Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
96 hours
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant study conducted according to OECD guideline 203 (1992)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch number - LPBS2A2005Appearance- white, crystalline and odourless
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):Not applicable

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Analytical samples were taken from freshly prepared and 24 hour aged samples for each of the four 24 hpur exposure periods. In addition a sample was taken after 4 hours during the initial 24 hour exposure period.

Test solutions

Vehicle:
no
Details on test solutions:
A nominal test substance concentration of 100 mg/L was prepared. At each point of time (start, 24, 48, and 72 hours) nominal 500 mg test substance were diluted in 5000 mL dilution water by stirring for 5 minutes in the dark.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
The fish were obtained from Fa. Tomy`s Zoo GmbH, Joseph Streblgasse 6, 2345 Brunn am Gebirge. The fish were acclimated in the laboratory for for approximately 40 weeks prior to use.Feed: TetraMin; Tetra Werke, Dr.rer.nat. Ulrich Baensch GmbH, D-49304 Melle.Exposure: no feeding (last feeding about 24 hours before start of the exposure).As the allocation of the fish to their groups was performed using a randomisation procedure the size and the weight of the control fish is assumed to be representative for the entity of all fish used.Length - 3.21 (SD: 0.21) (mean of control group at the end of study).Weight - 0.55 (SD: 0.13) (mean of control group at the end of study).

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
Not applicable

Test conditions

Hardness:
220 mg CaCO3/L.
Test temperature:
The temperature ranged between 20 and 21 °C.
pH:
pH: 7.9 to 8.2 in the control medium and between 6.2 and 8.0 in the test substance medium. The pH of the test and control media was within the rangegiven by the guideline.
Dissolved oxygen:
At least 61 % of the saturation value at the corresponding temperature throughout the test period. (range 61 - 99%)
Salinity:
Not applicable.
Nominal and measured concentrations:
Nominal exposure concentrations; control and 100 mg/L. Mean measured exposure concentrations: 95.07 mg/L
Details on test conditions:
Test vessels were full glass vessels (29 cm x 20 cm x 24 cm), filled with 5 L of control and test medium and covered with transparent plasticlids. Each test vessel had seven fish, with a single replicate per concentration. Maximum loading of 1.0 g fish/litre. A 16 hour light and 8 hour dark cycle was in operation during the study.
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
There was no mortality during the exposure period in either the control or the 100 mg/L treatment.
Results with reference substance (positive control):
Not applicable
Reported statistics and error estimates:
Not applicable, the results were based on observation of the data.

Any other information on results incl. tables

The analytical results are as follows:

Nominal concentration (mg/L)

Timepoint (h)

Measured concentration (mg/L)

Replicate 1

Replicate 2

Mean

100

0

99.91

100.92

100.42

100

4

96.65

98.59

97.62

100

24 (old)

99.47

97.38

98.43

100

24 (new)

93.58

95.07

94.33

100

48 (old)

97.26

85.89

91.58

100

48 (new)

94.98

95.92

95.45

100

72 (old)

81.63

80.89

81.26

100

72 (new)

106.33

99.34

102.84

100

96 (old)

104.22

96.82

100.52

Overall mean

-

-

-

95.07

The limit of quantification was 3.55 mg/L. All of the control measurements were less than the LOQ.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The 96-hour LC50 determined was >100 mg succinic acid/L (nominal concentration). The NOEC (no-observed effect concentration) was 100 mg succinic acid/L.
Executive summary:

Juvenile D. rerio were exposed to a single succinic acid concentration of 100 mg/L in a semi-static 96 -hour acute toxicity test according to OECD 203 guidelines. The test design included an untreated control comprising of dilution water only. The concentration of succinic acid was verified analytically and the mean measured concentration was 95.07 mg/L.

The 96-hour LC50 determined was >100 mg succinic acid/L (nominal concentration). The NOEC (no-observed effect concentration) was 100 mg succinic acid/L.