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Long-term toxicity to aquatic invertebrates

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Reference
Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19th of September 2019 to 15th of January 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EPA OPPTS 850.1300 (Daphnid Chronic Toxicity Test)
Version / remarks:
1996
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Version / remarks:
2012
Deviations:
yes
Remarks:
Only one concentration used (rather than five)
GLP compliance:
yes (incl. certificate)
Remarks:
In total, three exceptions are listed, however, these are not expected to have provided any impact on the quality of the study.
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 0 (water control) and 12 mg methylsilanetriol/L
- Sampling method: The bulk water control and bulk test solution were sampled at test initiation (day 0) and on days 2, 7, 14 and 19 of the exposure. Spent (pooled replicate) solutions were sampled on days 2, 5, 7 and 14 as well as at exposure termination (day 21). To assess analytical method precision and solution homogeneity, three additional samples were collected on day 0, 7, 14 and 19 from the bulk test solution. The collected samples were analysed for methylsilanetriol by HPLC/MS-MS. Validation of the analytical methodology was conducted concurrently with the study as per standard operating procedure (SOP) MTH-ACL-2 (2014).
- Sample storage conditions before analysis: Not reported.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The definitive test was conducted under static-renewal conditions for 21 days. Ten replicate test vessels, each containing test solution or LDW were prepared per test level. At test initiation, one daphnid was impartially added to each test vessel within 30 minutes of the addition of the test solutions. The replicate test vessels were placed into a temperature-controlled environmental chamber according to a computer-generated randomization.
- Eluate: not specified
- Differential loading: not specified
- Controls: water
- Chemical name of vehicle: n/a
- Concentration of vehicle in test medium: n/a
- Evidence of undissolved material: not specified
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna
- Strain/clone: n/a
- Justification for species other than prescribed by test guideline: n/a
- Age at study initiation: Less than 24 hours
- Weight at study initiation: n/a:
- Length at study initiation: Mean length per surviving adult female were 4.81 mm in the water control and 4.85 mm in the 10.0 mg/L test level.
- Stage and instar at study initiation: n/a
- Valve height at study initiation, for shell deposition study: n/a
- Peripheral shell growth removed prior to test initiation: n/a
- Method of breeding: n/a
- Source: In house cultures obtained originally from Aquatic BioSystems, Inc., Fort Collins, Colorado
- Age of parental stock: n/a
- Feeding during test : Daphnids were fed with Raphidocelis subcapitata and YTC (yeast, wheat grass, finfish food suspension) daily from the test initiation (day 0) to day 20, however, not on day 21.
- Food type: Raphidocelis subcapitata and YTC (yeast, wheat grass, finfish food suspension)
- Amount: 0.8 mL Raphidocelis subcapitata and 0.1 mL YTC (yeast, wheat grass, finfish food suspension) daily between day 0-6. Thereafter, 0.9 ml of Raphidocelis subcapitata and 0.1 mL YTC between day 7-20. No food was provided on day 21. Therefore, the final feeding ration resulted in approximately 0.2 mg C/daphnid/day throughout the entire exposure period.
- Frequency: daily

ACCLIMATION
- Acclimation period: n/a
- Acclimation conditions: n/a
- Type and amount of food: n/a
- Feeding frequency: n/a
- Health during acclimation: not specified

QUARANTINE
- Duration: n/a
- Health/mortality: n/a

METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES, INCLUDING CULTURING CONDITIONS: n/a
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
21 d
Post exposure observation period:
n/a
Hardness:
58-62 mg CaCO3/L
Test temperature:
19–20°C
pH:
7.7-8.9
Dissolved oxygen:
8.0–10.5 mg/L (90–118% air saturation)
Salinity:
not specified
Conductivity:
160-170 µS/cm
Nominal and measured concentrations:
Nominal test concentration: 0 (water control) and 12 mg methylsilanetriol/L
Mean measured test concentrations: < LLQ (water control) and 10.0 mg methylsilanetriol/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 125-mL glass borosilicate jars containing approximately 90 mL of test solution. Each test vessel was loosely covered and uniquely labeled for identification purpose (i.e. replicate, study, test level). Test vessels were replaced with new/clean test vessels on renewal days.
- Type: closed
- Material/size/headspace/fill volume: Glass/125 ml/not specified/90 ml
- Aeration: not specified
- Type of flow-through: Septum Purge Flow (for the GC)
- Renewal rate of test solution (frequency/flow rate): 1 mL/min
- No. of organisms per vessel: 1 daphnia per vessel
- No. of vessels per concentration: 10
- No. of vessels per control: not specified
- No. of vessels per vehicle control: n/a
- Biomass loading rate: not specified

