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Short-term toxicity to fish

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
12-09-2011 to 16-09-2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study to appropriate guideline with validility criteria met.
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
The data is read across from a similar substance in a category approach.
See chapter 13 for more details on the read across
Reason / purpose for cross-reference:
read-across: supporting information
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
Samples were taken for chemical analysis from the stock and all concentrations at the beginning and end of the test. 10 mL samples were initially taken and diluted 1:1 in leaching solution (see annex 1) and shaken for 10-15 minutes at approximately 150 RPM. Further dilutions to within the calibration curve were also made in leaching solution. Chemical analysis was conducted according to the procedure detailed below.
Vehicle:
no
Details on test solutions:
Approximately 1 g of the test substance was weighed out using the analytical balance for preparation of the stock solution. This solution was made up to 1 litre in a volumetric flask with the test medium and was stirred until use. The test substance dissolved readily. A light yellow homogeneous stock was observed. The pH of the stock solution was found to be 8.2 and was therefore not adjusted.

An appropriate amount of the stock solution required to reach the desired concentration in a total volume of 3 litres was pipetted into a 3 liter
volumetric flask. The flask was then brought up to volume and after homogenization transferred into the aquaria. This procedure was repeated for
each of the following test concentrations: 4.2, 9.3, 20.6, 45.45 and 100 mg/L.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
The test was performed with juvenile Danio rerio (zebra fish), which were cultured internally and were accepted for use in testing according to laboratory standard operating procedures and as recommended in the corresponding guideline . The original parent batch was obtai-ned from the University of Wageningen (Zodiac) breeding facility. The fish in stock were fed one to three times per day with commercially available dry, deep frozen food, or fresh Artemia salina nauplii /juvenile Daphnia magna neonates. Feeding was stopped 24 hours before the test was started, and the
animals were not fed during the test. A representative number of test fish (10 at random) were measured for their length and weighed to assess
compliance with guideline criteria.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
After exposure fish were inspected for physical effects. None were observed. Fish were also measured to ensure compliance with guideline criteria.
Hardness:
12.1 º dH which is equivalent to 216 mg/L as calcium carbonate
Test temperature:
21.3 to 21.6°C.
pH:
7.5 to 8.2.
Dissolved oxygen:
5.5 to 9.0 mg/L
Salinity:
-
Nominal and measured concentrations:
See other information field below for analytical recovery table.
Details on test conditions:
The test was performed as a static test which means the test media was not replaced during the 96 hours of the test. Suitability of the test design was determined in preliminary studies where analytical stability measurements were made. The minimum requirement of 7 fish per test concentration and control were used for ethical reasons.

Under otherwise identical test conditions, the fish were exposed to the chosen concentrations of the test substance as described below and mortality and sub-lethal effects were recorded at least within the first six hours and then at approximately 24, 48, 72 and 96 hours. The fish were considered dead when a lack of opercular movement was observed and touching of the caudal peduncle produced no reaction. Dead fish were removed from the test vessels directly after being observed, which was checked several times up to 4 hours on the first day for ethical reasons and at least twice each day on subsequent days. In addition to death, sub-lethal effects such as erratic swimming, loss of reflex, increased excitability, lethargy, changes in
physiology, discoloration, pigmentation, excessive mucous production, hyperventilation, opaque eyes, curved spine or hemorrhaging were recorded if observed. Fish that were convulsing or showing other severe forms of distress not considered transient in nature and likely to become more severe before the exposure is terminated, were sacrificed for humane reasons. These fish were treated as having died in the test.

The fish were randomly placed in the test vessels which were positioned in the test room in a random manner. During the test the vessels were
covered with glass plates. The test solutions present in the test vessels were aerated with water-saturated air purified by an active coal filter and a cotton filter during testing.

The average length of a sample of 10 fish randomly taken from the test animals at the end of the test was 2.7 cm with a minimum of 2.6 and a maximum of 2.9 cm long. Average weight was 0.32 g. The mean biomass loading was 0.75 g/L. The results of the length and mass determination are
presented in Table 4. The general criteria set for the test animals in the study plan and guideline was therefore met.
Reference substance (positive control):
no
Remarks:
Not Conducted for Ethical Reasons
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
67.4 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: Nominals used due to 96 hr recoveries >80 %
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
35.7 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
45.45 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
No additional observations in results. Endpoints based on test chemical as received not yet corrected for purity. Test substance measured at start and end of test stability was > 80% of Nominals at all concentrations and hence nominal values were used.
Results with reference substance (positive control):
Not Conducted
Reported statistics and error estimates:
Trimmed Spearman Karber Graphical method using Toxcalc 5.023 was used. Confidence limits could not be calculated.
Sublethal observations / clinical signs:

