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

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988-10-31 to 1988-11-04

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Sampling method: chemical analysis at 0, 24 and 96 hours.

Vehicle:

yes

Remarks:

1 % Tween-80

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- 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. 4 mL of this stock solution was added to 40 litre diluent to give the required test concentration.
1.0 mg/L was the highest test concentration due to the limited solubility of the test item and the restricted use of auxiliary solvents according to OECD Guideline 203.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: rainbow trout
- Source: Westacre Trout Farm, Norfolk, U.K.
- Length at study initiation ( mean and SD): 4.5 cm, SD = 0.2 cm
- Weight at study initiation (mean and SD): 1.01 g; SD = 0.16 g


ACCLIMATION
- Acclimation period: 8 days
- Acclimation conditions: same as test
- Type and amount of food during acclimation: Commercial trout pellets
- Feeding frequency during acclimation: daily
- Health during acclimation (any mortality observed): < 1 % in 7 days prior to the test.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

350 mg/L (as CaCO3)

Test temperature:

14 ± 1 °C

pH:

8.4

Dissolved oxygen:

9.8 mgO2/L

Nominal and measured concentrations:

nominal: 1 mg/L
measured: 0.96 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Aquaria
- Type: open
- Material, fill volume: Glas, 40 L
- Aeration: Yes, via narrow bore glass tubes.
- Renewal rate of test solution: Daily
- No. of organisms per vessel: 20
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: 0.25 g bw/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Laboratory tap water, dechlorinated by the addition of sodium thiosulphate.
- Total organic carbon: 4.5 mg/L; SD 0.51
- Metals:
Calcium: 133.5 mg/L; SD 0.95
Magnesium: 8.3 mg/L; SD 0.45
Sodium: 43.8 mg/L; SD 4.06
Potassium: 7.75 mg/L; SD 0.29
Iron: 0.0376 mg/L; SD 0.02

- Chlorine: 59.46 mg/L; SD 4.35
- Alkalinity: 215.2; SD 8.95
- Ca/Mg ratio: 16.6
- Period of water quality measurement: 1988-01-01 to 1988-03-31

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: light /dark 16 h/8 h

EFFECT PARAMETERS MEASURED: Mortality

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

not determinable

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Validity criteria fulfilled:

not specified

Conclusions:

A 96-hour LC50 value of above 1.0 mg/L was determined. The NOEC was set to equal or above 1.0 mg/L.

Executive summary:

Acute aquatic toxicity in fish was determined according to OECD guideline 203 (Huntingdon, 1989). Rainbow trout were exposed to the test substance under semi-static conditions for 96 hours. Due to the limited solubility of the test substance in water, 1 mg/L was the highest nominally tested concentration that could be prepared. No mortalities or sublethal effects were observed during the study. A 96-hour LC50 value of above 1.0 mg/L was determined. The NOEC was set to equal or above 1.0 mg/L.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

GLP compliance:

yes

Test organisms (species):

Oryzias latipes

Test type:

static

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Validity criteria fulfilled:

not specified

Conclusions:

In an acute fish test an LC50 >100 mg/L was observed after 96 h.

Executive summary:

Short term aquatic toxicity was determined according to EU method C.1 (NIPPON SODA, ECHA RSS, 2017). Oryzia latipes was exposed to the test substance for 96 hours under static conditions. No effects were observed up to 100 mg/L (nominal). An LC50 of above 100 mg/L was determined.

Description of key information

In the acute toxicity key study with fish (Oncorhynchus mykiss) an LC50 of above1 mg/L was determined for the test substance.

Additional information

Key study

Acute aquatic toxicity in fish was determined according to OECD guideline 203 (Huntingdon, 1989). Rainbow trout were exposed to the test substance under semi-static conditions for 96 hours. Due to the limited solubility of the test substance in water, 1 mg/L was the highest nominally tested concentration that could be prepared. No mortalities or sublethal effects were observed during the study. A 96-hour LC50 value of above 1.0 mg/L was determined. The NOEC was set to equal or above 1.0 mg/L.

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.1 (NIPPON SODA, ECHA RSS, 2017). Oryzia latipes was exposed to the test substance for 96 hours under static conditions. No effects were observed up to 100 mg/L (nominal). An LC50 of above 100 mg/L was determined.