Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study, performed in conformity with GLP-principles
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Identity: LZ 1780
- Chemical name: L-Carnitine L-tartrate
- Lot number: 21205
- Expiry date: 09 December 2007
- Appearance: White crystalline powder
- Storage conditions: Room temperature
- Date received: 4 January 2006

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
The test concentration was measured using a LC-MS/MS method of chemical analysis. At the start of the definitive test, four samples (20 ml) were taken from the freshly-prepared control and test media. After 48 hours, the contents of the vessels from each group were pooled and four samples (20 ml) were taken for analysis. On each occasion, the samples were stored frozen for up to six days before two samples from each batch were provided for analysis.

Test solutions

Details on test solutions:
Identity and concentration of auxiliary solvent for dispersal: The test medium was prepared by direct addition of the test substance to water. See also "details on analytical methods".

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
Stock cultures of Daphnia magna were maintained in glass vessels containing approximately 0.8 litres of Elendt M4 culture medium in a temperature-controlled laboratory at nominally 20 ± 2°C. A photoperiod of 16 hours light : 8 hours dark was maintained, with periods of subdued lighting at the beginning and end of each light phase. The culture medium was renewed at least twice each week.
Cultures were fed daily with a mixed suspension of the unicellular green algae, Pseudokirchneriella subcapitata and Scenedesmus subspicatus, to provide nominally 0.1 to 0.2 mg carbon per daphnid, per day, except during the initial three days when a slightly lower ration was given. Culture conditions ensure that the stock animals reproduce by parthenogenesis.
The day before the start of the study, all juvenile Daphnia were removed from the laboratory cultures. The following morning, juveniles produced by the gravid (egg-bearing) adult Daphnia were removed from the culture vessels and held in a separate holding vessel; these animals, which were less than 24 hours old, were used in the test

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 d
Post exposure observation period:
Observations of the Daphnia in each control and test vessel were made after approximately 24 and 48 hours.

Test conditions

Hardness:
The total hardness and alkalinity of the batch of Elendt M4 medium used were 268 and 42.5 mg/l as CaCO3, respectively.
Test temperature:
Temperatures were within the range 19.5 to 20°C.
pH:
The pH values were within the range 6.92 to 7.82.
Dissolved oxygen:
Dissolved oxygen concentrations were within the range 93 to 96% air saturation value (ASV).
Salinity:
Freshwater used.
Nominal and measured concentrations:
A group of twenty Daphnia, less than 24 hours old, was exposed for 48 hours to a dilution of LZ 1780 at a nominal concentration of 100 mg/l. The test medium was prepared in Elendt M4 medium by the direct addition of the test substance to the dilution medium.
The mean measured concentrations of LZ 1780 in samples of test medium ranged between 82 and 104% of the nominal value during the test, giving an overall mean measured level of 92.8 mg/l.
Details on test conditions:
Environmental parameters remained within acceptable limits throughout the study.
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 92.8 mg/L
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 92.8 mg/L
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
92.8 mg/L
Details on results:
After 48 hours, no immobility had occurred.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The acute EC50 to Daphnia Magna was determined to be > 100 mg/l nominal (> 92.8 mg/l as mean measured concentration). Based on these results, the test item does not have to be classified and has no obligatory labelling requirement according to the European CLP-Regulations (GHS).
Executive summary:

The test item was tested for acute toxicity to Daphnia Magna in a static test, according to OECD-Guideline No. 202, EU-Testing Method C.2 and in conformity with GLP-principles. The study was performed from January - February 2006.

The acute EC50 to Daphnia Magna was determined to be > 100 mg/l nominal (> 92.8 mg/l as mean measured concentration). Based on these results, the test item does not have to be classified and has no obligatory labelling requirement according to the European CLP-Regulations (GHS).