Reaction products of 1,6-diisocyanatohexane, oligomers with 2-[(2-methacryloyl)oxy]ethyl 6-hydoxyhexanoate and 2-hydroxyethyl methacrylate

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:

16-Nov-2009 to 20-Nov-2009

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was performed in accordance with internationally-accepted test guidelines and Good Laboratory Practice standards. However, the test substance could not be quantified in the WAF. Therefore, this study is classified as acceptable with restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EU Commission Directive 92/69/EEC, C.2, Acute Toxicity for Daphnia. Commission Regulation (EC) No 440/2008, C.2, Acute Toxicity for Daphnia. Also, design and execution of the study were based in part on OECD document 23, Guidance Document on Aquatic To

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): MTDID 8191
- Substance type: UVCB material
- Physical state: Yellowish viscous liquid
- Concentration of oligomers: ≥99.0%
- Purity test date: 21 January 2010
- Lot/batch no.: MK 12/048
- Expiration date of the lot/batch: 27-Jan-2010
- Stability under test conditions: Not reported
- Storage condition of test material: In the refrigerator at about 4 °C
- Other:

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
No surrogate

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Sampling method: After manual shaking, withdrawal of aliquot and dilution with an equal volume of acetonitrile.
- Sample storage conditions before analysis: Samples analyzed immediately

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Dispersions were stirred for 96 hours at room temperature in the dark to dissolve a maximum amount of the test item in the dispersion. After stirring, the dispersions were left to settle for 1 hour and the clear phase of each dispersion was then filtered through a membrane filter (Schleicher & Schuell, Type NC45, pore size 0.45 µm). The undiluted filtrates were tested as water accomodated fractions (WAFs).
- Evidence of undissolved material (e.g. precipitate, surface film, etc): None

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea
- Strain:Daphnia magna Straus, clone 5
- Source: internal strain originally obtained from University of Sheffield, UK in 1992
- Age at study initiation (mean and range, SD): 6-24 hours
- Feeding during test: No

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Hardness:

250 mg/L-CaCO3

Test temperature:

20 °C

pH:

7.8

Dissolved oxygen:

8.4-8.6 mg/L

Salinity:

Not reported

Nominal and measured concentrations:

nominal concentration, 100 mg/L. Test substance could not be quantified

Details on test conditions:

TEST SYSTEM
- Test vessel: 100 mL glass beaker
- Type (delete if not applicable): covered with glass plate
- Material, size, headspace, fill volume: 50 mL test medium, ca. 50 mL headspace
- Aeration: none
- Renewal rate of test solution (frequency/flow rate): static test
- No. of organisms per vessel: five
- No. of vessels per concentration (replicates): four
- No. of vessels per control (replicates): four
- Biomass loading rate: 1 organism/10 mL

GROWTH MEDIUM
- Standard medium used: yes, ISO 6341 medium

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: purified water
- Total organic carbon: Not reported
- Particulate matter: Not reported
- Metals: Not reported
- Pesticides: Not reported
- Chlorine: Not reported
- Alkalinity: 0.8 mmol/L
- Ca/mg ratio: 4:1
- Conductivity: Not reported
- Culture medium different from test medium: No
- Intervals of water quality measurement: Not reported

OTHER TEST CONDITIONS
- Adjustment of pH: None
- Photoperiod: 16-hour light to 8-hour dark cycle with a 30-minute transition period
- Light intensity: 520 and 680 Lux during the light period

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Parameter: Immobilization
- Observation intervals: At 24 and 48 hrs
- Criterion: Daphnids not being able to swim within 15 seconds after gentle agitation of the test beaker are considered to be immobilized

TEST CONCENTRATIONS
- Spacing factor for test concentrations: Limit test
- Range finding study: Yes, results not reported (non-GLP)

Reference substance (positive control):

yes

Results and discussion

Effect concentrations

Duration:

48 h

Dose descriptor:

NOELR

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: water accomodated fraction

Basis for effect:

mobility

Remarks on result:

other: No immobilization was observed in treated vessels or controls during the experiment

Details on results:

- Behavioural abnormalities: Not reported
- Observations on body length and weight: Not reported
- Other biological observations: Not reported
- Mortality of control: None
- Other adverse effects control: None
- Abnormal responses: None
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: Test substance could not be quantified in test solutions (LOQ = 1.01 mg/L). The test medium was a clear solution through the 48-hours of exposure.
- Effect concentrations exceeding solubility of substance in test medium: No effect detected at an initial nominal loading of 100 mg/L.

Results with reference substance (positive control):

For evaluation of the quality of the daphnia clone and the experimental conditions, potassium dichromate is tested as a positive control twice a year. The result of the latest positive control test in September 2009 (48-hour EC50: 1.1 mg/L, study C63680) indicated that the sensitivity of the test organisms was within the internal historical range (48-hour EC50 from 1996 to 2009: 0.53-1.1 mg/L).

Reported statistics and error estimates:

No statistics. NOELR and EL50 determined from raw data

Any other information on results incl. tables

Table 2, Effect of the test substance on the mobility ofDaphnia magna
Loading rate (mg/L)	Number of daphnids tested	Immobilized daphnids after
		24 hours		48 hours
		Number	%	Number	%
Control (0)	20	0	0	0	0
100	20	0	0	0	0

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The NOELR of the test substance under assay conditions was 100 mg/L

Executive summary:

The test substance (CAS# 1101874-33-2) is a UVCB substance of low water solubility. Therefore, toxicity of the substance to the aquatic invertebrate Daphnia magna was determined in a limit test using a water-accommodated fraction (WAF). No immobilization was observed after 48 hours. Therefore, the no observed effect loading rate was 100 mg/L, and the effective loading rate (50%, or EL50) was >100 mg/L.

The study demonstrates was performed in accordance with internationally-accepted test guidelines and Good Laboratory Practice standards. However, the test substance could not be quantified in the WAF. Therefore, this study is classified as acceptable with restrictions.