Phosphoric acid, mono- and di-isotridecyl esters, compd. with 2,2'-iminobis[ethanol]

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Study period:

2006

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

Read across study

Justification for type of information:

Refer to the section 13 of the IUCLID dataset for details on the read across justification. The short term toxicity study to fish with the read across substance is considered sufficient to fulfil the information requirements.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: Environment Canada method, Biological Test Method: Acute Lethality Test Using Rainbow Trout, EPS 1/RM/9 (EC 1990/1996)

Deviations:

no

GLP compliance:

not specified

Analytical monitoring:

yes

Details on sampling:

- Concentrations: not specified, sampling at test initiation (0 h) and test end (96 h)
- Sampling method: no data
- Sample storage conditions before analysis: no data

Vehicle:

no

Details on test solutions:

No data

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

Test organisms:
- Common name: rainbow trout
- Strain: no data
- Source: no data
- Age at study initiation (mean and range, SD): no data
- Length at study initiation (length definition, mean, range and SD): mean fish length = 3.9 or 3.6 cm
- Weight at study initiation (mean and range, SD): mean fish weight = 0.49 or 0.38 g
- Method of breeding: no data
- Feeding during test: not applicable, no feeding during test, fish were starved for at least 12 h prior to test initiation

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

14 mg/L as CaCO3 (measured by EDTA titration)

Test temperature:

15±1°C

Nominal and measured concentrations:

Nominal: control and five test concentrations
Measured: 96-110% of nominal at test initiation and test end

Details on test conditions:

Test system:
- Test vessel: no further details
- Type (delete if not applicable): open (covered with plexiglass sheet
- Material, size, headspace, fill volume: plastic-lined glass aquarium (12 or 15 L)
- Aeration: 30 minutes prior to addition of the fish and during test
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.33 or 0.32 g/L

Test medium / test parameters
- Source/preparation of dilution water: dechlorinated and hardened Vancouver city tap water

Other test conditions:
- Adjustment of pH: no data
- Photoperiod: no data
- Light intensity: no data

Effect parameters observed (with observation intervals if applicable) :
- mortality
- behaviour

Reference substance (positive control):

yes

Remarks:

Phenol

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

460 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Remarks:

analytically verified

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% CL: 250-625 mg/L

Details on results:

- Mortality of control: 0%
- Other adverse effects control: none of control fish displayed loss of equilibrium or atypical swimming behaviour.
- Abnormal responses: no
- Effect concentrations exceeding solubility of substance in test medium: no

Results with reference substance (positive control):

- Results with reference substance valid? yes
- Other: Reference toxicant (positive control) tests were conducted with phenol with each batch of fish used, and the resulting LC50s were within two standard deviations of previous tests.

Reported statistics and error estimates:

Binomial option in “Bioassay Program”, a Lotus Notes-based application which implements a BASIC computer program obtained from Environment Canada that is based on calculations in Stephan, 1977, Methods for Calculating an LC50, in: Aquatic Toxicology and Hazard Evaluation (ASTM STP 634), Mayer and Hamelink (eds.), ASTM, Philadelphia, PA, pp. 65-84.

Validity criteria fulfilled:

yes

Conclusions:

Under the study conditions, the 96 h LC50 of the substance to rainbow trout was determined to be 460 mg a.i./L.

Executive summary:

A study was conducted to determine the short-term toxicity of the read-across substance 2,2’-iminodiethanol (diethanolamine) to fish according to the Environment Canada method, Biological Test Method: Acute Lethality Test Using Rainbow Trout, EPS 1/RM/9 (EC 1990/1996). Rainbow trout were exposed to the test substance at five concentrations for a period of 96 h under static test conditions. A negative control group with fish not exposed to the test substance as well as a positive control with phenol were included in the experiment. The number of mortalities and any sub-lethal effects of exposure in each test and control vessel were determined throughout the experiment. No mortality was observed during the experiment. Under the study conditions, the 96 h LC50 of the substance to rainbow trout was determined to be 460 mg a.i./L (Petroleum Technology Alliance Canada, 2006).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

A study was conducted to determine the acute toxicity of the read-across substance phosphoric acid, mono- and di-C12-18-(even numbered)-alkyl esters, sodium salts (mono- and di- C12-18 PSE, Na+) to fish according to OECD Guideline 203 and EU Method C.1, in compliance with GLP. Seven fish (Cyprinus carpio) per group were exposed to a control (medium alone) and to 100% of the saturated solution. The total exposure period was 96 h and the experiment was conducted under static conditions. Due to the complex nature of the test substance, specific analyses proved to be difficult to obtain and it was decided to analyse the Total Organic Carbon (TOC) concentration as a surrogate measure. Samples for TOC concentrations were taken at the start and after 24 and 96 h of exposure. The TOC analysis performed on samples taken from 100% of the saturated solution should be regarded as indicative because of the low carbon concentrations. Effect parameters were based on the percentages of the saturated solution prepared at a loading rate of 100 mg/L. No mortality or clinical effects were observed at the limit concentration and in the control during the test period. The responses recorded in this test allowed for reliable determination of an LL50. The study met the acceptability criteria prescribed by the study plan and was considered valid. Under the study conditions, the 96 h LL50 of the substance in Cyprinus carpio was determined to be greater than 100 mg/L (Bouwman, 2017).

A study was conducted to determine the short-term toxicity of the read-across substance 2,2’-iminodiethanol (diethanolamine) to fish according to the Environment Canada method, Biological Test Method: Acute Lethality Test Using Rainbow Trout, EPS 1/RM/9 (EC 1990/1996). Rainbow trout were exposed to the test substance at five concentrations for a period of 96 h under static test conditions. A negative control group with fish not exposed to the test substance as well as a positive control with phenol were included in the experiment. The number of mortalities and any sub-lethal effects of exposure in each test and control vessel were determined throughout the experiment. No mortality was observed during the experiment. Under the study conditions, the 96 h LC50 of the substance to rainbow trout was determined to be 460 mg a.i./L (Petroleum Technology Alliance Canada, 2006).