Registration Dossier

Administrative data

Endpoint:
long-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication which meets basic scientific principles

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 204 (Fish, Prolonged Toxicity Test: 14-day Study)
Deviations:
not specified
Principles of method if other than guideline:
The information given in the publication suggests that OECD 204 formed the basis of this test procedure.
Reference is made also to Alabaster JS and Abrams FSH (1964), in: Adv. Water Poll. Res., Proc. 2nd Int. Conf. Tokyo, Vol. 1, Pergamon Press, Oxford. The extent of implementation of this publication is however unclear.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No data
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:
4 times immediately before and 4 times immediately after renewal of the solution (for 2 test concentrations of the compound);
recovery factors were calculated as the geometric mean of concentrations found immediately before and after renewal of the solutions.

Test solutions

Vehicle:
yes
Details on test solutions:
Carrier solvent acetone (72 µL/L) used for most aldehydes (not stated for the specific case of butanal).

Test organisms

Test organisms (species):
Poecilia reticulata
Details on test organisms:
- Common name: guppy
- Source: laboratory-reared;
- Age at start of experiment: 2-3 months;
- Acclimation period to test water: at least 12 days;
- Feed: fed daily with commercial food (TetraPhyll, Tetra Werke, Germany)

Study design

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

Test conditions

Hardness:
No data
Test temperature:
21-23°C
pH:
all values within 6.5-7.5
Dissolved oxygen:
Oxygen content was sometimes found to be very low (approx. 3 mg/L) 24 h after preparation of the solutions. This was probably due to growth of bacteria. Data from tests in which low oxygen content was accompanied by mortality were discarded.
Salinity:
Not applicable
Nominal and measured concentrations:
Not reported in the publication.
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type: closed (glass lids)
- Material, size, headspace, fill volume: 1.5 L glass vessel with 1.4 L test volume
- Aeration: most probable not (not reported)
- Renewal rate of test solution (frequency): daily
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): no control, only vehicle control
- No. of vessels per vehicle control (replicates): 1


OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod: 12 h/d
- Light intensity: not stated


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality (daily) for LC50 determination;
additionally other effects monitored (abnormal behavior)


TEST CONCENTRATIONS
- No details on nominal concentrations applied and measured values. No data given on stability between water renewals
- Spacing factor for test concentrations: 1.8
- number of treatment groups (without control): at least 5 (not stated exactly for the respective compound)
Reference substance (positive control):
not specified

Results and discussion

Effect concentrations
Duration:
14 d
Dose descriptor:
LC50
Effect conc.:
13.7 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
Acute toxicity: log LC50 (14 days) for the guppy was reported to be 2.28 (LC50 in µmol/L), corresponding to an LC50 of 190.5 µmol/L or 13.7 mg/L.

Recovery factors

The LC50 data were calculated by logit transformation. The concentrations used in the calculations were based on the added amount of material. The resulting LC50 was then corrected for loss of the compound through evaporation etc. by multiplication with its recovery factor.


Fish showed no obvious toxic symptoms. There was a loss of appetite at higher concentrations. Most deaths occurred during the initial six days of exposure - general observations on the complete dataset, rather than specifically butanal.
Results with reference substance (positive control):
Not applicable
Reported statistics and error estimates:
LC50 data were calculated by logit transformation

Applicant's summary and conclusion

Conclusions:
Gupppues (Poecilia reticulata) were exposed to butanal for 14 days in a semi-static exposure study. The outcome of the study was a 14 day LC50 of 13.7 mg/L.
Executive summary:

In a comparative test programme apparently based on a standard acute aquatic toxicity study over 14 days (according to OECD 204), fish (guppy, Poecilia reticulata) were exposed to various aldehydes including n-butanal [123 -72 -8], isobutanal [CAS No. 78 -84 -2] and 3 -methylbutanal [CAS No. 590 -86 -3]. The test regimen was semistatic with the medium renewed daily. The stability of the test concentrations was analysed to calculate the recovery rate over the test interval. Nominal toxicity values were corrected for intermittent losses by multiplication with the recovery factors. No guideline was stated, but the basic test method and conditions are supposed to have adhered to OECD 204. The 14 day LC50 was calculated to be 13.7 mg/L.