RAL 3.0

Short-term toxicity to fish

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Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Remarks:

One GLP-compliant guideline study (OECD 203) is available for short-term toxicity in fish. The 96-h LC50 is 99 mg/L in zebra fish (Brachydanio rerio) in a static test; the concentrations were analytically verified (Solvay, 2008a).

Adequacy of study:

weight of evidence

Study period:

2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

guideline study available as unpublished report, no restrictions, fully adequate for assessment

Cross-reference

Reason / purpose for cross-reference:

read-across source

Remarks:

In the following is the data from the study available to determine the short-term toxicity of trisodium hexafluoroaluminate on fish.

Reference

No studies are available to determinate the toxicity to aquatic plants other than algae, of trisodium hexafluoroaluminate or calcium fluoride. Available studies on fluoride were used as read-across source. Effective concentrations were recalculated taking in account the different molecular weight of the source and target substance.

A 7 -day study was conducted on Lemna minor to assess the toxicity of fluoride in the presence of chloride and in hard water. Lemna minor was found to be relatively insensitive to fluoride with an IC50 value (frond number) of 391 mg/L F. This relates to 803.39 mg CaF2/L. and relates to 720 mg Na3AlF6/L

 

Reliable acute ecotoxicity test results are available for fish, invertebrates and algae. The 96-h LC50 in Brachydanio rerio is 99 mg/l from a GLP compliant OECD guideline study (Solvay, 2008a). An OECD guideline study is available for short-term toxicity in invertebrates, the 48-h EC50 in Daphnia magna is 156 mg/l (IWL, 1998). The 72-h ErC50 is 8.8 mg/l in the freshwater algae Pseudokirchneriella subcapitata (tested as Selenastrum capricornutum), the 72-h NOEC for growth rate is 1.0 mg/l from a GLP compliant OECD guideline study (Solvay, 2008b).

Long-term ecotoxicity tests with fish and invertebrates are not available.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

In the protocol it is stated that the purity of the test substance is >99%. However, in the certificate of analysis the purity of the test substance is reported as 96.9%. Furthermore, two concentrations instead of five were tested

Deviations:

not specified

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

impurity

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Cryolite
- Substance type: slighty coloured powder
- Analytical purity: 96.9%
- Composition of test material, percentage of components: Na 31%, Al 12.6%, F 53.3%
- Storage condition of test material: room temperature

Specific details on test material used for the study:

Name of test material (as cited in study report): Cryolite
- Substance type: slighty coloured powder
- Analytical purity: 96.9%
- Composition of test material, percentage of components: Na 31%, Al 12.6%, F 53.3%
- Storage condition of test material: room temperature

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

On day 0 samples were taken in duplicate from all test solutions. After 96 hours samples were taken in duplicate from all aquariums. The test solutions with a concentration of 100 and 150 mg/l were diluted 50 times with ISO water before analysis. The samples were stored at 2-8 °C for a maximum of 7 days.

Test solutions

Vehicle:

no

Details on test solutions:

Two days before test initiation a stock solution of 150 mg/l cryolite was prepared in duplicate by dissolving 601 mg in 4 litre ISO water. These stock solutions were continuously stirred for four days at 20 °C. On the day of test initiation the solution was filtered with filter paper (S&S 595 1/2) to remove undissolved particles

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

- Common name: zebra fish (Brachydanio rerio)
- Source: De Rifwachter, Hilversum, The Netherlands
- Food type: living water fleas and Tetramin
- Mean weight per fish: 0.452 gram
- Weight of the fish per litre test solution was lower than 1.0 gram

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test conditions

Hardness:

Not specified

Test temperature:

22.8 - 23.8 °C

pH:

7.1

Dissolved oxygen:

8.0 - 8.3 mg/l

Salinity:

Not applicable

Nominal and measured concentrations:

Nominal: 0, 100 and 150 mg/l
Measured: 0, 73 and 99 mg/l

Details on test conditions:

One aquarium (length, width and height of 30, 20 and 15 cm respectively) was prepared per test concentration containing 4 litre test solution and 8 zebra fish. The aquariums were covered with plastic plates. The test solutions were continuously aerated during the test. The light regime was 14 hours light and 10 hours dark. The zebra fish were not fed during the test.

OBSERVATIONS
24, 48, 72 and 96 hours after test initiation the behaviour and appearance of the surviving fish was recorded. On day 0 the pH, oxygen content and temperature of the ISO-water and the stock solution were measured. At test termination the water parameters were measured in all aquariums

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

95 h

Dose descriptor:

NOEC

Effect conc.:

99 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

other: behavior and general appearance

Effect concentrations 2

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

99 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

other: mortality and aberrant behavior

Details on results:

No mortality was observed in the control aquarium. At the tested concentrations the substance had no effect on mortaility, behavior and general appearance such as length of the fish.
Based on the certificate of analysis cryolite contains 53.3% fluoride. Based on these results, the difference between the nominal and the mean measured concentrations was >20% and for this reason the endpoints of the test were based on mean measured concentrations.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Because in RAL 3.0 Trisodium hexafluoroaluminate is present in a proportion of less than 1%, the preparation is not harmful

Executive summary:

Reliable acute ecotoxicity test results are available for fish, invertebrates and algae. The 96-h LC50 in Brachydanio rerio is 99 mg/l from a GLP compliant OECD guideline study (Solvay, 2008a).