Reaction mass of 1,2,2,6,6-pentamethylpiperidin-4-yl hexadecanoate and 1,2,2,6,6-pentamethylpiperidin-4-yl octadecanoate

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 August 2012 to 24 January 2013

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 1,2,2,6,6-pentamethylpiperidin-4-yl hexadecanoate and 1,2,2,6,6-pentamethylpiperidin-4-yl octadecanoate

EC Number:

700-792-4

Molecular formula:

C26H51NO2, C28H55NO2

IUPAC Name:

Reaction mass of 1,2,2,6,6-pentamethylpiperidin-4-yl hexadecanoate and 1,2,2,6,6-pentamethylpiperidin-4-yl octadecanoate

Test material form:

other: SOLID

Details on test material:

- Name of test material (as cited in study report): T-1640L

- Physical state: solid
- Analytical purity: 98.74%
- Impurities (identity and concentrations): 2 known impurities, impurity 1 = 0.3%, impurity = 0.4%. Unknown impurities = 0.6%
- Composition of test material, percentage of components: 7 components = 98.74% in total
- Isomers composition:N/A
- Purity test date:20 May 2011
- Lot/batch No.: 10121
- Expiration date of the lot/batch: 18 October 2013

- Stability under test conditions: stable
- Storage condition of test material: Refrigerated in the dark
- Other:

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: WAF's with nominal loading rates of 4.27, 9.39, 20.7, 45.5 and 100 mg/L
- Sampling method: Two samples of media were taken from the control and test vessels at 0 and 72 hours (fresh media) and at 24 and 96 hours (expired media) for analysis.
- Sample storage conditions before analysis: One sample (from each pair of samples) was analysed straight away and one was stored in a freezer at ca. -20C in case further analysis was required.

Test solutions

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Aliquots of the test substance (nominally 93.9, 206.6, 455.4, 1001 or 2200 mg) were weighed
into aspirators containing dilution water (22 L). The aspirators were covered, stirred
overnight, and then left to stand overnight after which ca. 20 L were syphoned from the midvessel
of each vessel to provide Water Accommodated Fractions (WAFs) with nominal
loading rates of 4.27, 9.39, 20.7, 45.5, and 100 mg/L.
In the definitive test, seven fish were placed at random into each glass aquarium containing
the prepared control or test media. Each vessel contained ca. 20 litres of medium to a depth
of 19 cm. This provided an initial static loading of 0.585 g bodyweight/Litre.

Test organisms

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: Rainbow trout
- Strain: N/a
- Source:Fertilised eggs supplied by a commercial fish fam in the UK and hatched at Huntingdon Life Sciences
- Age at study initiation (mean and range, SD): 12 weeks
- Length at study initiation (length definition, mean, range and SD): - 5.66 cm
- Weight at study initiation (mean and range, SD): 1.671g
- Method of breeding:
- Feeding during test: No food given during 24h before exposure and also none given during the exposure period
- Food type:Commercial fish food (TROUW (UK) Ltd. prior to exposure
- Amount: 1-4% of the total wet-weight of fish in the holding tank
- Frequency: Daily

ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: 1-4% of wet weight
- Feeding frequency: daily
- Health during acclimation (any mortality observed): none

QUARANTINE (wild caught)
- Duration: N/A
- Health/mortality: N/A

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

N/a

Test conditions

Hardness:

171 - 211 mg/L CaCO3 (maximum permissable value 200 mg/L

Test temperature:

12 - 17C

pH:

7.39 - 8.22

Dissolved oxygen:

95 - 96% ASV

Salinity:

N/a

Nominal and measured concentrations:

WAF's with nominal loading rates of 4.27, 9.39, 20.7, 45.5 and 100 mg/L were employed in the definitive test. Measured mean levels from study samples were 0.0412, 0.0809, 0.489, 0.963 and 3.40 mg/L.

Details on test conditions:

TEST SYSTEM
- Test vessel: glass aquaria
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume:Each vessel contained ca. 20 litres of medium to a depth of 19 cm
- Aeration: Supplementary aeration was provided via narrow bore glass tubes
- Type of flow-through (e.g. peristaltic or proportional diluter): N/a
- Renewal rate of test solution (frequency/flow rate): daily batch renewal of the media
- No. of organisms per vessel: 7 fish per vessel
- No. of vessels per concentration (replicates):1
- No. of vessels per control (replicates):1
- No. of vessels per vehicle control (replicates):
- Biomass loading rate:0.585 g bwt/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: The water used to hold the fish and for the study was laboratory tap water, dechlorinated and softened by passage through a water purification system. It was passed through a high grade activated carbon filter to remove chlorine and any organic contaminants. A proportion of the supply then passed through a water softener before final reverse osmosis treatment to produce a highly purified water supply. The two grades of dechlorinated water were then remixed to give a supply with the desired water hardness.
- Total organic carbon: 0.55 mg/L
- Particulate matter: <2.0 mg/L
- Metals:
- Pesticides:<3.30 mg/L
- Chlorine:18.7 mg/L
- Alkalinity:
- Ca/mg ratio: ca 17
- Conductivity: 341 uS/cm
- Culture medium different from test medium:
- Intervals of water quality measurement:

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

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS
- Spacing factor for test concentrations: not more than 2.2
- Justification for using less concentrations than requested by guideline:
- Range finding study
- Test concentrations: nominal loading rates of 10.0 and 100 mg/L
- Results used to determine the conditions for the definitive study: deaths from range finding study

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 3.4 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

96 h

Dose descriptor:

NOELR

Effect conc.:

9.39 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 3

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

0.081 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities:
- Observations on body length and weight: None
- Other biological observations: darkended pigmentation of the body and/or the eye orbital area, lethargy and immobility
- Mortality of control: None
- Other adverse effects control: None
- Abnormal responses:
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: Measurable levels of T-1640L were found in the control samples, however the mean value was one order of magnitude below the NOEC for the study
- Effect concentrations exceeding solubility of substance in test medium: None

Results with reference substance (positive control):

N/a

Reported statistics and error estimates:

N/a

Applicant's summary and conclusion

Conclusions:

T-1640L was not found to be acutely toxic to rainbow trout (Oncorhynchus mykiss). Water
accommodated fractions of T-1640L were used, and based on nominal loading rates, the 96
hour LL50 must be >100 mg/L the maximum loading rate tested or a mean measured
concentration of >3.40 mg/L (LC50).
Based on nominal concentrations, the no observed effect loading rate (NOELR) was
9.39 mg/L and the no-observed effect concentration (NOEC) was 0.0809 mg/L as mean
measured concentrations.