Butanedioic acid, 2-hydroxy-, 1,4-bis[5,7,7-trimethyl-2-(1,3,3-trimethylbutyl)octyl] ester

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,4-bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] 2-hydroxybutanedioate

EC Number:

807-422-1

Cas Number:

66918-01-2

Molecular formula:

C40H78O5

IUPAC Name:

1,4-bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] 2-hydroxybutanedioate

Details on test material:

- Name of test material (as cited in study report): SALACOS 222
- Physical state: liquid
- Analytical purity: > 98%
- Lot/batch No.: 7-2-D
- Expiration date of the lot/batch: 04/10
- Stability under test conditions: stable under storage conditions
- Storage condition of test material: room temperature (20 +/- 0.5 °C), light protected

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations:
- Sampling method: sample were taken from the center of the aquaria without mixing; duplicate samples from control and test medium at 0, 48, and 96h
- Sample storage conditions before analysis: deep-frozen and light protected until analysis was performed

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebra fish (Brachydanio rerio)
- Source: RCC Laboratories
- Length at study initiation (length definition, mean, range and SD): 3.0 +/- 0.08 cm
- Weight at study initiation (mean and range, SD): 0.22 +/- 0.02 g
- Feeding during test: no

ACCLIMATION
- Acclimation period: 1 wk
- Acclimation conditions (same as test or not): yes
- Type and amount of food: TetraMin (TETRA Werke, Melle, DE)
- Health during acclimation (any mortality observed): during last two weeks prior to the test no fish died

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

1.25 mmol/L

Test temperature:

22 °C

pH:

control: 7.4; test medium: 7.3

Dissolved oxygen:

control: 7.9-8.2 mg/L; test medium: 7.9-8.1 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 5L glass aquarium
- Aeration: prior to test until oxygen saturation was reached; slight aeration during test period
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates):1
- No. of vessels per control (replicates):1
- Biomass loading rate: 1 g fish wet weight/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
- Total organic carbon:
- Particulate matter:
- Metals:
- Pesticides:
- Chlorine:
- Alkalinity: 0.4 mmol/L
- Ca/mg ratio: 4:1
- Conductivity:
- Culture medium different from test medium:
- Intervals of water quality measurement:

OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod:
- Light intensity:

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS
- Spacing factor for test concentrations:
- Justification for using less concentrations than requested by guideline:
- Range finding study
- Test concentrations:
- Results used to determine the conditions for the definitive study:

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

> 100 mg/L

Basis for effect:

behaviour

Effect concentrations 2

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

> 100 mg/L

Basis for effect:

mortality (fish)

Any other information on results incl. tables

Sublethal observations / clinical signs:

A limit test was performed in accordance with the test guidelines to demonstrate that water accomodated fractions (WAFs) of the test item have no toxic effect on test fish up to the loading rate of 100 mg/L. Thus, the only treatment tested was a WAF with the loading rate of 100 mg/L in parallel to a control.

In the control and the test medium no mortality or other visible abnormalities were determined at the test fish during the test period of 96 hours.

Therefore, the 96 -hour NOEC, and the LC0 (96h) of SALACOS 222 were determined to be at least at the loading rate of 100 mg/L. The LOEC, LC100 and the LC50 at the observation times could not be qualified due to the absence of a toxic effect of the test item at the tested concentration.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The 96-hours NOEC of the test item can be assumed to be higher than 100 mg/L