Registration Dossier

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 Nov. 1991 - 23 Nov. 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose:
reference to other study
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: stirring for 20 h, then allowed to stand  for 4 h before testing;
- Eluate: no, suspensions were tested
- Differential loading: yes, 1000 + 10,000 mg/L
- Controls: Synthetic medium from groundwater
- Evidence of undissolved material (e.g. precipitate, surface film, etc): The resulting suspensions at the beginning of the test were homogeneous and milky, at the end of the test in addition a layer of white, starchy flocks on the bottom of the vessels was observed.



Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
- Strain:
- Source: M.B. Ruysbroek B.V./Noordvliet 159, Maassluis
- Age at study initiation (mean and range, SD):
- Length at study initiation (length definition, mean, range and SD): 2.2 +-0.2 cm
- Weight at study initiation (mean and range, SD): 0.09 +-0.02 g
- Method of breeding:
- Feeding during test: no


ACCLIMATION
- Acclimation period: no data
- Type and amount of food: no data
- Feeding frequency: no data
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
none
Hardness:
204 mg/L as CaCO3
Test temperature:
24.5 - 25.3 °C
pH:
7.3 - 8.2
Dissolved oxygen:
7.1 - 8.2 mg/L
Salinity:
not applicable
Nominal and measured concentrations:
1000 and 10,000 mg SiO2/L (nominal)
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: glass beaker, 2 L, 1000 ml test suspension
- Aeration: slight aeration (no data)
- Type of flow-through (e.g. peristaltic or proportional diluter): --
- Renewal rate of test solution (frequency/flow rate): no
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- No. of vessels per vehicle control (replicates): --
- Biomass loading rate: approx. 0.9 g fish/L


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: prepared from groundwater by addition of several salts
- Total organic carbon: 1.7 mg/L
- Alkalinity: -- no data
- Ca/Mg ratio: 1.83
- Conductivity: --



OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light, 8 h dark
- Light intensity: -- no data


EFFECT PARAMETERS MEASURED (with observation intervals if applicable): survival. swimming behaviour, colour, respiratory function,
morphological and physiological changes that were visually observable at 24, 48, 72, and 96 h


TEST CONCENTRATIONS
- Spacing factor for test concentrations: 10
- Justification for using less concentrations than requested by guideline: limit test, expected low toxicity
- Range finding study
- Test concentrations: --
- Results used to determine the conditions for the definitive study: --
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LL0
Effect conc.:
10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks:
: 0/20 animals died
Details on results:
- Behavioural abnormalities: none
- Observations on body length and weight: none
- Other biological observations: no particular findings
- Mortality of control: none
- Other adverse effects control: none
- Abnormal responses: none
Results with reference substance (positive control):
not appliicable
Reported statistics and error estimates:
not applicable
Validity criteria fulfilled:
yes
Conclusions:
Aerosil 200 was not acutely toxic to Brachydanio rerio at a loading of 10,000 mg/l.
Executive summary:

After 96 h of exposure all animals were alive and their condition (swimming behaviour, colour, respiratory function or any other visually observable morphological or behavioural criterion) was equal to that of the control animals.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Test organisms (species):
Pimephales promelas
Test type:
static
pH:
control: 7.3 (t0), 7.5 (t96h)
0.5 mg/L: 7.3 (t0), 7.6 (t96h)
1.0 mg/L: 7.3 (t0), 7.6 (t96h)
50 mg/L: 7.4 (t0), 7.6 (t96h)
500 mg/L: 7.7 (t0), 7.7 (t96h)
5000 mg/L: 8.8 (t0), 8.0(t96h)
Dissolved oxygen:
[mg/L]
control: 8.5 (t0), 8.0 (t96h)
0.5 mg/L: 8.5 (t0), 8.2 (t96h)
1.0 mg/L: 8.5 (t0), 7.8 (t96h)
50 mg/L: 8.5 (t0), 7.9 (t96h)
500 mg/L: 8.5 (t0), 8.1 (t96h)
5000 mg/L: 8.5 (t0), 7.1 (t96h)
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
other: LC20
Effect conc.:
5 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 20% mortality
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 5 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
500 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
Based on visual observation, the water control solution and the test solutions were clear with no color throughout the test. Mortalities were 0,0,0,0, 0 and 20% in the 0, 0.5, 1.0, 50, 500 and 5000 mg/L test concentratins, respectively. All water parameters were within acceptable limits.
Validity criteria fulfilled:
not applicable
Conclusions:
Colloidal silica (40% SiO2 in water) exhibited very low toxicity in a 96-hour, unaerated, static acute test using fathead minnow, Pimephales promelas
Executive summary:

