2,2,2',2'-tetrakis(hydroxymethyl)-3,3'-oxydipropan-1-ol

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

Study period:

30 December 1991 - 03 January 1992.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 10, 18, 32, 56 and 100 mg/L
- Sampling method: duplicate water samples were taken
- Sample storage conditions before analysis: samples stored at -20°C until analysis by Sponsor.

Vehicle:

no

Details on test solutions:

Prepared by direct dispersion in water with the aid of ultrasonic disruption.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: Rainbow trout
- Strain:
- Source: Westacre Trout Farm, Norfolk, U.K.
- Age at study initiation (mean and range, SD):
- Length at study initiation (length definition, mean, range and SD4.8 cm (SD=0.5):
- Weight at study initiation (mean and range, SD): 1.99 g (SD=0.45)
- Method of breeding:
- Feeding during test
- Food type: commercial trout pellets
- Amount:
- Frequency: discontinued 24 hours prior to test


ACCLIMATION
- Acclimation period: 1 month (20 November 1991 - 30 December 1991).
- Acclimation conditions (same as test or not): Yes
- Type and amount of food:
- Feeding frequency:
- Health during acclimation (any mortality observed): 0% mortality 7 days prior to study

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

Not applicable

Hardness:

150-200 mg/L as CaCO3

Test temperature:

14 °C

pH:

7.1 - 7.2

Dissolved oxygen:

10.1 - 10.2 mgO2/L

Salinity:

not applicable

Nominal and measured concentrations:

Nominal: 10, 18, 32, 56 and 100 mg/L. Measured: 9.5, 17, 30, 53 and 93 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open / closed
- Material, size, headspace, fill volume: glass, 20 litres
- Aeration: via narrow bore glass tubes
- Renewal rate of test solution : daily renewal
- No. of organisms per vessel:10
- No. of vessels per concentration (replicates):1
- No. of vessels per control (replicates):1
- Biomass loading rate: fish were placed in prepared test media at 1.0 g bodyweight/litre

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: laboratory tap water, dechlorinated by passage through activated carbon and softened by reserved osmosis.


OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod:16 h light: 8 h dark
- Light intensity:


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Death is absence of i) respiratory movement and ii) response to physical stimulation

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

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:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: As teh assessed endpoint is mortality, pigment changes seen at 56 mg/L are not deemed relevant for NOEC determination.

Details on results:

- Behavioural abnormalities: none reported
- Observations on body length and weight: none reported
- Other biological observations: increased pigmentation in two of ten fish at the highest dose level
- Mortality of control:none

Results with reference substance (positive control):

Not applicable

Reported statistics and error estimates:

Not applicable

Validity criteria fulfilled:

yes

Conclusions:

Rainbow trout were exposed to nominal exposure concentrations of 0, 10, 18, 32, 56 and 100 mg/L dipentaerythritol for 96 hours under semi-static conditions. Mean measured concentrations indicated that the test media had been adequately prepared and were within +/- 20%, therefore the results of the study are based on nominal exposure concentrations. No mortality was observed in any of the test concentrations, therefore, the 96 hr LC50 >100 mg/L. As no sublethal effects were observed and the observed endpoint was mortality, the no-observed effect concentration (NOEC) was observed to be 100 mg/L.

Executive summary:

In a 96-h acute toxicity study, rainbow trout (Oncorhynchus mykiss) were exposed to nominal exposure concentrations of 0, 10, 18, 32, 56 and 100 mg/L dipentaerythritol under semi-static conditions (daily renewal).  The concentration of dipentaerythritol was verified analytically and was prepared by direct dispersion in water with the aid of ultrasonic disruption. Mean measured concentrations indicated that the test media had been adequately prepared and were within +/- 20%, therefore the results of the study are based on nominal exposure concentrations.  Increased pigmentation in two of ten fish at the highest dose level was observed. No mortality was observed in any of the test concentrations, therefore, the 96 hr LC50 >100 mg/L. As no sublethal effects were observed and the observed endpoint was mortality, the no-observed effect concentration (NOEC) was observed to be 100 mg/L.

 

This toxicity study is classified as acceptable and satisfies the guideline requirements for OECD 203 acute fish toxicity studies. Based on the results of this study, dipentaerythritol does not need to be classified in regards to environmental hazards according to Regulation (EC) No 1272/2008 (Part 4) and Directive 67/548/EEC

 

Results synopsis

Test organism size/age: unknown, 4.8 cm (SD=0.5)

Test type: Semi-Static (daily renewal)

LC50: > 100 mg/L

NOEC: 100mg/L

Endpoint(s) effected: Mortality

Description of key information

Rainbow trout were exposed to nominal exposure concentrations of 0, 10, 18, 32, 56 and 100 mg/L dipentaerythritol for 96 hours under semi-static conditions. Mean measured concentrations indicated that the test media had been adequately prepared and were within +/- 20%, therefore the results of the study are based on nominal exposure concentrations. No mortality was observed in any of the test concentrations, therefore, the 96 hr LC50 >100 mg/L. As no sublethal effects were observed and the observed endpoint was mortality, the no-observed effect concentration (NOEC) was observed to be 100 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

> 100 mg/L