2,2-dimethyl-1,3-dioxolan-4-ylmethanol

Toxicity to soil macroorganisms except arthropods

Link to relevant study record(s)

Reference

Endpoint:

toxicity to soil macroorganisms except arthropods: long-term

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Study iniation date : July13, 2017. Study completion date (Final report) : November 02,2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 222 (Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Study type:

laboratory study

Substrate type:

artificial soil

Limit test:

no

Total exposure duration:

56 d

Test temperature:

18.2-21.4 °C

pH:

Soil pH-value (day 0) : 5,6-5,7; Soil pH-value (day 56) :6,6-6,7.

Moisture:

Soil moisture (day0) : 50,4-55,5%; Soil moisture (day 56) : 63.3-67.9%

Nominal and measured concentrations:

Nominal concentrations : 62,5-125,250,500,1000 mg:kg dw.

Reference substance (positive control):

yes

Remarks:

Boric Acid

Key result

Duration:

28 d

Dose descriptor:

NOEC

Effect conc.:

> 1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Key result

Duration:

28 d

Dose descriptor:

NOEC

Effect conc.:

> 1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth

Key result

Duration:

56 d

Dose descriptor:

NOEC

Effect conc.:

250 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Key result

Duration:

56 d

Dose descriptor:

EC50

Effect conc.:

> 1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Reported statistics and error estimates:

Related to growth, the statistical analysis showed no significant difference (using Dunnet's test; p<= 0.05). Related to reproductio, the statistical analysis (Williams t-test, p<=0,05) showed a statistical difference concernig the number of juveniles between the control and the effects of 500 and 1000 mg test item/kg soil dw.

Concentration [mg test item/kg soil (dw)]	Adult mortality [%]	Biomass [Mean change in % of the initial weight per replicate]	Number of Juveniles [% of Control]
Control	0.0	19.2	-
62.5	0.0	20.0	93.5
125	0.0	19.0	101.6
250	0.0	23.7	98.0
500	0.0	23.9	75.1*
1000	0.0	27.5	64.3*
NOEC [mg test item/kg soil (dw)]	≥ 1000	≥ 1000	250
LOEC [mg test item/kg soil (dw)]	> 1000	> 1000	500
EC50 [mg test item/kg soil (dw)]	-	-	n.d.
* Statistically significant different to Control (Williams t-test, p = 0.05, one-sided)
- = not applicable, n.d. = not determinable.

Validity criteria fulfilled:

yes

Conclusions:

All validity criteria defined in the test guidelines were fulfilled.
No mortality was observed throughout all test vessels after 28 days. Hence, no statistical analysis was performed and the NOECMortality was regarded to be ≥1000 mg test item/kg soil dw (the highest concentration of the test item tested). The LOECMortality could not be determined and was regarded to be >1000 mg test item/kg soil dw.
Statistical analysis showed no significant difference (Dunnett’s test, 2-sided; p≤0.05) concerning biomass development of individual adults over 28 days between the control and all concentrations of the test item tested.
Therefore, the NOECBiomass was determined as ≥1000 mg test item/kg soil dw (the highest concentration of the test item tested). The LOECBiomass could not be determined and was regarded to be >1000 mg test item/kg soil dw.
Statistical analysis (Williams t-test; 1-sided, p≤0.05) showed a significant difference concerning the number of juveniles between the control and the concentrations of 500 and 1000 mg test item/kg soil dw. Therefore, the NOECReproduction was determined as 250 mg test item/kg soil dw. Accordingly, the LOECReproduction was determined as 500 mg test item/kg soil dw.
Since inhibition of reproduction was <50%, no EC50 value was calculated; the EC50 was regarded to be >1000 mg test item/kg soil dw.

Executive summary:

No significant chronic toxicity has been observed at lower concentration than 1000 mg/kg dw ( according to mortality and biomass parameters) , and 250 mg/kgdw ( according to reproduction parameter).

Description of key information

All validity criteria defined in the test guidelines were fulfilled.

No mortality was observed throughout all test vessels after 28 days. Hence, no statistical analysis was performed and the NOECMortality was regarded to be ≥1000 mg test item/kg soil dw (the highest concentration of the test item tested). The LOECMortality could not be determined and was regarded to be >1000 mg test item/kg soil dw.

Statistical analysis showed no significant difference (Dunnett’s test, 2-sided; p≤0.05) concerning biomass development of individual adults over 28 days between the control and all concentrations of the test item tested.

The NOECBiomass was determined as ≥1000 mg test item/kg soil dw (the highest concentration of the test item tested). The LOECBiomass could not be determined and was regarded to be >1000 mg test item/kg soil dw.

Since inhibition of reproduction was <50%, no EC50 value was calculated; the EC50 was regarded to be >1000 mg test item/kg soil dw.

No significant chronic toxicity has been observed at lower concentration than 1000 mg/kg dw ( according to mortality and biomass parameters) , and 250 mg/kgdw ( according to reproduction parameter).

Key value for chemical safety assessment

Short-term EC50 or LC50 for soil macroorganisms:

1 000 mg/kg soil dw

Long-term EC10, LC10 or NOEC for soil macroorganisms:

250 mg/kg soil dw