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Short-term toxicity to fish

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Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study. non-GLP, no chemical control analysis
Reason / purpose:
reference to same study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Principles of method if other than guideline:
Method: DIN 38412, L 15
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The product was added to the test water without any pretreatment; subsequently the fish were placed into the aquaria
- Controls: medium control
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no
Test organisms (species):
Leuciscus idus
Details on test organisms:
TEST ORGANISM
- Common name: Golden orfe
- Source: Fischzucht Paul Eggers, D-2354 Hohenwestedt, Germany
- Age at study initiation (mean and range, SD): not indicated
- Length at study initiation (length definition, mean, range and SD): 8.2 cm (range 7.2 - 9.4 cm)
- Weight at study initiation (mean and range, SD): 5.8 g (range 4.2 - 8.9 g)
- Feeding during test: no

ACCLIMATION
- Acclimation period: about 5 month
- Acclimation conditions (same as test or not): as test conditions
- Type and amount of food: growing feed F/B 50
- Feeding frequency: daily ad libitum
- Health during acclimation (any mortality observed): 0 %

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
toal hardness: 2.5 mMol/L
Test temperature:
20 - 21 °C
pH:
7.3 - 7.6
Dissolved oxygen:
7.6 - 8.5 mg/l
Nominal and measured concentrations:
Nominal: 0, 10, 21.5, 46.4, 100 mg/l
Details on test conditions:
TEST SYSTEM
- Test vessel: all-glass aquaria
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 30 x 22 x 24 cm, 10 L
- Aeration: not indicated
- Renewal rate of test solution (frequency/flow rate): no
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 5.8 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to DIN 38 412
- Intervals of water quality measurement: daily

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16: 8 day night regime

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality and symptoms of intoxication after 0,4 , 24, 48, 72 and 96 h

TEST CONCENTRATIONS
- Spacing factor for test concentrations: about 2.2
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
46.4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
31.58 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
21.5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Validity criteria fulfilled:
not specified
Conclusions:
The LC50 of the test item on fish mortality is 31.58 mg/L and the NOEC is 10 mg/L.
Endpoint:
short-term toxicity to fish
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study. non-GLP, no chemical control analysis
Justification for type of information:
ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The structures of the target and source substances are identical and differ only with respect to the ratio of enantiomers where the target substance is a single pure L-isomer and the source substance is an equimolar mixture of L and D isomers.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The target substance, L-Citronellyl nitrile, is a mono-constituent substance (EC No. 695-909-8, CAS no. 35931-93-2).
The source substance, DL-Citronellyl nitrile, is a mono-constituent substance (EC No. 257-288-8, CAS no. 51566-62-2).
The source and target substances are both of high purity with a low concentration of impurities.

3. ANALOGUE APPROACH JUSTIFICATION
The read across hypothesis is based on structural similarity where the only difference between target and source molecules is the enantiomeric ratio. In a non-chiral environment the target and source chemicals will have identical properties but in the chiral environment of living organisms the enantiomers may possess different carcinogenicity and teratogenicity (in a chiral environment, stereoisomers might experience selective absorption, protein binding, transport, enzyme interactions and metabolism, receptor interactions, and DNA binding). Therefore, as a precaution for the developmental toxicity endpoint it is suggested that the NOAEL 250 mg/kg bw/day for L-Citronellyl nitrile is used instead of 500 mg/kg bw/day, as it is not known which form is more potent in vivo. All other endpoints are considered to be acceptable for this substance assuming that 50% of the target compound is available in the test material.

4. DATA MATRIX
Please refer to the data matrix included in the read-across justification document attached in Section 13.2.
Reason / purpose:
read-across source
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Principles of method if other than guideline:
Method: DIN 38412, L 15
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The product was added to the test water without any pretreatment; subsequently the fish were placed into the aquaria
- Controls: medium control
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no
Test organisms (species):
Leuciscus idus
Details on test organisms:
TEST ORGANISM
- Common name: Golden orfe
- Source: Fischzucht Paul Eggers, D-2354 Hohenwestedt, Germany
- Age at study initiation (mean and range, SD): not indicated
- Length at study initiation (length definition, mean, range and SD): 8.2 cm (range 7.2 - 9.4 cm)
- Weight at study initiation (mean and range, SD): 5.8 g (range 4.2 - 8.9 g)
- Feeding during test: no

ACCLIMATION
- Acclimation period: about 5 month
- Acclimation conditions (same as test or not): as test conditions
- Type and amount of food: growing feed F/B 50
- Feeding frequency: daily ad libitum
- Health during acclimation (any mortality observed): 0 %

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
toal hardness: 2.5 mMol/L
Test temperature:
20 - 21 °C
pH:
7.3 - 7.6
Dissolved oxygen:
7.6 - 8.5 mg/l
Nominal and measured concentrations:
Nominal: 0, 10, 21.5, 46.4, 100 mg/l
Details on test conditions:
TEST SYSTEM
- Test vessel: all-glass aquaria
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 30 x 22 x 24 cm, 10 L
- Aeration: not indicated
- Renewal rate of test solution (frequency/flow rate): no
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 5.8 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to DIN 38 412
- Intervals of water quality measurement: daily

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16: 8 day night regime

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality and symptoms of intoxication after 0,4 , 24, 48, 72 and 96 h

TEST CONCENTRATIONS
- Spacing factor for test concentrations: about 2.2
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
46.4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
31.58 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
21.5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Validity criteria fulfilled:
not specified
Conclusions:
The LC50 of the test item on fish mortality is 31.58 mg/L and the NOEC is 10 mg/L.

Description of key information

This endpoint was fulfilled using read across from 3,7-dimethyloct-6-enenitrile (EC 257-288-8 / CAS 51566-62-2), for which the following results were obtained.  

The short-term toxicity to fish was assessed using test guideline equivalent or similar to OECD 203.

The LC50 of the test item on fish mortality is 31.58 mg/L and the NOEC is 10 mg/L.

Key value for chemical safety assessment

LC50 for freshwater fish:
31.58 mg/L

Additional information