Rye, ext.

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Cross-reference

Reason / purpose for cross-reference:

read-across source

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

other information

Justification for type of information:

Cf the attached Read across argumentation

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

It concerns the number of replicates for the concentration 100 mg/L: 8 replicates instead of 4 r eplicates were done to have enough solution at the end of the test for the chemical analyses. This has no influence on the results of this study.

GLP compliance:

yes (incl. QA statement)

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: highest tested concentration

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: highest tested concentration

Details on results:

- No immobilization was observed at 24 h and 48 h (including controls).
- No sign of stress was observed on the mobile daphnids after 48 h of exposure

Results with reference substance (positive control):

The last toxic response obtained on the reference item K2Cr2O7 (March 24, 2016) gives an EC50-24h of 1.58 mg/L (1.44 – 1.76), indicating that the daphnids sensitivity is correct (within the accepted interval of 0.6–2.1 mg/L fixed by the International Standard ISO 6341 December 2012 as mentioned in the OECD 202 Guideline) and in accordance with historical data obtained by the laboratory

Validity criteria fulfilled:

yes

Conclusions:

The results obtained for the reference substance on the toxicological endpoint “immobilisation” give an EC50-24h and an EC50-48h higher than the highest tested concentration, i.e. 100 mg/L, based on nominal test item concentration.

Executive summary:

Based on the consideration mentioned in the attached argumentation, it can be concluded that the results of the study made on Daphnia magna, acute immobilization test performed on the reference substance “Polysaccharides of glucose from Oat” is likely to predict the properties of the target substance “Oligosaccharides and Polysaccharides of glucose from Rye” and are considered as adequate to fulfil the information requirement of the Annex VII 9.1.1: 1.   Short term toxicity to aquatic invertebrates:

=> EC50-24h and EC50-48h > 100 mg/L (highest tested concentration)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

It concerns the number of replicates for the concentration 100 mg/L: 8 replicates instead of 4 replicates were done to have enough solution at the end of the test for the chemical analyses. This has no influence on the results of this study.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Polysaccharids of kernel Avena sativa, Poaceae

EC Number:

944-507-3

IUPAC Name:

Polysaccharids of kernel Avena sativa, Poaceae

additive 1

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

oxidane

Test material form:

solid

Details on test material:

Osilift AT is the atomized product of Osilift
Appearance: clear beige powder
Storage conditions: 20°C in a dark place and protected from humidity
Batch number : 131121-0027
Expiration date: November 2016

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

In order to verify the initial concentrations and maintenance of the exposure concentrations of the test item during the ecotoxicological testing, chemical analyses in daphnids test solutions were performed according to the Analytical Protocol FCBA Chimie No.315-e version 2: Method for the chemical analysis of Total Organic Carbon (TOC) in samples containing the test item OSILIFT AT from daphnids ecotoxicology solutions by Total Organic Carbon Analyzer, (described in the study 15/1268F/b) and the following protocol:
- at the beginning of the test (T = 0h)
- at the end of the test (T = 48h)
- for the control (i.e. daphnids test medium filtered) and concentration 100 mg/L

These solutions were analysed taken directly from the starting solutions without daphnids.
At the end of the test (48h), the solutions were analysed with daphnids (biotic solutions) and without daphnids (abiotic solutions).

The measured concentrations of the test item should not vary more than ± 20 % during the test (48h).

Test solutions

Vehicle:

no

Details on test solutions:

The test item was soluble in the test medium.
At the request of the sponsor, the test medium and the solution (100 mg test item/L) were filtered through a membrane filter (cellulose acetate) with a mesh size of 0.22 μm to sterilizing and all the manipulations were done under sterile conditions to prevent contamination

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnia magna Straus, clone number 5, from at least the third generation (i.e. the third brood) obtained with a non-cyclic parthenogenesis reproduction.
The daphnids breeding was carried out in closed bottles placed in a climatic chamber free from any toxic vapour and in medium M4.
Daphnids used in this experimentation were previously filtered in order to obtain animals from a size between 560 μm and 800 μm (corresponding to daphnids less than 24 hours old).

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

none

Test conditions

Hardness:

250 mg/L of CaCO3

Test temperature:

18 - 22 °C

pH:

pH (Dilution water M4) = 8.2

Dissolved oxygen:

9.0 mg/L

Salinity:

no data

Nominal and measured concentrations:

Nominal concentration: 100 mg/L
Measured concentration: 98.5 mg/L (at initial time) and 97.95 mg/L (after 48 hours of exposure)

Details on test conditions:

TEST SYSTEM
Daphnia magna Straus, clone number 5, from at least the third generation (i.e. the third brood) obtained with a non-cyclic parthenogenesis reproduction.
The daphnids breeding was carried out in closed bottles placed in a climatic chamber free from any toxic vapour and in medium M4.
Daphnids used in this experimentation were previously filtered in order to obtain animals from a size between 560 µm and 800 µm (corresponding to daphnids less than 24 hours old).

The test will contain a minimum of 8 glass test tubes as follow:
• Control: 4 replicates
• Concentration 100.0 mg/l: 4 replicates
Each glass test tube (sterilized by autoclave) contained 10 mL of test solution and 5 daphnids; they were covered in order to avoid evaporation and dust deposition.


OTHER TEST CONDITIONS
- Light intensity: Darkness

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Observations of the daphnid’s mobility were done after 24 and 48 hours of exposition to the test item.
Every sign of stress observed on the daphnids after 48 hours of exposition to the test item were reported if need be.
pH and dissolved oxygen were measured at the beginning and at the end of the test for each test solutions (including the controls).

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: highest tested concentration

Effect concentrations 2

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: highest tested concentration

Details on results:

- No immobilization was observed at 24 h and 48 h (including controls).
- No sign of stress was observed on the mobile daphnids after 48 h of exposure

Results with reference substance (positive control):

The last toxic response obtained on the reference item K2Cr2O7 (March 24, 2016) gives an EC50-24h of 1.58 mg/L (1.44 – 1.76), indicating that the daphnids sensitivity is correct (within the accepted interval of 0.6–2.1 mg/L fixed by the International Standard ISO 6341 December 2012 as mentioned in the OECD 202 Guideline) and in accordance with historical data obtained by the laboratory

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The results obtained for the test item on the toxicological endpoint “immobilisation” give an EC50-24h and an EC50-48h higher than the highest tested concentration, i.e. 100 mg/L, based on nominal test item concentration.

Executive summary:

The aim of this study was to assess the effects of the test item “OSILIFT AT”on the daphnidsDaphnia magna, according to the OECD 202 guideline, at 100 mg/L, limit test, in static conditions.

 The concentrations which immobilise 50% of the daphnids exposed to the test item after 24 and 48 hours, reported as EC₅₀-24h and EC₅₀-48h were evaluated, relative to the tested concentration : 100 mg/L.

At the nominal concentration of 100 mg/L, the test item « OSILIFT AT» is considered as stable in the testing conditions because the measured concentrations of the “OSILIFT AT” did not vary more than ± 20 % of initial measured concentration during the test.

The results obtained for the test item “OSILIFT AT” on the toxicological endpoint “immobilisation” give an EC₅₀-24h and anEC₅₀-48h superior to the highest tested concentration,i.e. 100mg/L, value expressed in nominal test item concentration.