Poly(oxy-1,2-ethanediyl), α-[2-(dide- cylmethylammonio)ethyl]- .omega.- hydroxy-, propanoate (salt) (Bardap 26)

Long-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

fish early-life stage toxicity

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14/07/2000- 18/12/2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)

Deviations:

no

Principles of method if other than guideline:

Not applicable.

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

Samples to determine the concentration of test substance were taken weekly from each solution of the flow-through system. Temperature was measured continuously until day 26, then three times per week until day 34. pH and oxygen concentration were measured weekly.

Vehicle:

no

Details on test solutions:

Six concentrations of the test subject were used in this study. DSWL-E was used as a control. Stock solutions were created by mixing appropriate amounts of the labelled and unlabelled test substance with ultrapure water. The ratio of labelled to unlabelled was 15%/85% in the 1.0, 3.2, 10 and 32 µg/l test solutions, and 1.5%/98.5% in the 100 and 320 µg/l test solutions. New stock solutions were prepared weekly and stored in a refrigerator until use. The dosed volume of stock solution was approximately 0.1 ml per litre of dilution water.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

-Test organism: Zebra fish (Brachydanio rerio)
- Source: Atlanta fish hatchery, Hellevoetsluis, Netherlands
- Feeding during test
- Food type: Rotifers and Artemi nauplii
- Amount: Fed in abundance.
- Frequency: Rotifers immediately after hatching and Artemi nauplii after 10 days.

Test type:

other: intermittent flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

34 d

Post exposure observation period:

Observations were made daily until all eggs had hatched, then every three days.

Hardness:

Total hardness 238 mg/l as CaCO3

Test temperature:

23.4 to 25.5°C

pH:

7.7 - 8.2

Dissolved oxygen:

Lowest measured oxygen concentration 6.7 mg/L.

Salinity:

No information provided.

Nominal and measured concentrations:

0, 1.0, 3.2, 10, 32, 100 and 320 µg/l
Average measured values were above 100% of nominal values.

Details on test conditions:

The intermittent flow-through system was constructed according to Van Leeuwen et al. Fish were confined to 4 chambers each of volume ca. 272 ml.
4 replicates of 20 eggs/larvae were dosed per concentration. Test substance concentrations were 0, 1.0, 3.2, 10 and 32 µg/l (15:85 % labelled:non-labelled) and 100 and 320 µg/l (1.5:98.5% labelled:non-labelled). Each replicate compartment was supplied with ca. 250 ml newly prepared dose solution every 51 minutes.

Reference substance (positive control):

not specified

Key result

Duration:

34 d

Dose descriptor:

LC50

Effect conc.:

81 µg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

other: Hatching, mortality, morphological and behavioural development, body weight and body length

Remarks on result:

other: 70 – 93µg/l

Duration:

34 d

Dose descriptor:

NOEC

Effect conc.:

32 µg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

other: Hatching, mortality, morphological and behavioural development, body weight and body length

Duration:

34 d

Dose descriptor:

LOEC

Effect conc.:

100 µg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

other: Hatching, mortality, morphological and behavioural development, body weight and body length

Details on results:

The test substance had no effect on hatching. All fish died at a test substance concentration of 320 µg/L. At 100 µg/l fish were observed swimming on the surface. No other observations were made at any other test substance concentrations. No morphological observations were made. The test substance had no effect on body lengths. Body weights appeared to increase at 100 µg/l. The NOEC calculated from the data was 32 µg/l, the 34day LC50 was 81 µg/l and the LOEC was 100 µg/l.

Results with reference substance (positive control):

No information provided.

Reported statistics and error estimates:

The LC50 values and their interval values wee calculated by means of a parametric model. Statistical significance for mortality was determined with a binomial test at 95% significance level, combining the results of the quadruplicates. Statistical significance for growth was determined with the two-tailed Dunnett-test with a 95% and 99% significance level.

Table 1. Actual test substance concentration (% dosed amount of radioactivity)

 

Day	Mean % radioactivity
0	117.3
7	101.0
14	106.9
21	110.3
28	135.3
34	120.6
Overall mean	115.2

 

Table 2. Mortality data

 

Dose concentration (mg/l)	% eggs hatched after 6 days	% mortality after 34 days
0	100	2.5
1.0	100	8.8
3.2	100	1.2
10	100	5.0
32	100	6.2
100	100	66
320	100	100

 

 

Table 3. Growth of eggs/larvae of fish exposed to test substance

 

Dose concentration (mg/l)	No. fish	Mean final length (cm)	Mean final dry weight (mg)
0	78	1.32±0.17	1.83±0.09
1.0	73	1.36±0.15	2.32±0.44
3.2	79	1.30±0.14	1.96±0.18
10	76	1.31±0.19	2.31±0.83
32	75	1.34±0.15	2.11±0.27
100	27	1.30±0.25	3.49±1.71
320	0	n/d	n/d

n/d no data (all fish had died)

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions of this study, the LC50 was determined to be 81 µg/l, the NOEC was determined to be 32 µg/l and the LOEC was determined to be 100 µg/l.

Executive summary:

In a study conducted in accordance with OECD Guideline No. 210, Zebra fish (Brachydanio rerio) were exposed to the test material, Bardac 22 (Didecyldimethylammonium Chloride), for 34 days at concentrations of 0, 1.0, 3.2, 10, 32, 100 and 320 mg/l. 4 replicates of 20 eggs/larvae were dosed per concentration.  Hatching, mortality, morphological and behavioural development, body weight and body length were the test parameters examined.

The test substance had no effect on hatching. All fish died at a test substance concentration of 320 µg/l. At 100 µg/l fish were observed swimming on the surface. No other observations were made at any other test substance concentrations. No morphological observations were made. The test substance had no effect on body lengths. Body weights appeared to increase at 100 µg/l.

Under the conditions of this study, the 34-day LC₅₀was determined to be 81 µg/l, the NOEC was determined to be 32 µg/l and the LOEC was determined to be 100 µg/l.

Description of key information

One key study is available.  The study was conducted in accordance with OECD guideline 210, with no deviations and compliant with GLP.  The species tested was Brachydanio rerio (zebra fish), which were exposed to Bardac 22 (read-across from structural analog DDAC) for 34 days. Under the conditions of this study, the 34-day LC50was determined to be 81 µg/L, the NOEC was determined to be 32 µg/L and the LOEC was determined to be 100µg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

32 µg/L

Additional information

In a study conducted in accordance with OECD Guideline No. 210, Zebra fish (Brachydanio rerio) were exposed to the test material, Bardac 22 (Didecyldimethylammonium Chloride), for 34 days at concentrations of 0, 1.0, 3.2, 10, 32, 100 and 320mg/l. 4 replicates of 20 eggs/larvae were dosed per concentration.  Hatching, mortality, morphological and behavioural development, body weight and body length were the test parameters examined. The test substance had no effect on hatching. All fish died at a test substance concentration of 320 µg/l. At 100 µg/l fish were observed swimming on the surface. No other observations were made at any other test substance concentrations. No morphological observations were made. The test substance had no effect on body lengths. Body weights appeared to increase at 100 µg/l.

Under the conditions of this study, the 34-day LC₅₀was determined to be 81 µg/l, the NOEC was determined to be 32 µg/l and the LOEC was determined to be 100µg/l.