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: The water was obtained from the upper Saginaw Bay of Lake Huron off Whitestone Point and was limed and flocculated with ferric chloride. Before use in the laboratory, the water was sand-filtered, pH-adjusted with gaseous CO2, carbon-filtered, and UV-irradiated.
- Total organic carbon: 1.9 mg/L,
- Particulate matter: < 2 mg/L
- Metals/pesticides/chlorine/alkalinity/Ca/mg ratio: concentrations of contaminants were below levels of concern that may have interfered with the results of this test.
- Conductivity: 160-170 μS/cm
- Culture medium different from test medium: No
- Intervals of water quality measurement: Weekly

OTHER TEST CONDITIONS
- Adjustment of pH: Yes, with gaseous CO2
- Photoperiod: 16 hours light/8 hours dark per day
- Light intensity: Not exceeding 1000-1500 lux.

EFFECT PARAMETERS MEASURED: not specified

TEST CONCENTRATIONS
- Spacing factor for test concentrations: not specified
- Justification for using less concentrations than requested by guideline: not specified
- Range finding study: No, based on available literature
- Test concentrations: 12 mg methylsilanetriol/L
- Results used to determine the conditions for the definitive study:
Reference substance (positive control):
no
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
10 mg/L
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
LOEC
Remarks:
MATC
Effect conc.:
> 10 mg/L
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
10 mg/L
Conc. based on:
test mat.
Basis for effect:
growth
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
> 10 mg/L
Conc. based on:
test mat.
Basis for effect:
growth
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
10 mg/L
Conc. based on:
test mat.
Basis for effect:
other: mortality: Number of living offspring produced per surviving parental animal {for Daphnia magna, TG 211} (migrated information)
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
> 10 mg/L
Conc. based on:
test mat.
Basis for effect:
other: mortality: Number of living offspring produced per surviving parental animal {for Daphnia magna, TG 211} (migrated information)
Details on results:
- Behavioural abnormalities: No
- Observations on body length and weight: The daphnid lengths in the water control were not statistically different to the mean length per surviving adult female. No weight is recorded.
- Other biological observations: All biological data were normally distributed and homogenous.
- Mortality of control: 0 %
- Other adverse effects control: None reported
- Immobilisation of control: None reported
- Abnormal responses: None reported
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No
- Effect concentrations exceeding solubility of substance in test medium: No
Results with reference substance (positive control):
- Results with reference substance valid? Yes
- Relevant effect levels: Yes
Reported statistics and error estimates:
Shapiro-Wilk’s test at a Type I error rate of 0.01 was utilised for the testing of normality for reproduction and growth (length). To evaluate the homogeneity of variance, Levene's test at a type I error rate of 0.05 was used. Furthermore, a parametric analysis (ANOVA) was conducted using a Dunnett's test to compare the limit test level with the water control. one-tailed Dunnett’s test, looking for a significant decrease from the water control, was conducted at a Type I error rate of 0.05. Additionally, the standard deviation, coeffcient of variance and mean was calculated for e.g. the individual observations
Validity criteria fulfilled:
yes
Conclusions:
A 21 day NOEC value of 10 mg/l (mean measured concentration) (highest concentration tested) has been determined for the effects of methylsilanetriol on reproduction, growth (length) and mortality of Daphnia magna. Additionally,a LOEC for the same endpoints was determined to be >10 mg/L.
Executive summary:

A 21 day chronic toxicity study in Daphnia magna with the test substance methylsilanetriol (pre-hydrolysed from the parent substance methyltrimethoxysilane) was conducted according to OECD TG 211 and in compliance with GLP. A 21 day NOEC value of 10 mg/l (mean measured concentration) (highest concentration tested) was determined for the effects of methysilanetriol on reproduction, growth (length) and mortality. Additionally, a LOEC for the same endpoints was determined to be >10 mg/L.

Description of key information

Long-term toxicity to invertebrates: 21 day NOEC 10 mg/l (highest concentration tested) (OECD 211), for the effects of the hydrolysis product methylsilanetriol on survival and reproduction of Daphnia magna.

Key value for chemical safety assessment

Additional information

There are no reliable long-term invertebrate toxicity data available for 2,4,6,8,10-pentamethylcyclopentasiloxane (HD5, CAS 6166-86-5). Due to the rapid hydrolysis of the registered substance, the relevant species for chemical safely assessment is the hydrolysis product methylsilanetriol. Chronic Daphnia toxicity data with methylsilanetriol have been read across.

No adverse effects on Daphnia magna were observed during the test. A 21-d NOEC value of 10 mg/l (measured concentration, highest concentration tested) was determined for the effects of methylsilanetriol on survival, growth and reproduction of Daphnia magna.

Refer to Section 6 endpoint summary (Section 7.0 of CSR) for further discussion of the approach to chemical safety assessment for this registration substance, and the ecotoxicological RAAF document attached in Section 13 of IUCLID forjustification for read-across used.