Registration Dossier

Administrative data

Endpoint:
adult fish: sub(lethal) effects
Type of information:
experimental study
Adequacy of study:
key study
Study period:
not stated
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to Guideline study with acceptable restrictions. In this test, the LC50 was determined and not the NOEC as required in OECD 204

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 204 (Fish, Prolonged Toxicity Test: 14-day Study)
Deviations:
yes
Remarks:
LC50 was determined instead of a NOEC
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Acetaldehyde
EC Number:
200-836-8
EC Name:
Acetaldehyde
Cas Number:
75-07-0
Molecular formula:
C2H4O
IUPAC Name:
acetaldehyde
Details on test material:
- Name of test material: Ethanal

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
yes
Details on test solutions:
- Chemical name of vehicle: acetone
- Concentration of vehicle in test medium: control fish were exposed to 72 µl acetone

Test organisms

Test organisms (species):
Poecilia reticulata
Details on test organisms:
TEST ORGANISM
- Common name: Poecilia reticulata
- Source: laboratory reared
- Age at study initiation: 2-3 month


ACCLIMATION
- Acclimation period: at least 12 days prior to experiment
- Acclimation conditions: same as test
- Type and amount of food: fish were fed a commercial food (TetraPhyll, Tetra Werke, Germany)
- Feeding frequency: daily

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
14 d

Test conditions

Test temperature:
21 - 23°C
pH:
pH was determined four times immediately before, and immediately after renewal of the test solution for to concentrations. Results are not given in the study
Dissolved oxygen:
Oxygen content was determined four times immediately before, and immediately after renewal of the test solution for to concentrations. Results are not given in the study
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type: closed
- Material, size, headspace, fill volume: 1.5 l glass vessels which contained 1.4 l of the test solution
- Renewal rate of test solution (frequency/flow rate): test solution was renewed daily
- No. of organisms per vessel: 10


OTHER TEST CONDITIONS
- Photoperiod: 12 hours light/12 hours dark


EFFECT PARAMETERS MEASURED: mortality


TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8

Results and discussion

Effect concentrationsopen allclose all
Duration:
14 d
Dose descriptor:
other: log LC50
Effect conc.:
2.9 µmol/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: log LC50 is given here which is originally stated in the report
Duration:
14 d
Dose descriptor:
LC50
Effect conc.:
794.3 µmol/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: converted value
Duration:
14 d
Dose descriptor:
LC50
Effect conc.:
ca. 35 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: converted value, based on a molar mass of 44.05 g/mol
Reported statistics and error estimates:
LC50 was calulates by logit transformation

Applicant's summary and conclusion

Validity criteria fulfilled:
not specified
Conclusions:
After an exposure period of 14 day, the LC50 was determined to be 35 mg/l based on nominal values. Although a NOEC and not a LC50 is required according to the guideline, study is suitable as supporting information in the chemical safety assessment.
Executive summary:

The prolonged toxicity of acetaldehyde was tested semi-static test over a period of 14 days similar to OECD 204. Guppies were used as test organisms. Fish were exposed to five test concentration using a spacing factor of 1.8. As endpoint, mortality was determined and LC50 was calculated by logit transformation. Analytical measurements could not be conducted because no reliable recovery factors could be determined and the results were therefore based on nominal values. The log LC50 which is stated in the report was calculated to be 2.9 µmol/l which corresponds to 35 mg/l based on nominal values.