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Long-term toxicity to fish

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Endpoint:
adult fish: sub(lethal) effects
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17 Nov - 01 Dec 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
Qualifier:
according to guideline
Guideline:
other: UBA (German Federal Environmental Agency) - method: Prolonged toxicity test with zebra fish - Brachiodanio rerio
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 204 (Fish, Prolonged Toxicity Test: 14-day Study)
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Stock solution of 1 g/L further diluted to final volumes.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: zebra fish
- Source: West Aquarium, delivery 30th April 1986

ACCLIMATION
- Type and amount of food: Altromin
- Health during acclimation (any mortality observed): <0.1% during last week before transfer to the test vessels


Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
14 d
Test temperature:
22.0 - 22.5 °C
pH:
7.0 - 7.2
Dissolved oxygen:
64 - 97%
Nominal and measured concentrations:
nominal: 0, 0.3, 1.0, 3.0, 10.0 and 30.0 mg of product/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 10 L glass aquaria containing 5 L testing solution
- Renewal rate of test solution: three times per week
- No. of organisms per vessel: 10

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Synthetic water

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light/ 8 h dark

EFFECT PARAMETERS MEASURED: mortality

Reference substance (positive control):
no
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
1.65 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
adult mortality

Table 1: Mortality of adult specimens in %:

Incubation time (in days)

Concentration [mg /L]

0

2

4

7

9

11

14

Control

0

0

0

0

0

0

0

0.30

0

0

0

0

0

0

0

1.0

0

0

0

0

0

0

0

3.0

0

0

0

0

0

0

0

10

0

80

80

100

100

100

100

30

0

100

100

100

100

100

100

Endpoint:
adult fish: sub(lethal) effects
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
Reason / purpose for cross-reference:
read-across source
Reference substance (positive control):
no
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
1.65 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
adult mortality
Remarks on result:
other: read-across from CAS 68955-20-4

Description of key information

14d NOEC (Danio rerio) = 1.65 mg/L (UBA guideline equivalent to OECD 204, read-across)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
1.65 mg/L

Additional information

Since no reliable long-term toxicity tests with fish are available for C16-20AS Na (CAS 91648-55-4), in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read-across to another structurally related substance was conducted. Read-across data available for C16-18AS Na (CAS 68955-20-4) were used considering animal welfare. Toxicity of alkyls sulfates is dependent on the carbon chain length. Homologues of C-chain length of C13 to C15 are considered as the most toxic from the whole Alkyl Sulfate Category. Toxicity of the chains from C16 and higher will decrease due to lower bioavailability as a consequence of reduced water solubility.

One non-GLP 14-day study with fish is available for C16-18AS Na (CAS 68955-20-4, BASF 2001). The test was performed according to a German UBA method for a prolonged toxicity test with zebra fish, equivalent to OECD 204 guideline. Zebrafish (Danio rerio) were exposed for 14 days under semi-static conditions to five test concentrations up to 30 mg/L of the test substance of 55% purity, corresponding to 16.5 mg a.i./L. No analytical measurements are available. The 14-day NOEC value was determined to be 1.65 mg a.i./L (nominal concentration). As the results show, mortality of fish occurred at the concentrations of 10 mg/L of product and higher (equal to 5.5 mg a.i./L). Fish mortality reaching 80% and more was seen already on day 2. On the other hand, no toxic effects are recorded at the concentration of 3 mg product/L (equal to 1.65 mg a.i./L) thoughout the whole testing period. Therefore, the reliable long term NOEC value for fish can be considered as 1.65 mg a.i./L.

Due to structure and property similarities with the tested category member it can be concluded that the above results apply also to C16-20AS Na (CAS 91648-55-4). The worst case NOEC value for fish is 1.65 mg/L.