Reaction mass of propylidynetrimethanol and 2-ethylpropane-1,3-diol and 5-ethyl-1,3-dioxane-5-methanol

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Remarks:

Preliminary study

Adequacy of study:

key study

Study period:

13th August to 3rd September 2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

GLP compliance:

no

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: N/A
- Purity, including information on contaminants, isomers, etc.: N/A
- Composition: 5-ethyl-5-hydroxymethyl-1,3-dioaxane (CAS no. 5187-23-5) (25-60 %), 1,3-Propandiol, 2-ethyl (CAS no. 2612-29-5) (20-50 %), 2-ethyl-2-hydroxymethyl-1,3-propanediol (CAS no. 77-99-6) (15-25 %)

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: sealed containers, room temperature, dark
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: stable for at least 6 months
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis: N/A
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: soluble
- Reactivity of the test material with the incubation material used (e.g. plastic ware): N/A

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding): N/A
- Final concentration of a dissolved solid, stock liquid or gel: N/A
- Final preparation of a solid: 100 g of Polyol TD was dissolved per 1 l of aerated dilution water as a stock solution

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Age at study initiation (mean and range, SD): juvenile Daphnia (< 24h at test initiation)
- Weight at study initiation (mean and range, SD):
- Length at study initiation (length definition, mean, range and SD):
- Stage and instar at study initiation: 1st instar
- Method of breeding: Daphnia magna came from Fera’s in house cultures where they are cultured continuously in M4 media on a diet of Chlorella vulgaris.

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

21 d

Hardness:

220 - 270 mg CaCO3/L

Test temperature:

18.8 - 19.5°C

pH:

7.8 - 8.6

Dissolved oxygen:

8.8 to 10.1 mg/L

Nominal and measured concentrations:

Control, and single concentration at 62 mg/L (nominal)

Details on test conditions:

TEST SYSTEM
- Test vessel: glass baker
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: no data
- Aeration: No
- Type of flow-through (e.g. peristaltic or proportional diluter): N/A
- Renewal rate of test solution (frequency/flow rate): three times a week
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10

TEST MEDIUM / WATER PARAMETERS
Elendt M4, described in the OECD Revised Guideline No. 211 Appendix (ANNEX 2), was used.
- Culture medium different from test medium: No


OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: indoor light, 16 hours (at less than 1200 lux)/ 8 hours darkness

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Daphnia survival and juvenile production

TEST CONCENTRATIONS
- Spacing factor for test concentrations: N/A; limit test
- Justification for using less concentrations than requested by guideline: Appropiate concentration was determined in an acute toxicity test
- Range finding study: No
- Results used to determine the conditions for the definitive study: see above

Reference substance (positive control):

no

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

62 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Validity criteria fulfilled:

yes

Conclusions:

In the present invertebrate reproduction study the NOEC (cummulative offspring numbers) was determined to be 62 mg/L.

Executive summary:

The 21-day-chronic toxicity of the test substance (reaction mass of 2-ethylpropane-1,3-diol and 5-ethyl-1,3-dioxane-5-methanol and propylidynetrimethanol) to Daphnia magna was studied under semi-static conditions in a preliminary study according to OECD 211. Daphnids were exposed to control and a single concentration of 62 mg/L (nominal). The 21-day NOEC based on cumulative offspring numbers was 62.0 mg a.i./L.

This study is classified as acceptable and satisfies the guideline requirements for a chronic toxicity study with freshwater invertebrates.

Results synopsis

Test organism age: D. magna; < 24 h; 1^st instar

Test type: semi-static

NOEC: 62.0 mg/L

Endpoint(s) effected: Mortality, cumulative number of offspring, and reproductive performance

Description of key information

The chronic toxicity of the test substance (reaction mass of 2-ethylpropane-1,3-diol and 5-ethyl-1,3-dioxane-5-methanol and propylidynetrimethanol) was tested in a 21 -days Daphnia magna repoduction test according to OECD 211 (2012). The study was performed as a limit test using a test concentration of 62 mg/L. No statistically significant effect at the limit concentration could be observed. The 21-day NOEC was determined to be 62.0 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

NOEC

Effect concentration:

62 mg/L