9.2 mg/L ( 98 - 101% of ASV)
Salinity:
Not relevant
Nominal and measured concentrations:
Nominal: 100 mg/l
Measured (TOC):
Details on test conditions:
TEST SYSTEM
- Test vessel: jar
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: glass, 250 mL filled with 200 mL test medium
- Aeration: None
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted wtaer
- Culture medium different from test medium: No, Elendt M7 medium
- Intervals of water quality measurement: pH, temperature and oxygen concentration were measured every 24 h, starting at 0 h

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: Test was performed in the dark, to avoid exposure of the test substance to light

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mobility (every 24h)

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: yes
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Duration:
48 h
Dose descriptor:
NOELR
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
NOELR
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Mortality of control: 0%
- Effect concentrations exceeding solubility of substance in test medium: At the start of the mixing period the 100 mg/L loading rate was observed to be a clear colorless water column with oily globules of test item on the surface. After 23 hours stirring and a 1-Hour standing period the 100 mg/L loading rate was observed to remain a clear colorless water column with oily globules of test item on the surface. Microscopic examination of the WAF showed microscopic particles and therefore it was considered justifiable to remove the WAF by filtering through a glass wool plug (2-4 cm in length). Microscopic examination after filtering showed the glass wool plug had removed all undissolved microscopic particles. During the test the
100 mg/L loading rate was observed to be a clear, colorless solution.
Results with reference substance (positive control):
- Results with reference substance valid? Yes
- EC50/LC50: 48h-EC50: 0.45 mg/L
Reported statistics and error estimates:
An estimate of the EL*50 values was given by inspection of the immobilization data.

For detailed results, see attached file "Results.docx".

Validity criteria fulfilled:
yes
Remarks:
Mortality in controls <10%, physico-chemical parameters within acceptable limits
Conclusions:
The acute toxicity (48h-EL50) of castor oil, oxidized is > 100 mg/l.
Executive summary:

The acute toxicity of castor oil, ozidized was investigated according to OECD guideline 202 under GLP. Daphnids were exposed to a WAF of 100 mg/l and observed for 48 hours. The 48h-NOEL and 48h-EL50 were found to be 100 and > 100 mg/l respectively.

Description of key information

48h-EL50: > 100 mg/l based on read-across from castor oil oxidized and rape oil, oxidized

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
100 mg/L

Additional information

Three studies are available for the acute toxicity towards Daphnia. The study with linseed oil, oxidized showed a EC50>32.4 mg/L. However, this study is disregarded because all test solutions were inhomogeneous milky-turbid fluids with an oily layer at the surface, and, at 32.4 mg/l and above, very small white particles at the side of the test vessels and at the surface. It can thus not be excluded that the observed effects are related due to physical effects.

Studies with Castor oil oxidized and Rape oil, oxidized were conducted according to OECD guideline 202 under GLP. In both studies, the 48h-NOEL and 48h-EL50 were found to be 100 and > 100 mg/l respectively. These results are read-across to Linseed oil, oxidized. The justification is provided in the read-across document.