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Long-term toxicity to fish

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Endpoint:
fish early-life stage toxicity
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
A fish early life stage study in accordance with OECD 210 has been started 29 September, with an expected date of the draft report mid-January. The study was delayed due to difficulties in the development of an analytical method, as well as difficulties with the solubility/stability. The study protocol as well as statements addressing the above mentioned difficulties have been included as references in this record. An updated dossier with the final report is expected at the end of Q1, 2022. An update of the dossier containing the final study results will be submitted when all ongoing/planned studies have been finalized (expected in Q1 2022).
Endpoint:
fish early-life stage toxicity
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Minor resitricitons in design and/or reporting but otherwise adequate for assessment.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
The dilution water was a synthetic medium, Dutch Standard Water according to NPR 6507, containing 100 mg Na HCO3/l, 20 mg KHCO3/l, 200 mg CaCl2.2H2O/l and 180 mg MgSO4. 7H2O/l. The pH is approximately 8.2, the hardness 13 dH. The medium was aerated before use.

Test media of the water-soluble test stubstances were prepared by dissolving the test substance in the dilution water. For the poorly water-soluble substances, a stock solution in acetone or DMSO was made, from which a second stock solution in dilution water was prepared. As the water solubility of most test substances was unknown, the calculations are based on nominal concentrations. The test substances did not always solve well in the dilution water and formed dispersions. Where nominal concentrations exceed the water saturation values, the nominal cocnetrations should be interpreted accordingly. The pH, oxygen concentration and temperature were measured and adjusted if necessary, before the test animals were introduced in the medium.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Brachydanio rerio (new name Danio rerio) were obtained form a local aquarium retailer and kept in the laboratory at 24 C, males and females in separate groups. They were bred at regular intervals: in the afternoon females were isolated in small tanks filled with a mesh bottom at 26 C. After a few hours two males were introduced before the lights went off. In hte morning after the lights were turned on, eggs were produced. Each batch of eggs was collected from the bottom of the tank by a small fishing net and transferred to a small volume of water. White and opaque eggs and empty shells were removed and the quality of the batch and their stage of development was assessed. For each test eggs of only one female were used to insure a more homogeneous population of test eggs. On several occassions, test were repeated, enabling to compare the sensitivity of batches of different origin.

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
8 d
Post exposure observation period:
none
Hardness:
200 mg CaCO3/l
Test temperature:
not specified in report
pH:
8.2
Dissolved oxygen:
saturated
Salinity:
not applicable
Nominal and measured concentrations:
nominal concentrations: 0.1, 0.32, 1, 3.2, 10 mg/l
Details on test conditions:
Test containers were polystyrene multi-dishes with 6 holes each containing 5 ml of test mediu. Five to 7 eggs were transferred to each hole by means of a glass tube equiped with a rubber bulb. CS2- solutions were tested in glass tubes with air-tight teflon-tapered screw caps. The eggs were introduced in the tubes in 5 ml of dilution medium before 25 ml of CS2-solution was added to reach the final concentrations. Incubation started within 4 hours after spawning (gastrula stage). The eggs were incubated at 25 C under artificial light during working hours. Daily observations were made on survival of eggs and larvae, hatching and malformations. Dead organisms were removed. The test was semi-static: the medium was renewed after two or three days. Oxygen concentration, pH and temperature were measured to confirm that test conditions were normal. The NOEC concentrations for survival, hatching and malformations were determined graphically.
Reference substance (positive control):
no
Key result
Duration:
8 d
Dose descriptor:
NOEC
Effect conc.:
0.1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
number hatched
Duration:
8 d
Dose descriptor:
NOEC
Effect conc.:
> 10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
8 d
Dose descriptor:
NOEC
Effect conc.:
> 10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: malformations
Results with reference substance (positive control):
not applicable

Description of key information

A fish early life stage study in accordance with OECD 210 has been started 29 September 2021, with an expected date of the draft report mid-January 2022. The study was delayed due to difficulties in the development of an analytical method, as well as difficulties with the solubility/stability.

Key value for chemical safety assessment

Additional information

A fish early life stage study in accordance with OECD 210 has been started 29 September 2021, with an expected date of the draft report end of mid-January 2022. Based on this schedule, an updated dossier with the final report is expected at the end of Q1, 2022. An update of the dossier containing the final study results will be submitted when all ongoing/planned studies have been finalized (expected in Q1 2022). The study was delayed due to difficulties in the development of an analytical method, as well as difficulties with the solubility/stability. 

One long-term toxicity study with freshwater fish is available for zinc bis(dibenzyldithiocarbamate) and is used as supproting study for this endpoint. The study is a semi-static non-GLP test, which follwoed a protocol similar to OECD TG 210. The study was carried out on Danio rerio (tested as Brachydanio rerio) without analytical monitoring (Akzo Nobel Research Laboratories, 1991). The 8-d NOEC was determined to be 100 µg/L.