6'-(dibutylamino)-3'-methyl-2'-(phenylamino)spiro[isobenzofuran-1(3H),9-(9H)-xanthen]-3-one

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988-10-31 to 1988-11-02

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

1984, Part I

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

GLP compliance:

yes

Analytical monitoring:

yes

Vehicle:

yes

Remarks:

1 % Tween 80

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Preliminary Solution in 1 % Tween 80-tetrahydrofuran. 100 mg test substance was dissolved in auxiliary solvent and the volume made up to 10 mL. 100 µL of this stock solution was added to 1 litre diluent to give the required test concentration.
- Differential loading: 20 mL test solution/organism
- Controls: untreated control, solvent control
- Chemical name of vehicle: organic solvent

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water Flea
- Strain: Daphnia magma STRAUS
- Source: laboratory culture by IRCHA, France
- Feeding during test: Yes
- Food type: fry fish food (Liquifry) and a suspension of mixed algae (predominantly Chlorella spp.)
- Frequency: daily

METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES:
Gravid adults were isolated 24 h prior to test initiation. Young daphnids produced overnight were used for testing.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

350 mg/L (as CaCO3)

Test temperature:

20 ± 2 °C

pH:

8.0

Dissolved oxygen:

8.6 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Jars
- Type: open
- Material, fill volume: glass, 200 mL
- Aeration: None
- Renewal rate of test solution: None
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 2
- No. of vessels per vehicle control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dechlorinated and aged laboratory tap water.

OTHER TEST CONDITIONS
- Photoperiod: light/dark 16/8 h

EFFECT PARAMETERS MEASURED: Mobility

VEHICLE CONTROL PERFORMED: yes

Reference substance (positive control):

no

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

>= 1 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Behavioural abnormalities: None obeserved
- Mortality of control: None

Validity criteria fulfilled:

not specified

Conclusions:

In an acute toxicity test with daphnia magna according to OECD guideline 202 an EC50 of above 1.0 mg/L was observed.

Executive summary:

Acute aquatic toxicity in daphnia was determined according to OECD guideline 202, Part I (Huntingdon, 1989). Daphnia magna were exposed to the test substance for 48 hours. Due to the limited solubility of the test substance in water, 1 mg/L was the highest tested concentration that could be prepared. After 48 treatment, no mortality or impaired mobility was observed in control or treatment group. A 48-hour EC50 value of above 1 mg/L was determined.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

as cited in 84/449/EEC

GLP compliance:

yes

Vehicle:

yes

Details on test solutions:

- Concentration of vehicle in test medium: Dimethylformamide containing 1% Tween 80 was used as an auxiliary solvent at a level of 0.1 g/L

Test organisms (species):

other: Daphnia similis

Hardness:

80 mg CaCO3/L

Key result

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

49 mg/L

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

10 mg/L

Validity criteria fulfilled:

not specified

Conclusions:

In an acute daphnia test an EC50 of 49 mg/L was observed after 24 h.

Executive summary:

Short term aquatic toxicity was determined according to EU method C.2 (NIPPON SODA, ECHA RSS, 2017). Daphnia similis was exposed to the test substance for 24 hours. An EC50 of 49 mg/L was determined.

Description of key information

In the acute toxicity key study with daphnia magna an EC50 above 1.0 mg/L of the test substance was determined.

Additional information

Key study

Acute aquatic toxicity in daphnia was determined according to OECD guideline 202, Part I (Huntingdon, 1989). Daphnia magna were exposed to the test substance for 48 hours. Due to the limited solubility of the test substance in water, 1 mg/L was the highest tested concentration that could be prepared. after 48 -hour treatment, no mortality or impaired mobility was observed in control or treatment group. A 48-hour EC50 value of above 1.00 mg/L was determined.

In accordance with Article 25(3) of the REACH Regulation the robust study summaries submitted 12 years previously, are additionally used for the purpose of the registration.

Supporting study

Short term aquatic toxicity was determined according to EU method C.2 (NIPPON SODA, ECHA RSS, 2017). Daphnia similis was exposed to the test substance for 24 hours. An EC50 of 49 mg/L was determined.