Registration Dossier

Administrative data

Endpoint:
short-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: see 'Remark'
Remarks:
Guideline study; The oxygen content level within the 215 mg/l and 464 mg/l test concentration was observed to fall below 4 mg/l within the first hour of the study. However, the oxygen content was observed to recover quickly and at 4 h was > 6 mg/l, therefore the test can be considered to be valid.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: German standard DIN 38 412, part L15
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): D-Pantolactone (crystalline)
Purity: < 99 %
Water solubility: easily soluble according to the sponsor

Sampling and analysis

Analytical monitoring:
no

Test solutions

Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test item was added to the test water without any pretreatment, subsequently the fish were placed into the aquaria.

Test organisms

Test organisms (species):
Leuciscus idus
Details on test organisms:
TEST ORGANISM
- Common name: Golden orfe
- Source: Fischzucht Paul Eggers, 2354 Hohenweststedt, Germany
- Length at study initiation (length definition, mean, range and SD): 8.4 cm (range 7.5 - 9.3 cm)
- Weight at study initiation (mean and range, SD): 6.0 g (range 4.4 - 7.6 g)
- Method of breeding: Duration of housing: about 5 months Mortality during the last 2 weeks of housing: 0 %. Medical treatment: twice with 0.05 mg/l malachite green chloride, once with 10 mg/l tetracycline hydrochloride.
- Feeding during test: 1 day before and during exposure

ACCLIMATION
- Acclimation period: 3 days
- Health during acclimation (any mortality observed): none

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h

Test conditions

Hardness:
2.5 mmol/l
Test temperature:
20 - 21 °C
pH:
6.7 - 7.5
Dissolved oxygen:
3.7 - 8.8 mg/l
Nominal and measured concentrations:
Nominal test concentrations: 100, 215, 464 and 1000 mg/l. In addition, a control was tested in parallel.
Details on test conditions:
TEST SYSTEM
- Test vessel: glass aquaria (30 x 22 x 24 cm)
- Type (delete if not applicable): open / closed
- Fill volume: 10 l
- Aeration: slight
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 6 g fish/l test water


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted freshwater according to DIN 38412, Part II, 1982.
- Acid capacity: 0.8 mmol/l
- Conductivity: 4:1



OTHER TEST CONDITIONS
- Photoperiod: 16 : 8 hours day-night regime


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mobility and symptoms of intoxication after 1, 4, 24, 48, 72 and 96 h

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
464 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
681.2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Reported statistics and error estimates:
The LC50 value was calculated as the geometrical mean of the LC0 (464 mg/l) and LC100 (1000 mg/l) nominal values.

Any other information on results incl. tables

During the 96 h exposure to Test substance, mortalities were as follows:

Nominal test / Cumulative mortality (%) after x hours
concentration / 1 / 4 / 24 / 48 / 72 / 96 /
(mg/l)
Control / 0 / 0 / 0 / 0 / 0 / 0 /
100 / 0 / 0 / 0 / 0 / 0 / 0 /
215 / 0 / 0 / 0 / 0 / 0 / 0 /
464 / 0 / 0 / 0 / 0 / 0 / 0 /
1000 / 0 / 0 / 0 / 90 / 100 / 100 /


Symptoms of intoxication:

Nominal test / Symptoms of intoxication after x hours
concentration / 1 / 4 / 24 / 48 / 72 / 96 /
(mg/l)
Control / - / - / - / - / - / - /
100 / - / - / - / - / - / - /
215 / - / - / - / - / - / - /
464 / - / - / - / - / - / - /
1000 / - / - / AT / AT / + / + /

Definitions of Symptoms:
-: No symptoms
+: All fish dead
A: Apathy
T: Tumbling

Behaviour of the test substance during the test:
No remarkable observations

Chemical Analysis:
No analytical dose-verification of the test item was carried out. Therefore, all results refer to nominal test concentrations of D-Pantolactone (crystalline).

Applicant's summary and conclusion