A range-finding study was performed to provide an estimate of aquatic toxicity using fixed test concentrations (0, 0.5, 1.0, 50, 500, 5000 mg/L). Based on visual inspection, all test solutions were clear with no color throughout the test. Mortalities were 0, 0, 0, 0, 0 and 20% in the 0, 0.5, 1.0, 50, 500 and 5000 mg/L test concentratins, respectively. All water parameters were within acceptable limits.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
09 Dec. 1991 - 13 Dec. 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: stirring for 20 h, then allowed to stand for 4 h before testing;
- Eluate: no, suspensions were tested
- Differential loading: yes, 1000 + 10,000 mg/L
- Controls: Synthetic medium from groundwater
- Evidence of undissolved material (e.g. precipitate, surface film, etc): The test solutions remained turbid throughout the test, and starchy particles were observed on the bottom of the test vessels.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
- Strain: --
- Source: M.B. Ruysbroek B.V./Noordvliet 159, Maassluis
- Age at study initiation (mean and range, SD):
- Length at study initiation (length definition, mean, range and SD): 2.1 +-0.1 cm
- Weight at study initiation (mean and range, SD): 0.07 +-0.01 g
- Food during test: no

ACCLIMATION
- Acclimation period: no data
- Type and amount of food: no data



Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
none
Hardness:
204 mg/L as CaCO3
Test temperature:
24.2 - 25.3
pH:
7.3 - 8.3
Dissolved oxygen:
7.3 - 8.5 mg/L
Salinity:
not applicable
Nominal and measured concentrations:
1000 and 10,000 mg/L SiO2 nominal (loading)
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: glass beaker, 2 L, 1500 ml test suspension
- Aeration: slight aeration (no data)
- Type of flow-through (e.g. peristaltic or proportional diluter): --
- Renewal rate of test solution (frequency/flow rate): no
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- No. of vessels per vehicle control (replicates): --
- Biomass loading rate: approx. 0.5 g fish/L


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: prepared from groundwater by addition of several salts
- Total organic carbon: 1.7 mg/L
- Alkalinity: -- no data
- Ca/Mg ratio: 1.83
- Conductivity: --


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light, 8 h dark
- Light intensity: -- no data


EFFECT PARAMETERS MEASURED (with observation intervals if applicable): survival. swimming behaviour, colour, respiratory function,
morphologial and physiological changes that were visually observable at 24, 48, 72, and 96 h


TEST CONCENTRATIONS
- Spacing factor for test concentrations: 10
- Justification for using less concentrations than requested by guideline: limit test, expected low toxicity
- Range finding study
- Test concentrations: --
- Results used to determine the conditions for the definitive study: --
Key result
Duration:
96 h
Dose descriptor:
LL0
Effect conc.:
10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks:
: 0/20 animals died
Details on results:
- Behavioural abnormalities: none
- Observations on body length and weight: none
- Other biological observations: no particular findings
- Mortality of control: none
- Other adverse effects control: none
- Abnormal responses: none
Results with reference substance (positive control):
not applicable
Reported statistics and error estimates:
not applicable

After 96 h of exposure all animals were alive and their conditions (swimming behaviour, colour, respiratory function or any other visually observable morphological or bahavioural criterion) was equal to that of the control animals.

