1,2-Cyclohexanedicarboxylic Acid, 1-(phenylmethyl) ester, ester with 2,2,4-trimethyl, 1,3-petanediol mono(2-methyl propanoate)

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP compliant study, no standard guideline used. Limitations on reporting. High solvent concentration used.

Justification for type of information:

The justification for read across is provided as an attachment in IUCLID Section 13.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

other: American Public Health Association. 1975. Standard Methods for the Examination of Water and Wastewater. 14th ed., New York.

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Methods of Acute Toxicity Tests with Fish, Macroinvertebrates and Amphibians. Stephan, C. E., Chairman. 1975, Committee on Methods for Toxicity Tests with Aquatic Organisms. U.S. EPA, Ecol. Res. Ser. 660/3-75009.

Deviations:

no

Principles of method if other than guideline:

48 hour static toxicity test on Daphnia magna. Acetone used as vehicle.

GLP compliance:

yes

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
Not applicable

Analytical monitoring:

no

Details on sampling:

Not applicable

Vehicle:

yes

Details on test solutions:

Solutions of the test substance were prepared with acetone as a vehicle. Maximum solvent concentratinon 1 mL per 200 mL beaker.

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnia magna, first instar (less than 24 hours old)

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Post exposure observation period:

No

Hardness:

255 ppm

Test temperature:

20 ± 1.0 °C

pH:

7.9 at test termination

Dissolved oxygen:

9.2 mg/L at test termination

Salinity:

Not applicable

Nominal and measured concentrations:

control, solvent control, 1.0, 1.8, 3.2, 5.6, 10 mg/L. All values nominal.

Details on test conditions:

TEST SYSTEM
- Test vessel: 250 mL glass beakers filled with 200 mL water
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- No. of vessels per vehicle control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ABC well water
- Conductivity: 50 µmhos/cm
- Culture medium different from test medium: No

OTHER TEST CONDITIONS
- Photoperiod: 16 hrs light, 8 hrs dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality at 24 and 48 hours.

TEST CONCENTRATIONS
- Range finding study: Yes
- Test concentrations: Factors of 10 from 0.1 mg/L till effect observed.
- Results used to determine the conditions for the definitive study: Yes

Reference substance (positive control):

no

Key result

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

7.5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 95% CL: 6.6-8.5 mg/L

Details on results:

No further details

Results with reference substance (positive control):

Not applicable

Reported statistics and error estimates:

Not reported

Validity criteria fulfilled:

yes

Remarks:

Report states that water quality parameters were within acceptable levels.

Conclusions:

The 48 hr static toxicity of the substance to Daphnia magna was 7.5 mg/L. Acetone was used as a vehicle in this test at concentrations of up to 5 mL/L

Executive summary:

A GLP compliant static toxicity test found that 48 hr static toxicity of the substance to Daphnia magna was 7.5 mg/L. Acetone was used as a vehicle in this test at concentrations of up to 5 mL/L.

Description of key information

This data is read across from the source dossier that tested Santicizer S278 ( benzyl 3-(isobutyryloxy)-1-isopropyl-2,2-dimethylpropyl phthalate) based on analogue read across. A discussion and report on the read across strategy is provided as an attachment in Section 13 of the dossier.

In a 48 -hour study in Daphnia magna reported a 48 hr LC50 of 7.5 mg/L. The levels tested (and the resulting effect level) were greatly in excess of the water solubility of the substance. A high amount of acetone was used as a solvent in this study and there are limitations on reporting. The application of the test item with solvent was not the same method that is recommended in the OECD guidelines but the study did include a solvent control, which confirms that the measured effects were test item related. This study is acceptable for use as a key study towards the conclusion that there is no short-term effect on aquatic invertebrates at the limit of solubility of the substance.