Distillate of tobacco leaf, Nicotiana tabacum, solanaceae

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:

Oct. 12-Nov. 30, 2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Distillate of tobacco leaf, Nicotiana tabacum, solanaceae

EC Number:

953-863-9

IUPAC Name:

Distillate of tobacco leaf, Nicotiana tabacum, solanaceae

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: All concentrations
- Sampling method: before and after media renewal, test end
- Sample storage conditions before analysis: If not measured on day of sampling, samples were stored at -18 degrees C.

Test solutions

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 99.3 uL of test item was transferred to a glass flask and filled with 1000 mL dilution water. This was stirred for 15-30 minutes.
- Other relevant information: Cu-reduced dilution water enriched with CaCl2.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Age at study initiation (mean and range, SD): 4-24 hrs old
- Source: German Federal Environment Agency, Institut fur Wasser-, Boden-, und Lufthygiene
- Age of parental stock (mean and range, SD): At least 3 weeks
- Feeding during test: No

Study design

Test type:

semi-static

Water media type:

other: Cu-reduced dilution water enriched with CaCl2.

Limit test:

no

Total exposure duration:

48 h

Test conditions

Hardness:

250-350 mg CaCO3/L

Test temperature:

19.0-19.5 degrees C

pH:

7.78-8.31

Dissolved oxygen:

7.88-8.85 mg/L

Nominal and measured concentrations:

Nominal: 6.25, 12.5, 25.0, 50.0, and 100 mg/L
Active ingredient (nicotine): 1.39, 2.78, 5.55, 11.1, and 22.2 mg/L
Geometric mean measured: 0.944, 1.91, 3.71, 7.49, and 15.1 mg a.s./L

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open, but covered with glass
- Material, size, headspace, fill volume: 50 mL glass beakers
- Volume of solution: 50 mL
- Aeration: yes, open to atmosphere
- Renewal rate of test solution (frequency/flow rate): Renewed at 24 hrs
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Total organic carbon: 0.929 mg/L
- Metals: < 4.053 ug/L
- Chlorine: <0.02 mg/L
- Alkalinity: 1.8 mmol/L
- Ca/mg ratio: 0.9/0.3
- Conductivity: 283 uS/cm


OTHER TEST CONDITIONS
- Photoperiod: 16 hrs light/8 hrs dark
- Light intensity: 698-779 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mobility, appearance and behaviour, daily

RANGE-FINDING STUDY
- Test concentrations: 1.0, 10, and 100 mg test item/L
- Results used to determine the conditions for the definitive study: yes

Reference substance (positive control):

yes

Remarks:

Sensitivity of test organisms is tested twice per year using K2Cr2O7.

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

1.91 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

act. ingr.

Basis for effect:

mobility

Effect concentrations 2

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

3.84 mg/L

95% CI:

2.79 - 5.3

Nominal / measured:

meas. (geom. mean)

Conc. based on:

act. ingr.

Basis for effect:

mobility

Details on results:

- Behavioural abnormalities: yes, daphnids at the 1.91 mg a.s./L concentration were less active than animals in the 0.944 mg a.s./L and control concentrations at 24 and 48 hrs. At higher concentrations, living daphnids were observed on the ground with little movement and twitching.

Any other information on results incl. tables

One daphnid was immobilized in the test medium control.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The 48-hr EC50 for Daphnia magna is 3.84 mg/L.

Executive summary:

The toxicity of the dossier substance was determined in an OECD guideline 202 test.  Concentrations of 0, 6.25, 12.5, 25.0, 50.0, and 100 mg/L (nominal) were tested.  Concentrations of the nicotine in the test substance were measured giving the following concentrations based on the geometric mean 0.944, 1.91, 3.71, 7.49, and 15.1 mg a.s./L.  The 48-hr EC50 for Daphnia magna is 3.84 mg/L.