Validity criteria fulfilled:
yes
Conclusions:
Ultrasil VN3 was not acutely toxic to Danio rerio at loadings of 1000 and 10,000 mg/l.
Executive summary:

Test solutions were prepared by stirring an excess amount (1000 or 10,000 mg/L loading) for 20 h and the resulting suspension was tested..After 96 h of exposure all animals were alive and their conditions (swimming behaviour, colour, respiratory function and any other visually observable morphological or bahavioural criterion) was equal to that of the control animals.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1984
Deviations:
yes
Remarks:
temperature was slightly higher than recommended for the species used
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
Dilutions of the test substance at 1000 and 10,000 mg/L were stirred for 20 hours and then allowed to stand for 4 hours before addition of the test organisms.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
acclimatisation period not reported
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Test temperature:
25.4 - 25.8 °C
pH:
control group: 7.9 - 8.2, 1000mg/L: 7.9-8.2, 10000mg/L 7.9 - 8.3
Dissolved oxygen:
control group: 7.4 - 8.6mg/L, 1000mg/L: 7.6 - 8.6mg/L, 10000mg/L: 8.0 - 9.2mg/L
Nominal and measured concentrations:
1000 and 10,000mg/L (nominal)
Details on test conditions:
suspensions were tested. The test media were turbid at the beginning of the test, indicating that the limit of solubility was exceeded. Undissolved substance was present on the surfaces of the test media.
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LL0
Effect conc.:
10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat. (total fraction)
Basis for effect:
mortality
Key result
Duration:
96 h
Dose descriptor:
NOELR
Effect conc.:
10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat. (total fraction)
Basis for effect:
mortality
Details on results:
Concentrations tested were above the solubility limit, and undissolved test substance was observed on the bottom and surface of the suspension.
No mortality to zebra fish was observed up to the highest loading tested (10,000 mg/L).
Validity criteria fulfilled:
yes
Conclusions:
After 96 hours of exposure, no mortality and no sublethal effects were noted up to the highest tested loading rate of 10,000mg/L. It can be concluded that the substance has a low acute toxicity to Danio rerio
Executive summary:

Suspensions were tested. No mortality was observed for the fish after 96 hours of exposure, at loading rates of 1,000 mg/L and 10,000 mg/L. The test media were turbid at the beginning of the test, indicating that the limit of solubility was exceeded. Undissolved substance was present on the surfaces of the test media. The actual concentrations were not determined.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 March 2000 to 15 June 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes (incl. certificate)
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
Dilutions of the test substance at 100, 1000 and 10,000 mg/L were stirred for 24 hours and then filtered before addition of the test organisms.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
no
pH:
20.5 to 21.1°C
Dissolved oxygen:
8.3 to 8.9 mg O2/L
Nominal and measured concentrations:
100, 1000 and 10,000 mg/L (nominal)
Details on test conditions:
Test solutions were prepared by stirring test material for 24 hours at room temperature on a shaker (130 rpm), followed by filtration through paper filters.
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LL0
Effect conc.:
10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
mortality
Key result
Duration:
96 h
Dose descriptor:
NOELR
Effect conc.:
10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
mortality
Details on results:
No mortality to zebra fish was observed up to the highest loading tested (10,000 mg/L).
3, 3, and 7 fish were used at 100, 1000 and 10000 mg/L, respectively. Mortality was checked at 24, 48, 72 and 96 hours.
Results with reference substance (positive control):
No reference substance was used.
Executive summary:

No mortality was observed for the fish after 96 hours of exposure to the water soluble fraction at a loading rate of up to 10,000 mg/l.

