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Ecotoxicological information

Short-term toxicity to fish

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Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MEA Polyborate 1:3
- Molecular formula (if other than submission substance): UVCB - not applicable
- Physical state: Clear colourless liquid
- Composition of test material, percentage of components: 68% of active ingredient/non-water components
- Lot/batch No.: EU-SMG 01696
- Expiration date of the lot/batch: 02 April 2011 (allocated by NOTOX, 1 year after receipt
of the test substance)
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Cyprinus carpio
Details on test organisms:
TEST ORGANISM
- Common name: Carp
- Strain:
- Source: Zodiac, proefacc, "De Haar Vissen", Wageningen
University and Research Centre, The Netherlands.
- Age at study initiation (mean and range, SD): No data
- Length at study initiation (length definition, mean, range and SD): Final test: 2.3 ± 0.1 cm
- Weight at study initiation (mean and range, SD): Final test: 0.29 ± 0.05 g
- Feeding during test: Daily with pelleted fish food (Cyprico Crumble
Excellent (300-500 um), Coppens International bv,
Helmond, The Netherlands)


ACCLIMATION
- Acclimation period: at least 12 days after delivery


Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h

Test conditions

Test temperature:
20.7°C – 21.6°C
pH:
7.6 - 8.0
Dissolved oxygen:
6.1 - 8.6 mg/L
Salinity:
N/A
Nominal and measured concentrations:
Nominal: 100, 170, 320, 580, 1000 mg a.i./L
Measured: 147, 265, 476, 857, 1470 mg a.i./L
Details on test conditions:
TEST SYSTEM
- Test vessel: 10 litres, all-glass, containing 9.8 litres of test solution
- Aeration: The test media were not aerated during the test.
- No. of organisms per vessel: 7 per concentration

Adjusted ISO medium, formulated using RO-water
(tap-water purified by reverse osmosis; GEON
Waterbehandeling, Berkel-Enschot, The Netherlands)
with the following composition:
CaCl2.2H2O 211.5 mg/l
MgSO4.7H2O 88.8 mg/l
NaHCO3 46.7 mg/l
KCl 4.2 mg/l


OTHER TEST CONDITIONS
- Photoperiod: 16 hours photoperiod daily

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS
- Test concentrations: 100, 170, 320, 580, 1000 mg a.i./L

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
617 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: 95% CL 529 - 823 mg a.i./L
Details on results:
- Behavioural abnormalities: Fins contracted against the body, caudal fin closed. Fins slightly reddish with clearly enlarged blood vessels. Enhanced respiratory rate. Swimming at the surface (only at 48 hour of exposure)
- Mortality of control: 0

Applicant's summary and conclusion

Conclusions:
Under the conditions of the present test MEA Polyborate 1:3 induced no visible and or lethal
effects in carp at nominally 320 mg a.i./l (NOEC).
The 96h-LC50 was 617 mg a.i./l based on nominal concentrations (95% confidence interval
between 529 and 823 mg a.i./l). No 24, 48 or 72h-LC50 could be calculated (LC50 > maximum
concentration tested). This value is used as an estimate of the short-term or acute toxicity of the
test substance, per the OECD guidelines.
Executive summary:

96-Hour Acute Toxicity Study in Carp with MEA Polyborate 1:3. The study procedure described in this report was based on the OECD guideline No. 203, 1992. In addition, the procedures were designed to meet the test methods of the Commission Regulation (EC) No 440/2008, Part C.1, 2008 and the ISO International Standard 7346-1: Static method. MEA Polyborate 1:3, is a complex UVCB (Substance of Unknown or Variable composition or Complex reaction products and Biological materials) containing salt and non-salt compounds in rapid equilibrium. The test substance is prepared from monoethanolamine, borate compounds and water and contains 68% active ingredients/non-water components. The test substance was completely soluble in test medium at the concentrations tested. Preparation started with a concentration of 1000 mg active ingredient (a.i.)/l which corresponds to 1470 mg MEA Polyborate 1:3 per litre. No other treatment than magnetic stirring was needed to completely dissolve the test substance. The pH of the highest concentration was adjusted with 1M HCl. The lower test concentrations were prepared by subsequent dilutions of the highest concentration in test medium. A final test was performed based on the result of the range-finding test. Seven fish per group were exposed to a control and concentrations of 100, 170, 320, 580 and 1000 mg a.i./l corresponding to 147, 265, 476, 857 and 1470 mg MEA Polyborate 1:3 per litre, respectively. The total exposure time was 96 hours and samples for analytical confirmation of test concentrations were taken at the start and at the end of the test. Analyses were performed on samples taken from the nominal concentrations of 476, 857 and 1470 mg/l (i.e. 320, 580 and 1000 mg a.i./l). The concentrations of both boron and MEA were determined. Boron analyses: The corresponding nominal concentrations of boron in analysed samples were 55, 99 and 171 mg boron per litre, respectively. Analysis of the samples taken at the start of the final test showed that the actual concentrations were in agreement with nominal, 78-85% of nominal (note that the mean recoveries of the procedural recovery samples were between 83-88%). The measured concentrations remained stable during the entire test period (96-103% of initial). MEA analyses: The corresponding nominal concentrations of MEA in analysed samples were 81,146 and 250 mg MEA per litre, respectively. Analysis of the samples taken at the start of the final test showed that the actual concentrations were in agreement with nominal, i.e 118-125% of nominal and remained stable during the entire test period (95-102% of initial). Based on these results, the effect concentrations were expressed in terms of the nominal concentrations of the active ingredient. The study met the acceptability criteria prescribed by the protocol and was considered valid. The 96h-LC50 for MEA Polyborate 1:3 was 617 mg a.i./l based on nominal concentrations (95% confidence interval between 529 and 823 mg a.i./l). No mortalities were observed at 2, 24 and 48 hours, so no LC50 could be estimated. The maximum mortality observed at 72 hours was less than 50%, no no LC50 could be determined.