Santicizer P1400

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014-04-21 to 2014-04-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Ferro Corporation; Batch no. 644878
- Expiration date of the lot/batch: Not specified
- Purity test date: 2014-01-17

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature

FORM AS APPLIED IN THE TEST (if different from that of starting material): clear, yellowish liquid

Analytical monitoring:

yes

Details on sampling:

- Concentrations:
Range Finding Test - 0 (vehicle control), 0.00010, 0.0010, 0.010, 0.10 and 1.0 µg/L
Definitive Limit Test - 0 (control), 0 (vehicle control), and 800 µg/L
- Sample storage conditions before analysis: samples were stored at room temperature

Vehicle:

yes

Remarks:

Dimethylformamide (DMF)

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)

Definitive Limit Test
A static definitive limit test was performed from 21 to 25 April 2014 at nominal concentrations of 0 (control), 0 (vehicle control), and 800 µg/L. Due to the functional solubility of the test substance, 800 µg/Lwas the maximum concentration tested. A primary stock solution was prepared for initiation at a concentration of 8.0 mg/mL by mixing0.0800 g of P1400 in 10mL of dimethylformamide (DMF). The 800 µg/L test solutions were prepared by diluting a 0.50 mL volume of the primary stock solution to a volume of 5.0 L with dilution water.The vehicle control was prepared by diluting 0.50 mL of DMF to a volume of 5.0 L with dilution water. The control consisted of dilution water only.

Test organisms (species):

Pimephales promelas

Details on test organisms:

TEST ORGANISM
- Common name: Fathead minnows
- Strain: not specified
- Source: in-house culture
- Age at study initiation (mean and range, SD): Juvenile
- Length at study initiation (length definition, mean, range and SD): 13 to 16 mm (mean and SD = 15 ± 1.0 mm)
- Weight at study initiation (mean and range, SD): 0.0147 to 0.0404 g in blotted wet weight (mean and SD = 0.0265 ± 0.0083 g)
- Method of breeding: Not specified

ACCLIMATION
- Acclimation period: at least 12 days before the definitive limit test initiation
- Acclimation conditions (same as test or not): Fathead minnows were maintained in the dilution water at the test temperature for at least 12 days before the definitive limit test initiation
- Type and amount of food during acclimation: brine shrimp, salmon starter, and a commercially available fish food at least one time daily.
- Feeding frequency during acclimation: fish were not fed for approximately 29 hours prior to initiation of the definitive limit test or during the subsequent test period
- Health during acclimation (any mortality observed): A daily record of fish observations during the culture period, along with any prophylactic or therapeutic disease treatments, was maintained. There was no mortality or treatments with prophylactics for two weeks prior to initiation of the study

FEEDING DURING TEST
- Food type: Fish were not fed during the test

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

152 mg CaCO3/L

Test temperature:

22.4 to 22.7°C

pH:

8.3 to 8.5

Dissolved oxygen:

7.6 to 8.4 mg/L (93 to 102% sat.)

Salinity:

158 mg CaCO3/L

Conductivity:

342 µS

Nominal and measured concentrations:

Nominal Concentrations: 0 (control), 0 (vehicle control), and 800 µg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 3.8-L glass jars (range finding test) or 10-L glass jars (definitive limit test)
- Type (delete if not applicable): closed (Each glass jar was covered with a clear Petri dish or glass lid (range finding test or definitive limit test, respectively))
- Material, size, headspace, fill volume: Glass
- Aeration: No
- Type of flow-through (e.g. peristaltic or proportional diluter): Not specified
- Renewal rate of test solution (frequency/flow rate): Not specified
- No. of organisms per vessel: Range Finding Test: 5 ish were added to each test chamber at test initiation; Definitive Limit Test: ten fish in each replicate test chamber
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 3
- No. of vessels per vehicle control (replicates): 3
- Biomass loading rate: 0.0530 g of fish tissue per liter of test solution

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: moderately hard freshwater prepared by blending naturally hard well water with well water that was demineralized by reverse osmosis (RO). Hardness: 130 to 160 mg CaCO3/L
Details available in Appendix B of study report.