The actual concentrations were not determined.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 December 1999 to 24 March 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1992
Deviations:
yes
Remarks:
modification to the standard method for the preparation of aqueous media and exposure of organisms to a filtered Water Accommodated Fraction (WAF)
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Version / remarks:
1992
Deviations:
yes
Remarks:
modification to the standard method for the preparation of aqueous media and exposure of organisms to a filtered Water Accommodated Fraction (WAF)
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: stirring with water for 143 hours, then a 1-hour settlement period to ensure saturation of the test media by any soluble components; the test material phase was then separated by filtration and the test organisms exposed to the aqueous phase (filtered water accomodated fraction; WAF). Exposures are expressed in terms of the original concentration of test material in water at the start of the mixing period (loading rate) irrespective of the actual concentration of test material in the filtered WAF.
- Loading: 1000 mg/L
- Controls: dechlorinated laboratory water
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: rainbow trout
- Source: Brow Well Fisheries, Yorkshire, United Kingdom
- Mean standard length at the end of the definitive study: 4.8 cm (sd = 0.4)
- Mean weight at the end of the definitive study: 1.57 g (sd = 0.43)
- Feed: commercial trout pellets, discontinued 24 hours prior to definite test
ACCLIMATION
- Acclimation period: 12 days
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
none
Hardness:
Approximately 100 mg/L as CaCO3
Test temperature:
Controlled at 14 °C
pH:
7.6 - 8.1
Dissolved oxygen:
9.4 - 9.8 mg/L
Salinity:
not applicable
Nominal and measured concentrations:
1000 mg/L loading; compound specific analysis in the aqueous phase or WAF could not be performed as no suitable method could be developed. Therefore samples of the WAF were taken and analysed for dissolved silicon concentration by AAS and for Dissolved Organic Carbon.
Details on test conditions:
TEST SYSTEM
- Test vessel: 20-litre vessels, covered and aerated;
- Renewal rate of test solution (frequency): daily
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- Biomass loading rate: approx. 0.79 g bodyweight/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: dechlorinated laboratory water
- Total organic carbon of dilution water: 1.1 mg/L
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light, 8 h dark with 20 minute dawn and dusk transition periods
RANGE FINDING STUDY: yes
- Test concentrations: 10, 100, 1000 mg/L (3 fish/concentration); no mortalities observed
- Results used to determine the conditions for the definitive study: yes
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LL50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
other: loading rate filtered water accommodated fraction
Basis for effect:
mortality
Remarks:
0/20
Key result
Duration:
96 h
Dose descriptor:
NOELR
Effect conc.:
1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
other: loading rate filtered water accommodated fraction
Basis for effect:
mortality
Details on results:
- Behavioural abnormalities: none
- Other biological observations: no particular findings
- Mortality of control: none
- Other adverse effects control: none
Results with reference substance (positive control):
not applicable
Reported statistics and error estimates:
not applicable
Validity criteria fulfilled:
not specified
Conclusions:
The 96-hour lethal loading rate (LL50) based on nominal loading rates was greater than 1000 mg/L (loading rate with filtered water accomodated fraction).
Executive summary:

A GLP study was performed in accordance with OECD and EC guidelines to assess the acute toxicity of the test item to rainbow trout (Oncorhynchus mykiss). Following a range-finding study fish were exposed, in two groups of ten, to a filtered water accommodated fraction (WAF) of the test item, at a single loading rate of 1000 mg/L for a period of 96 hours under semi-static test conditions. The number of mortalities and any sub-lethal effects of exposure in each test and control vessel were determined 3 and 6 hours after the start of exposure and then daily throughout the study until termination after 96 hours. There were no mortalities or abnormalities in the behaviour observed and correspondingly the No Observed Effect Loading Rate (filtered WAF) was 1000 mg/L.

Description of key information

Three GLP studies using OECD and EC guidelines are avilable for hydrophilic SAS. The acute toxicity of SAS (pyrogenic, precipitated) was determined in two studies with Brachydanio rerio. Suspensions were prepared by stirring an excessive concentration (1000 or 10,000 mg/L loading) for 20 h; the resulting suspension was tested. No effects were observed at 10,000 mg/L. The 96h NOEC in Pimephales promelas for colloidal silica was at 500 mg/L, with 20% mortality observed at 5000 mg/L.

For surface-treated SAS, three GLP studies using OECD and EC guidelines are available. None of the studies showed any toxic effects. No mortalities or abnormalities in the behaviour of fish (zebrafish and rainbow trouts) were observed. One zebrafish test was performed with hydrophobic SAS in suspension, the other test in zebrafish was performed with the filtered water-accomodated fraction; also in the test using rainbow trouts the filtered water accommodated fraction was used. The 96-hour LL0 values were 1000 mg/L (filtered Water Accommodated Fraction (WAF), nominal, highest tested loading rate; rainbow trout,) and 10,000 mg/L (suspension and filtered WAF, nominal; zebrafish).

Key value for chemical safety assessment

Additional information

LC50 value was not determined in all studies within the range of test concentrations of which the highest concentration was much greater than the concentration limit of 100 mg/l recommended in the current OECD TG 203.