Analytical Results

Table 1 Summary of analytical results

Concentration

(mg/L)

T=0 h Concentration

T=0h % of Nominal

T=96h Concentration

T=96 % of Nominal

0 (Control)

<LOD

--

<LOD

--

4.2

4.83

115

3.61

85

9.3

8.38

90

9.02

96

20.6

18.31

88

20.16

97

45.45

39.77

87

46.43

102

100

91.6

91.6

n.d

n.d

Validity criteria fulfilled:
yes
Conclusions:
Study can be considered reliable without restrictions. The test is reliable because it is performed according to standard OECD guideline 203 under GLP condition and all validity criteria were fulfilled. The test substance was stable during the test and >80% of the nominal test substance concentration was measured at start and end of the test. Therefore nominal test concentrations were used for the dose-response curve. The calculated endpoints are therefore adequate for C&L and risk assessment purposes.
Executive summary:

The acute toxicity of Aromatic Hydrocarbons, C10-13, Reaction Products With Branched Nonene Sulphonated to the fresh water fish Danio rerio (zebra fish) was tested under static conditions with reconstituted Dutch Standard Water (DSW) water for 96 hours in accordance with the OECD and EEC guidelines (Ref 1&2) for testing of chemicals. The test was performed in compliance with Good Laboratory Practice (GLP).

The test chemical is soluble in water at the concentrations tested. A non GLP preliminary test with the test substance showed no lethal effect at 10 mg/L and 100% effect at 100 mg/L. The definitive test was performed with the following nominal test concentrations including a control: 4.2, 9.3, 20.6, 45.45 and 100 mg/L

The NOEC for the test substance was determined as 45.45 mg/L.

The LC50 calculated using the Spearman Karber Graphical Method was a 67.4 mg/L

These results are based on the test chemical as received as described in the analysis certificate. No corrections for active ingredient have been made. Endpoints are based on results after 96 hours only.

The results of the chemical analyses show that the measured concentration of test substance in all concentrations remained stable over a 96 hour period based on the C10 component of the test substance. Nominal concentrations were therefore used for endpoint determinations.

Description of key information

The acute toxicity of Sodium diisobutylnaphthalenesulphonate to fish is read across from the structurally related substance Aromatic Hydrocarbons, C10-13, Reaction Products With Branched Nonene Sulphonated.

The LC50 calculated for this substance using the Spearman Karber Graphical Method was a 67.4 mg/L. These results are based on the test chemical as received as described in the analysis certificate. The results of the chemical analyses show that the measured concentration of test substance in all concentrations remained stable over a 96 hour period based on the C10 component of the test substance. Nominal concentrations were therefore used for endpoint determinations.

The purity of Aromatic Hydrocarbons, C10-13, Reaction Products With Branched Nonene Sulphonated as given on the CoA was 52.95%. Correcting the LC50 for this purity results in an LC50 of 35.7 mg/L

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
35.7 mg/L

Additional information

The acute toxicity of Sodium diisobutylnaphthalenesulphonate to fish is read across from the structurally related substance Aromatic Hydrocarbons, C10-13, Reaction Products With Branched Nonene Sulphonated.

The toxicity of Aromatic Hydrocarbons, C10-13, Reaction Products With Branched Nonene Sulphonated

substance to the fresh water fishDanio rerio(zebra fish) was tested under static conditions with reconstituted Dutch Standard Water (DSW) water for 96 hours in accordance with the OECD and EEC guidelines (Ref 1&2) for testing of chemicals. The test was performed in compliance with Good Laboratory Practice (GLP).

The test chemical is soluble in water at the concentrations tested. A non GLP preliminary test with the test substance showed no lethal effect at 10 mg/L and 100% effect at 100 mg/L. The definitive test was performed wih the following nominal test concentrations including a control: 4.2, 9.3, 20.6, 45.45 and 100 mg/L

The NOEC for the test substance was determined as 45.45 mg/L.

The LC50 calculated using the Spearman Karber Graphical Method was a 67.4 mg/L

These results are based on the test chemical as received as described in the analysis certificate. No corrections for active ingredient have been made. Endpoints are based on results after 96 hours only.

The results of the chemical analyses show that the measured concentration of test substance in all concentrations remained stable over a 96 hour period based on the C10 component of the test substance. Nominal concentrations were therefore used for endpoint determinations.

The purity of Aromatic Hydrocarbons, C10-13, Reaction Products With Branched Nonene Sulphonated as given on the CoA was 52.95. Correcting the LC50 for this purity results in an LC50 of 35.7 mg/L