Reaction mass of 1-[(1R*,6S*)-2,2,6-trimethylcyclohexyl]hexan-3-ol and 1-[(1S*,6S*)-2,2,6-trimethylcyclohexyl]hexan-3-ol

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:

2018-10-19 to 2018-12-13

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))

Version / remarks:

2016

Deviations:

yes

Remarks:

Food was provided on day 0 instead of day 1 due to good experience. At test end, the soil moisture deviated > 10 % from the initial value in all treatments. These deviations are considered to have no impact on results of the study.

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Details on test organisms:

TEST ORGANISM
- Common name: earthworm
- Age at test initiation: adult earthworms (with clitellum) aged 2 - 12 months
- Weight at test initiation: 0.37 to 0.54 g

ACCLIMATION
- Acclimation period: one day prior to test start
- Acclimation conditions: same as test
- Health during acclimation, any mortality observed: no

Study type:

laboratory study

Substrate type:

artificial soil

Limit test:

no

Total exposure duration:

8 wk

Test temperature:

20 + /-2 °C

pH:

day 0: 5.77-6.16
day 55: 5.90-6.15

Moisture:

Throughout the test the replicates were weighed weekly. Evaporated water was replenished by adding demineralised water to maintain the soil moisture which should not deviate by more than 10% of the initial value at the end of the test.

Details on test conditions:

TEST SYSTEM
- Test container: Test units, containing about 600 g soil dry weight, were glass vessels (volume 1.5 L, used for preserving). One transparent and perforated lid and one additional transparent lid enabled sufficient gas exchange and light input thereby preventing the test substrate from drying.
- No. of organisms per container: 10
- No. of replicates per treatment group: 4
- No. of replicates per control: 8
- No. of replicates per vehicle control: 8

OTHER TEST CONDITIONS
- Photoperiod: 16 h
- Light intensity: 511 +/- 89.7 lx

EFFECT PARAMETERS MEASURED:
A) no obvious pathological symptoms
B) no reaction to touching
C) no negative phototactical reaction
D) spontaneous segmentation and separation
E) spasmodic winding
F) yellow excretion from the oral aperture
G) ulcer and skin bleedings
H) dead earthworms (mortality)
I) number of juveniles produced
J) body weight

Nominal and measured concentrations:

Nominal concentration: 2.81 – 5.63 – 11.25 – 22.5 – 45 – 90 – 180 – 360 mg /kg soil dry weight (SDW)

Reference substance (positive control):

yes

Key result

Duration:

8 wk

Dose descriptor:

EC10

Effect conc.:

72.1 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Duration:

8 wk

Dose descriptor:

NOEC

Effect conc.:

90 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Duration:

8 wk

Dose descriptor:

NOEC

Effect conc.:

>= 360 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks:

mortality and biomass

Details on results:

Please refer to respective tables under "any other information on results including tables"

Results with reference substance (positive control):

Results with reference substance valid: yes

Validity criteria fulfilled:

yes

Conclusions:

The EC10 (reproduction) of the test item to earthworm (Eisenia fetida) was determined to be 72.1 mg/kg soil dry weight.

Executive summary:

The long term effect of the test item to soil macroorganisms (earthworm: Eisenia fetida) was determined according to OECD guideline 222 (2016) under GLP. The study was conducted under static conditions over 8 weeks with the test item concentrations 2.81 – 5.63 – 11.25 – 22.5 – 45 – 90 – 180 – 360 mg test item/kg soil dry weight (SDW). A control using untreated artificial soil was tested under the same conditions as the test item treatments. For the control 80 test organisms were inserted into 8 replicates. 40 test organisms were divided into 4 replicates for each treatment (10 earthworms per replicate). After 28 days of exposure in soil, neither evident earthworm mortalities (< 10 %) nor evident pathological symptoms or changes in the behaviour of adult earthworms were observed in the controls and all test item concentrations. There were no statistically significant differences in earthworm body weights at all test item concentrations compared to the control. After a further four weeks, the reproduction rate (average number of juveniles produced) was 112 in the control and ranged from 34 to 96 in the test item treatment rates. There was no statistically significant difference in earthworm reproduction in the treatment rates 2.81 to 90 mg /kg SDW compared to the control. However, at the test item concentrations 180 and 360 mg/kg SDW the earthworm reproduction was statistically significantly reduced. After 8 weeks, the EC10 (reproduction) of the test item to earthworm (Eisenia fetida) was determined to be 72.1 mg/kg soil dry weight.

Key value for chemical safety assessment

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

72.1 mg/kg soil dw

Additional information

The long term effect of the test item to soil macroorganisms (earthworm: Eisenia fetida) was determined according to OECD guideline 222 (2016) under GLP. The study was conducted under static conditions over 8 weeks with the test item concentrations 2.81 – 5.63 – 11.25 – 22.5 – 45 – 90 – 180 – 360 mg test item/kg soil dry weight (SDW). A control using untreated artificial soil was tested under the same conditions as the test item treatments. For the control 80 test organisms were inserted into 8 replicates. 40 test organisms were divided into 4 replicates for each treatment (10 earthworms per replicate). After 28 days of exposure in soil, neither evident earthworm mortalities (< 10 %) nor evident pathological symptoms or changes in the behaviour of adult earthworms were observed in the controls and all test item concentrations. There were no statistically significant differences in earthworm body weights at all test item concentrations compared to the control. After a further four weeks, the reproduction rate (average number of juveniles produced) was 112 in the control and ranged from 34 to 96 in the test item treatment rates. There was no statistically significant difference in earthworm reproduction in the treatment rates 2.81 to 90 mg /kg SDW compared to the control. However, at the test item concentrations 180 and 360 mg/kg SDW the earthworm reproduction was statistically significantly reduced. After 8 weeks, the EC10 (reproduction) of the test item to earthworm (Eisenia fetida) was determined to be 72.1 mg/kg soil dry weight.