RAL 3.0

Short-term toxicity to aquatic invertebrates

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Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Remarks:

One guideline study (OECD 202) is available for short-term toxicity in invertebrates. The GLP status is unclear. The 48-h EC50 in Daphnia magna is 156 mg/L in a static test; no analytical monitoring has been performed

Adequacy of study:

key study

Study period:

2003

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: : GLP status unclear, guideline study, available as unpublised report, minor restrictions, adequate for assessment. However, no analytical monitoring has been performed and the purity of the test substance was not specified.

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 aquatic invertebrates.

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 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

temperature variation was one degree Celsius higher than required in 67/548/EEC Annex V C.2

Deviations:

not specified

GLP compliance:

not specified

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:

Purity not specified

Sampling and analysis

Analytical monitoring:

no

Test solutions

Vehicle:

no

Details on test solutions:

Test concentrations were diluted from the stock solution.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnia magna STRAUS
Organisms were obtained from own culture and they were 6-24 h old.
Food: Scenedesmus subspicatus (green algae)

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Hardness:

Not measured

Test temperature:

20 ± 2°C

pH:

Begin test: 7.7 - 7.9
End test: 8.2 - 8.5

Dissolved oxygen:

Begin test: 8.0 - 9.1 mg/l
End test: 8.7 - 9.3 mg/l

Salinity:

Not applicable

Nominal and measured concentrations:

Nominal: 72, 86, 108, 115, 122, 130 and 144 mg/l

Details on test conditions:

Five instars per test vessel, 50 ml each, four vessels per test concentration were run. Tap water, which was used for cultures, was also used as test water.

Reference substance (positive control):

yes

Remarks:

kaliumdichromat

Results and discussion

Effect concentrations

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

156 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: : immobilisation

Details on results:

Immobilisation in control vessels (0 mg/l) remained under 10 %. EC50 of 156 mg/l (above observed water solubility) was extrapolated from the test.

Results with reference substance (positive control):

The EC50 with kaliumdichromat was 1.8 mg/l

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 to aquatic invertebrates

Executive summary:

One guideline study (OECD 202) is available for short-term toxicity in invertebrates. The GLP status is unclear. The 48-h EC50 in Daphnia magna is 156 mg/L in a static test; no analytical monitoring has been performed