Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled, oligomerisation products with 1-chloro-2,3-epoxypropane

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 100 mg/L
- Sample storage conditions before analysis: no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The water-accommodated fractions were prepared for the test. This was done by weighing of the respective load 100.1 mg/L adding the corresponding amount of tap water and stirring on a magnetic stirrer slowly for 24 hours. The lower phase of resulting solution was used unfiltered as test solution.
- Eluate: N.a.
- Differential loading: N.a.
- Controls: Blank control
- Chemical name of vehicle: no vehicle used
- Evidence of undissolved material: No

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish (Danio rerio)
- Strain: N.a.
- Source: Umweltbundesamt (UBA), Germany
- Age at study initiation (mean and range, SD): Sexually immature young fish
- Length at study initiation (length definition, mean, range and SD): 2 ± 1 cm
- Feeding during test: No
- Food type: Warmwater fish food and daphnia (in the pre-test holding phase)
- Amount: Totalling to about 1-2 % of body weight/day (in the pre-test holding phase)
- Frequency: Three times a day (in the pre-test holding phase)

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

None

Test temperature:

22.6 - 24.2 °C

pH:

8.0 - 8.6

Dissolved oxygen:

> 8.1 mg/L or 92 %

Nominal and measured concentrations:

Nominal: 100.1 mg/L
At the beginning and at the end of the test, the content of the test item in the test solutions was determined using DOC-determination. Because of the very low solubility in test medium, no calculation from content of carbon of the test item and DOC measurement was possible.

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass aquaria
- Material, size, headspace, fill volume: Maximal volume 10 L
- Aeration: None
- No. of organisms per vessel: 1 fish/L
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

OTHER TEST CONDITIONS
- Adjustment of pH: None
- Photoperiod: 12/12 hours using neon tubes

TEST CONCENTRATIONS
100.1 mg/L nominal

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOELR

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: No abnormal behaviour of the surviving fish was observed

Validity criteria fulfilled:

yes

Conclusions:

In a GLP study according to OECD Test Guideline 201, the registered substance was tested with a nominal concentration of 100.1 mg/L. No mortatlity was observed, so that the 96h-NOELR was >= 100 mg/L and the 96-h LL50 was > 100 mg/L.

Executive summary:

The toxicity of the registered substance against Danio rerio was tested using a static test design.

Two experiments were performed.

The first experiment was performed as a limit test using the test item concentration of 100 mg/L. Therefore the test solution was prepared by weighting the load of 100.1 mg/L, adding the corresponding amount of dilution water and shaking vigorously for 24 hours. The resulting solution was filtrated through 0.45 µm filters. After 24 hours two fishes in the blank control and all fishes in the treatment were dead. As undissolved test item was observed in the treatment a study plan amendment was issued for different preparation of the test solutions and the experiment was repeated. The results of this experiment are not mentioned in this report, but all raw data will be stored according GLP regulations.

In the second experiment all validity criteria were met.

The second experiment was performed as a limit test using the test item concentration of 100.1 mg/L. No mortality was observed in the control and in the treatments.

At the beginning and at the end of the test, the content of the test item in the test solutions was determined using DOC-determination. Because of the very low solubility in test medium, no calculation from content of carbon of the test item and DOC measurement was possible. The measured start concentration in the treatment was only slightly above the LOQ. At the end of the test, the concentration of DOC in the treatment and the control was in the same range. That means that in presence of the test organism, the DOC was affected by the animals. Therefore, the determination of the biological results was based on the nominal loadings.

The following results for the test item CARDOLITE NC-513 could be determined:

96h NOELR ≥ 100 mg/L

96h LL50 > 100 mg/L

Description of key information

(96 h) LL50 for freshwater fish (Danio rerio): >100 mg/l [test mat. (nominal), based on: mortality; OECD 203; GLP]

supporting information: (96 h) LL50for freshwater fish (Danio rerio): >1000 mg/l [OECD 203; test mat. (WAFs) (nominal) based on: mortality]

Additional information

In a GLP study according to OECD Test Guideline 201, the registered substance was tested with a nominal concentration of 100.1 mg/L. No mortatlity was observed, so that the 96h-NOELR was >= 100 mg/L and the 96-h LL50 was > 100 mg/L. In conclusion, the registered substance is not acutely toxic to fish up to its maximum water solubility.