Reaction products of 1,4-cyclohexanedimethanol with propylene oxide and ammonia

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:

2012-07-30 - 2012-08-20

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:

no

Details on sampling:

- Concentrations: 10, 18, 32, 56, 100 mg/L
- Sample storage conditions before analysis: The 0 and 24 hour samples were stored at approximately -20 °C prior to analysis. The 96 hour
samples were analyzed on the day of receipt.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test item was dissolved directly in dechlorinated tap water. Amounts of test item (200, 360, 640, 1120 and 2000 mg) were weighed out and each added separately to 20 liters of dechlorinated tap water to give the 10, 18, 32, 56 and 100 mg/L test concentrations. Once the test item had been added to the dechlorinated tap water the water was mixed vigorously using a flat-bladed mixer for approximately 1 minute to ensure homogeneity.
- Controls: negative control
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): not applicable
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: rainbow trout
- Source: Brow Well Fisheries Limited, Hebden, near Skipton, Yorkshire, UK
- Length at study initiation (length definition, mean, range and SD): 4.8 cm (sd = 0.1)
- Weight at study initiation (mean and range, SD): 1.51 g (sd = 0.27)
- Feeding during test: no

ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions (same as test or not): water conditions similar (tap water, not chlorinated, passed through an active carbon filter, aerated with oil-free air) but flow through conditions were used
- Type and amount of food: The stock fish were fed commercial trout pellets which was discontinued approximately 24 hours prior to the start of the
definitive test.
- Feeding frequency: daily
- Health during acclimation (any mortality observed): 0% during the last 2 weeks

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

total hardness: 140 mg/L as CaCO3

Test temperature:

14 °C (temperature-controlled room)

pH:

7.0 to 7.9

Dissolved oxygen:

9.0 mg/L

Salinity:

not applicable

Nominal and measured concentrations:

nominal: 0 (control), 10, 18, 32, 56 and 100 mg/L.

Details on test conditions:

TEST SYSTEM
- Test vessel: glass fiber tank with a single pass water renewal system
- Type (delete if not applicable): covered to reduce evaporation
- Material, size, headspace, fill volume: 20 L glass vessel
- Aeration: yes
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Laboratory tap water was dechlorinated by passage through an activated carbon filter (Purite
Series 500) and partly softened (Elga Nimbus 1248D Duplex Water Softener)
- Total hardness: 140 mg/L
- pH: about 7.0 to 7.9
- Temperature: 14°C
- Oxygen: 9.0 mg/L O2/L

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light: 8 hours dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- mortality and symptoms: after 3, 6, 24, 48, 72, and 96 h
- pH, oxygen, and temperature: after 3, 6, 24, 48, 72, and 96 h
- chemical analysis: after 0, 24 and 96 h

TEST CONCENTRATIONS
- Spacing factor for test concentrations: approximately 1.8
- Range finding study
- Test concentrations: 1.0, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: yes. Test concentrations definitive study: 10, 18, 32, 56 and 100 mg/L

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

75 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 56 - 100 mg/L

Details on results:

- Behavioural abnormalities: see "Any other information on results incl. tables"
- Mortality of control: 0%
- Other adverse effects control: no
- Abnormal responses: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: no

Sublethal observations / clinical signs:

Mortality

The results of the definitive test showed the highest test concentration resulting in 0% mortality to be 56 mg/L, the lowest test concentration resulting in 100% mortality to be 100 mg/L. The Lowest Observed Effect Concentration (LOEC) was considered to be 100 mg/L. The No

Observed Effect Concentration (NOEC) was 56 mg/L.

Sub-lethal effects

Sub-lethal effects of exposure were observed at test concentrations of 56 mg/L and above. These responses were increased pigmentation and swimming at the base of the vessel. After approximately 24 hours exposure 1 out of 1 fish at 100 mg/L was observed to be moribund.

Conclusions:

In this study, the acute toxicity of Jeffamine RFD 270 to rainbow trout was investigated in a 96-h static study (nominal concentrations of 18, 32, 56, and 100 mg/L). The 96-h LC50 was 75 mg/L with 95% confidence limits of 56-100 mg/L.

Description of key information

The acute toxicity of the test substance to rainbow trout was investigated in a 96-h semi-static study (nominal concentrations of 18, 32, 56, and 100 mg/L). Sub-lethal effects of exposure were observed at test concentrations of 56 mg/L and above. These responses were increased pigmentation and swimming at the base of the vessel. After approximately 24 hours exposure, 100% of the tested fish at 100 mg/L was observed to be moribund. The 96-h LC50 was 75 mg/L with 95% confidence limits of 56-100 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

75 mg/L

Additional information

The acute fish study of Parr (2012) was used as key study for PNEC derivation. Rainbow trout were exposed to the test substance during 96 hours in a semi-static test. The 96-h test was conducted according to OECD guideline 203. The nominal test concentrations were: 0, 18, 32, 56 and 100 mg/L.

Since the analytically determined concentrations were within +/- 20% of the nominal concentrations, the results can be based on nominal concentrations. A 96-h LC50 of 75 mg/L for rainbow trout was obtained in this study. This indicates that the test substance is harmful to fish.