4-isopropylcyclohexanol

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:

Study completion Date 15 May 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

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:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4-isopropylcyclohexanol

EC Number:

225-035-0

EC Name:

4-isopropylcyclohexanol

Cas Number:

4621-04-9

Molecular formula:

C9H18O

IUPAC Name:

4-(propan-2-yl)cyclohexan-1-ol

Test material form:

liquid

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

For the determination of the appropriate test concentrations for the main test, a range-finding test was performed. The nominal test item concentrations tested were 1.0, 10 and 100 mg/L. For this, two replicates per treatment were tested under identical exposure conditions than those applied for the main test. The test medium of the highest concentration of 100 mg/L was stirred until dissolution for 10 minutes at room temperature. The test media of the two lower concentrations were prepared in a series of further dilution steps.

Test solutions

Vehicle:

no

Details on test solutions:

Based on the range-finder results the following nominal concentrations of FOLROSIA were selected for the main test: 4.6, 10, 22, 46 and 100 mg/L. Additionally, a control (test water without test item) was tested in parallel. For each treatment, 20 daphnids were randomly distributed into four replicates of five daphnids each. The volume of test medium provided for each daphnid was 10 mL (50 mL per replicate). Thus, the requirement of the test guidelines for a minimum volume of 2 mL test medium per daphnid was fulfilled.

The measured concentrations of the test item FOLROSIA in the test media of the nominal test concentrations of 4.6 to 100 mg/L were between 102 and 114% of the nominal values at the start of the test. Thus, the correct dosage of the test item could be verified. At the end of the test, 69 to 93% of the nominal values were found. The mean measured exposure concentration (geometric mean of Time 0 and 48 hour analyses) was 4.5, 9.4, 21, 43 and 86 mg/L, respectively, at the 4.6, 10, 22, 46 and 100 mg/L (nominal) test concentrations.

Test organisms

Test organisms (species):

Daphnia magna

Study design

Test type:

static

Water media type:

other: Reconstituted test water according to ISO 6341

Limit test:

no

Total exposure duration:

48 h

Test conditions

Hardness:

250 mg/L as CaCO3

Test temperature:

The test was performed in a temperature-controlled room with continuous monitoring of the room temperature. The water temperature was in the range of 20-21 °C.

pH:

pH in the range of 7.6 to 7.8.

Dissolved oxygen:

Dissolved O2 was > or = 8.2 mg/L.

Nominal and measured concentrations:

The mean measured exposure concentration (geometric mean of Time 0 and 48 hour analyses) was 4.5, 9.4, 21, 43 and 86 mg/L, respectively, at the 4.6, 10, 22, 46 and 100 mg/L (nominal) test concentrations.

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

42 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% CI : 35 - 50 mg/L

Effect concentrations 2

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

9.4 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

other: Series of sub-lethal effects observations (e.g. but not limited to discolouration, swimming behaviour)

Effect concentrations 3

Duration:

48 h

Dose descriptor:

EC0

Effect conc.:

9.4 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 4

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

86 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

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 October 2016 (24-hour EC50: 1.0 mg/L, IES Laboratories Study 20160278) showed that the sensitivity of the test organisms was within the range given by the guideline (24-hour EC50: 0.60 2.1 mg/L).

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Executive summary:

A clear dose-response effect was observed during the study. The test item FOLROSIA had acute toxic effects on Daphnia magna in a 48-hour static test.

The biological results were based on the geometric mean measured concentrations:

EC50 (48 hr): 42 (95% CI : 35 - 50) mg/L

EC0 (48 hr): 9.4 mg/L

EC100 (48 hr): 86 mg/L

NOEC (48 hr) : 9.4 mg/L