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16-hr light:8-hr dark
- Light intensity: 780 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality; moribundity; behavior

TEST CONCENTRATIONS
- Spacing factor for test concentrations: several orders of magnitude
- Range finding study: 0 (vehicle control), 0.00010, 0.0010, 0.010, 0.10 and 1.0 µg/L
- Test concentrations: 0 (control), 0 (vehicle control), and 800 µg/L

Reference substance (positive control):

no

Remarks:

Test substance was reference substance

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

620 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

other: Lack of effects observed at highest achievable concentration tested

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 620 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

other: Lack of effects observed at the highest achievable concentration tested

Details on results:

- Behavioural abnormalities: After 96 hours of exposure, no mortalities were found in the control, vehicle control, and the 620 µg/L mean measured treatment solution. No sublethal effects were observed during the exposure.
- Observations on body length and weight: no effects
- Other biological observations: No effects
- Mortality of control: no mortality
- Other adverse effects control: no effects
- Abnormal responses: no effects
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: The control and all test substance treatment solutions were clear and colorless with no visible particulates, surface film, undissolved test substance, or precipitate throughout the test (the 0.10 µg/L test substance treatment solution was only observed at initiation due to discontinuance).

Reported statistics and error estimates:

Due to a lack of mortality and observed sublethal effects, no statistical analyses were performed. Estimates of LC50 and NOEC values were based on the highest achievable concentration tested.

Validity criteria fulfilled:

yes

Remarks:

No toxicity was observed within the water solubility level of the P1400

Conclusions:

Based on the mean measured concentration, the estimated 24-, 48-, 72-, and 96-hour LC50 were> 620 µg/L, the highest achievable concentration tested. The 96-hour NOEC was the highest measured concentration tested of 620 µg/L respectively, based on the lack of mortality and sublethal effects at this and all lower test substance concentrations.

Executive summary:

In a key 96-hour static toxicity test, fathead minnows (Pimephales promelas) were exposed to the test material (Santicizer Platinum P-1400 (P1400); CAS# 1200806-67-2; Purity: 100%. A  96-hour static range-finding  test  was  performed at  nominal concentrations of 0 (vehicle control), 0.00010, 0.0010, 0.010, 0.10 and 1.0 µg/L. The control and each test substance treatment were not replicated. Five fish were added to each test chamber at test initiation.  After 96hours, there was no mortality the 0 (control) and all test substance treatments except for the 0.10 µg/L test substance treatment. No sublethal effects were observed during the test.  

A static definitive limit test was subsequently performed at nominal concentrations of 0 (control), 0 (vehicle control), and 800 µg/L. Due to the functional solubility of the test substance, 800 µg/Lwas the maximum concentration tested. A primary stock solution was prepared for initiation at a concentration of 8.0 mg/mL by mixing 0.0800 g of P1400 in 10mL of dimethylformamide  (DMF).   The 800 µg/L test solutions were prepared by diluting a 0.50 mL volume of the primary stock solution to a volume of 5.0 L with dilution water.The vehicle control was prepared by diluting 0.50 mL of DMF to a volume of 5.0 L with dilution water. The control consisted of dilution water only.

The definitive limit test was conducted for 96 hours commencing when fish were added to the test chambers.  Test  fish  were  impartially  assigned  to  treatments  by  adding  one  fish  per  chamber proceeding from controls to the substance treatment chambers, and repeating steps as necessary until ten fish were present in each replicate test chamber. The control and test substance treatments were replicated as  A,  B,  and  C.   Observations  for  mortality  and  sublethal  responses  (e.g. loss of equilibrium, animals lying on the bottom of the test chamber, etc.) were made once every 24 hours (±1 hour) for the remainder of the test. Fish were not fed during the test.

After 96 hours of exposure, no mortalities were found in the control, vehicle control, and the 620 µg/L mean measured treatment solution. No sublethal effects were observed during the exposure.

Based on the mean measured concentration, the estimated 24-, 48-, 72-, and 96-hour LC50 were> 620 µg/L, the highest concentration tested. The 96-hour NOEC was the highest achievable measured concentration tested of 620 µg/L respectively, based on the lack of mortality and sublethal effects at this and all lower test substance concentrations.

Description of key information

Based on the mean measured concentration, the estimated 24-, 48-, 72-, and 96-hour LC50 were > 620 µg/L, the highest achievable concentration tested. The 96-hour NOEC was the highest measured concentration tested of 620 µg/L respectively, based on the lack of mortality and sublethal effects at this and all lower test substance concentrations.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

620 µg/L