Reaction product of resin acid and rosin acid, 12-Hydroxyoctadecanoic and stearic acid with dipentaerythritol

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 Sept 2007 - 10 Jan 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

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: 7-2-A
- Expiration date of the lot/batch: April 2010
- Purity test date: not stated

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature at about 20 °C, away from direct sunlight.
- Stability under test conditions: not stated
- Solubility and stability of the test substance in the solvent/vehicle: insoluble in water

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: none
- Preliminary purification step (if any): none
- Final dilution of a dissolved solid, stock liquid or gel: 250.5 mg Salacos 168 ARV in 2500 mL test water, WAF used

Analytical monitoring:

yes

Details on sampling:

For the 48-hour stability samples, additional flasks with adequate volumes of the freshly prepared test medium and of the control were incubated during the test period under the same conditions as in the actual test. Sampling from the test beakers with daphnids was not possible because the test medium volume per beaker (50 mL) was too small for the analytical requirements.
All samples were stored deep-frozen (at about -20 °C) immediately after sampling.

Vehicle:

no

Details on test solutions:

In order to assess the toxicity to daphnids of the test item containing different components, a water accommodated fraction (WAF) with the loading rate of 100 mg/L was prepared by mixing 250.5 mg of the test item into 2500 ml of test water using ultrasonic treatment for 15 minutes at room temperature in the dark. The dispersion was stirred for 96 hours to dissolve a maximum amount of the different compounds of the test item in the dispersion. Then, the dispersion was filtered through a membrane filter (0.45 µm pore size) and the undiluted filtrate was tested as WAF.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Strain/clone: Daphnia magna Straus
- Justification for species other than prescribed by test guideline:
- Source: University of Sheffield
- Age of parental stock (mean and range, SD): 6-24 hours
- Feeding during test no
- Food type: none feed
- Amount: none feed
- Frequency: none feed

ACCLIMATION
no acclimation

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

2.5 mmol/L

Test temperature:

21 °C

pH:

7.9

Dissolved oxygen:

8.1 - 8.7 mg/L

Nominal and measured concentrations:

nominal: 100 mg/L loading rate for WAF
measured: LOQ

Details on test conditions:

TEST SYSTEM
- Test vessel: 100 ml glass beakers
- Type (delete if not applicable): not stated
- Material, size, headspace, fill volume: glass, 100 ml, 50 ml test medium
- Aeration: not stated
- Type of flow-through (e.g. peristaltic or proportional diluter): no flow through
- Renewal rate of test solution (frequency/flow rate): no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): 4
- Biomass loading rate: not stated

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: not stated
- Total organic carbon: not stated
- Particulate matter: not stated
- Metals: not stated
- Pesticides: not stated
- Chlorine: not stated
- Alkalinity: not stated
- Ca/mg ratio: 4
- Conductivity: not stated
- Salinity: not stated
- Culture medium different from test medium: no
- Intervals of water quality measurement: not stated

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light, 8 hours dark
- Light intensity: 490 to 650 Lux

Reference substance (positive control):

no

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat. (total fraction)

Remarks:

Water accomodated fraction

Basis for effect:

mobility

Reported statistics and error estimates:

no statistics performed

Validity criteria fulfilled:

yes

Conclusions:

In conclusion, the test item Salacos 168 ARV had no acute toxic effects to Daphnia magna up to its solubility limit in test water under the present test conditions.

Executive summary:

The acute toxicity of the test item Salacos 168 ARV to Daphnia magna was deteermined in a 48 hour static test according to the EUCommission Directive 92/69/EEC, Part C.2 (1992) and the OECD Guideline for Testing of Chemicals, No. 202 (2004).

A limit test was performed in compliance with the test guidelines to demonstrate that water accommodated fractions (WAFs) of the test item have no toxic effect on Daphnia magna up to the loading rate of 100 mg/L. Thus, the only concentration tested was a WAF with the loading rate of 100 mg/L. Additionally, a control (test water without test item) group was tested in parallel. The test method was based on the OECD Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, 2000.

For the preparation of the test medium, a dispersion was stirred for 96 hours to dissolve a maximum amount of the different compounds of the test item in the dispersion. Then, the dispersion was filtered through a membrane filter (0.45 µm pore size) and the undiluted filtrate was tested as WAF.

The analytically measured test item concentration in the test medium was below the limit of quantification (0.1 mg/L) at the beginning and the end of the test period of 48 hours. Since a WAF of the test item with sparingly solublecomponents was tested, all reported biological results are based on the loading rate of 100 mg/L.

In the control and at the loading rate of 100 mg/L, no immobilized daphnids were determined during the test period of 48 hours.

The 48 hours NOEC (highest concentration tested without toxic effects after the exposure period of 48 hours) of Salacos 168 ARV to Daphnia magna were determined to be at least at the loading rate of 100 mg/L. These values might even be higher but loading rates in excess of 100 mg/L were not tested, in accordance with the test guidelines. The 48 hour EC50 and the 48 hour EC100 were clearly higher than the loading rate of 100 mg/L. These values could not be quantified due to the absence of toxictiy of Salacos 168 ARV at the loading rate of 100 mg/L.

Description of key information

One Guideline Study performed. Water accomodated Fractions with loading rates up to 100 mg/l tested.

No toxic effects observed up to the highest loading rate.

Key value for chemical safety assessment:

EC50, EC10 > 100 mg/L, 100 mg/L entered in respective field below

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L