Registration Dossier

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 June 1997 - 15 August 1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The test was conducted according to EC test guidelines, and in compliance with GLP. However it was noted, that no test material purity was provided, no analysis of test solutions was performed so only nominal values were available for the EC50 calculation, and the pH of each test group was significantly higher than the pH of the control group.
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
GLP compliance:
yes (incl. certificate)
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Direct dispersion in water
Test organisms (species):
Leuciscus idus
Details on test organisms:
TEST ORGANISM
- Common name: Golden orfe
- Age at study initiation (mean and range, SD): “juvenile”
- Length at study initiation (length definition, mean, range and SD): 5.8 cm (sd=0.4)
- Weight at study initiation (mean and range, SD): 2.07g(sd=0.78)
- Feeding during test: none

ACCLIMATION
- Acclimation period: August 4-August 11, 1997
- Acclimation conditions (same as test or not):same as test
- Type and amount of food: Tetramin ® flake food
- Feeding frequency: discontinued 48 hours prior to start of definitive study
- Health during acclimation (any mortality observed): Approximately 3% mortality in the 7 days prior to the start of the test

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Test temperature:
See table in material and methods section below
pH:
See table in material and methods section below
Dissolved oxygen:
See table in material and methods section below
Nominal and measured concentrations:
Nominal only: 0 (control), 100, 180, 320, 560, 1000 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: glass, completely filled with 22L of test media
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): 24 hour complete replacement
- No. of organisms per vessel:10
- Biomass loading rate: 1.04 g bodyweight/litre

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: laboratory tap water dechlorinated by passage through an activated carbon filter (Purite Series 500)
- Total organic carbon: 2.3 mg/L
- Metals: iron, copper, zinc, boron, barium and nickel
- Pesticides: no
- Chlorine: 0.14
- Alkalinity: 137 mg/L
- Conductivity: 614

OTHER TEST CONDITIONS
- Photoperiod:16 hours light, 8 hours dark, 20 minute dawn and dusk transition period.

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Observations at 3, 6, 24, 48, 72, and 96 hours after the start of exposure
- Sublethal effects: Swimming at surface, swimming at bottom, loss of equilibrium, moribund.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 0, 100, 180, 320, 560, 1000 mg/L.
- Range finding study
- Test concentrations: 0.1, 10, 100, 1000 mg/L.
- Concentartions selected for the definitive study: 100, 180, 320, 560 and 1000 mg/l
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
130 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
180 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Behavioural abnormalities: Swimming at surface, swimming at bottom, loss of equilibrium at 180 mg/L. At 24 hours, all organisms exposed at or above 180 mg/L were dead.
- Mortality of control: none
- Other adverse effects control: none

Table 1. Cumulative mortality by hour

Nominal Concentration (mg/L)

Cumulative Mortality (Initial Population=10)

% Mortality

3 hours

6 hours

24 hours

48 hours

72 hours

96 hours

Control

0

0

0

0

0

0

100

0

0

0

0

0

0

180

0

3

10

10

10

100

320

10

10

10

10

10

100

560

10

10

10

10

10

100

1000

10

10

10

10

10

100

Conclusions:
The 96 hour LC50 based on nominal test concentrations was 130 mg/l with 95% confidence limits of 100-180 mg/l. The No Observed Effect Concentration was 100 mg/l.
Executive summary:

A study was performed to determine the acute toxicity to freshwater fish of the test material 1,3-Bis(aminomethyl)cyclohexane (1,3-BAC). The study was performed according to OECD test guideline 203 and EC guideline C1, and in compliance with GLP.

Leuciscus idus (Golden orfe) were exposed to the test material in dilution water for up to 96 hours in a semi static test. The concentration groups were as follows; 0 (control group), 100, 180, 320, 560, and 1000 mg/L.

Behavioural anomalies were seen in fish exposed at 180 mg/L and above; after 24 hours, all fish exposed at 180 mg/L and above were dead. The 96-hour No Observed Effect Concentration (NOEC) was 100 mg/L, and the EC50was 130 mg/L.

Description of key information

96 hour LC50 in Golden orfe = 130 mg/L;  LD100=180 mg/L.  No mortality at 100 mg/L.

Key value for chemical safety assessment

LC50 for freshwater fish:
130 mg/L

Additional information

A study was performed to determine the acute toxicity to freshwater fish of the test material 1,3-Bis(aminomethyl)cyclohexane (1,3-BAC). The study was performed according to OECD test guideline 203 and EC guideline C1, and in compliance with GLP.

Leuciscus idus (Golden orfe) were exposed to the test material in dilution water for up to 96 hours in a semi static test. The concentration groups were as follows; 0 (control group), 100, 180, 320, 560, and 1000 mg/L.

Behavioural anomalies were seen in fish exposed at 180 mg/L and above; after 24 hours, all fish exposed at 180 mg/L and above were dead. The 96-hour No Observed Effect Concentration (NOEC) was 100 mg/L, and the EC50was 130 mg/L.