Distillate of tobacco leaf, Nicotiana tabacum, solanaceae

Toxicity to aquatic algae and cyanobacteria

Administrative data

Endpoint:

toxicity to aquatic algae and cyanobacteria

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 201 (Alga, Growth Inhibition 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 addition of algae, 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 minutes.

Test organisms

Test organisms (species):

Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)

Details on test organisms:

TEST ORGANISM
- Strain: Catalog No 61.81 SAG
- Source (laboratory, culture collection): SAG, Culture Collection of Algae at Pflanzenphysiologisches Institut of the University at Göttingen, Albrecht von Haller Institut, Untere Klarspüle 2, 37073 Göttingen
- Age of inoculum (at test initiation):
- Method of cultivation: According to OECD guideline

ACCLIMATION
- Acclimation period: 3 days

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

72 h

Test conditions

Test temperature:

22 degrees C

pH:

7.42-8.38

Nominal and measured concentrations:

Nominal: 0, 6.25, 12.5, 25.0, 50.0 and 100 mg test item/L
Measured: 0, 0.40, 1.53, 3.75, 7.73 and 15.7 mg a.s./L

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open, air-permeable silicone-sponge caps
- Material, size, headspace, fill volume: 250 mL glass, 100 mL
- Initial cells density: 10,000 cells/mL
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 8


GROWTH MEDIUM
- Standard medium used: yes


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: purified water


OTHER TEST CONDITIONS
- Light intensity and quality: 4440-8880 lux


EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
- Determination of cell concentrations: electronic particle counter, every 24 hrs


TEST CONCENTRATIONS
- Test concentrations: 1.0, 10.0, and 100 mg/L

Reference substance (positive control):

yes

Remarks:

3,5-dichlorophenol, tested twice per year

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

7.73 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

act. ingr.

Basis for effect:

yield

Effect concentrations 2

Key result

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

13.7 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

act. ingr.

Basis for effect:

growth rate

Details on results:

- Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test): At the highest concentration, only a few algal cells were observed.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The 72 hr ECr50 for tobacco distillates is 13.7 mg a.s.(nicotine)/L.

Executive summary:

The toxicity of the dossier substance to freshwater algae was determined in an OECD Guideline 201 study.  Concentrations of 0, 6.25, 12.5, 25.0, 50.0 and 100 mg test item/L (nominal) were tested.  Measured values based on concentration of nicotine were determined to be 0, 0.40, 1.53, 3.75, 7.73 and 15.7 mg a.s./L (geometric mean).  The 72 hr ECr50 for tobacco distillates is 13.7 mg a.s.(nicotine)/L.  The 72-hr NOEC based on growth rate was 7.73 mg a.s./L.