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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:
2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Justification for type of information:
LANXESS Deutschland GmbH has registered five mono-constituent anthraquinone dyes of similar chemical structure using a category approach: Solvent Violet 36 (CAS No 82-16-6), Solvent Green 3 (CAS No 128-80-3), Reinblau RLW (CAS No 41611-76-1), Reinblau BLW (CAS No 32724-62-2) and Solvent Green 28 (CAS No 4851-50-7). Additional data were taken from another registered anthraquinone dye, Solvent Blue 104 (CAS No 116-75-6), leading to a category consisting of six members (see attached justification in IUCLID chapter 13).
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
not applicable
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
Test item concentration:
- the test item was added to test medium at a nominal concentration of 100 mg/L
- The test substance tended to float on the water surface and was therefore shaken vigorously with a vortex apparatus and treated with ultrasonic waves for 5 minutes
- Afterwards magnetic stirring was applied for a total period of three days in order to achieve maximum saturation of the test medium with the test
substance
- After stirring the 100 mg/L solution appeared to be a greyish green turbid dispersion with a floating layer; the solution was used as such.
Test organisms (species):
Cyprinus carpio
Details on test organisms:
- Source : Zodiac, proefacc, "De Haar Vissen", L.U., Wageningen, the Netherlands
- Mean length: 2.26 ± 0.19 cm
- Mean weight: 0.23 ± 0.06 g
- Characteristics: F1 from a single parent-pair bred in UV-treated water
- Reason for selection: This system has been selected as an internationally accepted species
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
218 mg/L CaCO3)
Test temperature:
19.6-21.6°C
pH:
7.6-7.9
Dissolved oxygen:
7.6-8.3 (mg/L)

Salinity:
n.a.
Conductivity:
no data
Nominal and measured concentrations:
100 mg/L test item
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Validity criteria fulfilled:
yes
Remarks:
(mortality in the controls < 10% by the end of the test; dissolved oxygen concentration above 60% of the air-saturation value throughout the exposure period; pH did not vary by more than 1 unit)
Conclusions:
Under the conditions of exposure Solvent green 28 induced no mortality or other visible effects in carp at a nominal concentration of 100 mg/L during the 96-hour test period. Hence, the 96h-LC50 was above 100 mg/L, the regulatory limit concentration.
Executive summary:

The study was conducted in accordance with the OECD Guideline for Testing of Chemicals No. 203 'Fish, Acute Toxicity Test' (1992). Under the conditions of the present test Solvent green 28 induced no mortality or other visible effects in carp at a nominal concentration of 100 mg/L during the 96-hour test period. Hence, the 96h-LC50 was above 100 mg/L, the regulatory limit concentration. This toxicity study is classified as acceptable and satisfies the guideline requirements for the acute Fish study.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Justification for type of information:
LANXESS Deutschland GmbH has registered five mono-constituent anthraquinone dyes of similar chemical structure using a category approach: Solvent Violet 36 (CAS No 82-16-6), Solvent Green 3 (CAS No 128-80-3), Reinblau RLW (CAS No 41611-76-1), Reinblau BLW (CAS No 32724-62-2) and Solvent Green 28 (CAS No 4851-50-7). Additional data were taken from another registered anthraquinone dye, Solvent Blue 104 (CAS No 116-75-6), leading to a category consisting of six members (see attached justification in IUCLID chapter 13).
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
no
Analytical monitoring:
yes
Vehicle:
no
Details on test solutions:
Pre-TREATMENT OF THE TEST ITEM:
- test item was added to test medium at a nominal concentration of 100 mg/L
- the mixture was treated with ultrasonic waves for 5 minutes
- afterwards magnetic stirring was applied for a total period of three days in order to achieve maximum saturation of the test medium with the test substance
- after stirring the 100 mg/L solution appeared to be a black turbid dispersion with a floating layer
Test organisms (species):
Cyprinus carpio
Details on test organisms:
- Source: Zodiac, proefacc, “De Haar Vissen", L.U. Wageningen, the Netherlands
- Acclimatisation: Stock held since 2007-09-18 and acclimatised to the test conditions since then
- Temperature: 19-21.6 °C
- Mean length: 2.25 +/- 0.19 cm
- Mean weight: 0.23 +/- 0.06 g
- Characteristics: F1 from a single parent-pair bred in UV-treated water
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
218 mg/L CaCO3
Test temperature:
19.0-21-6 °C
pH:
7.6-7.7
Dissolved oxygen:
7.6-8.4 mg/L (Oxygen)
Salinity:
n.a.
Conductivity:
no data
Nominal and measured concentrations:
Nominal concentration: 100 mg/L
Details on test conditions:
I. EXPOSURE CONDTITIONS:
- Test vessels: glass aquaria holding 6 L of test media
- Experimental design: 1 test concentration plus 1 control; 5 animals per test concentration
- Loading: 0.23 g fish per litre, i.e. 5 fish per 5 litres of test medium
- Temperature: 19.0 to 21.6°C
- Test item concentration/s: 100 mg/L
- Method of administration: direct weighing
- Medium renewal: none
- Criteria of effects: observations on mortality at 3:15, 24, 48, 72 and 96 hours

II. SAMPLING SCHEDULE (pH and oxygen concentrations):
- pH-value: at 0, 24, 48, 72 and 96 hours
- Oxygen-value: at 0, 24, 48, 72 and 96 hours
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Validity criteria fulfilled:
yes
Remarks:
(mortality in the controls < 10% by the end of the test; dissolved oxygen concentration above 60% of the air-saturation value throughout the exposure period; pH did not vary by more than 1 unit)
Conclusions:
No toxic effects against fish were observed under exposure conditions (96 h-LC50 > 100 mg/L). All results are expressed in terms of nominal concentrations.
Executive summary:

A study was performed to assess the acute toxicity to Danio rerio under static conditions. The study was conducted in accordance with Council Regulation (EC) No 440/2008, Method C.1 'Acute toxicity for Fish' (2008) which is in most parts equivalent to the OECD Guideline for Testing of Chemicals No. 203 'Fish, Acute Toxicity Test' (1992). The purpose was to determine that concentration which causes a 50% mortality rate (LC50) or, if conducted as a limit test, to determine the acute toxic effects at a maximum test concentration of 100 mg/L or at the limit of water solubility, respectively. No range-finding test preceded the main test. The test was conducted as static test with the test medium unchanged throughout the duration of the test. During the test a temperature range of 19.0-21.6°C was maintained in the test vessels. The the pH and the oxygen values were measured at the beginning of the test and every 24 hours thereafter. The validity criteria of the test were met. Auxiliaries used to prepare the test media were an ultrasonic bath and a magnetic stirrer. Observations were made on the number of dead fish and the incidence of sub-lethal effects after approx. 3, 24, 48, 72 and 96 hours of exposure. Under the conditions of the present test Solvent green 3 induced no mortality or other visible effects in carp at a nominal concentration of 100 mg/I during the 96 hour test period. Hence, the 96h-LC50 was above 100 mg/L, the regulatory limit concentration.

This toxicity study is classified as acceptable and satisfies the guideline requirements for the acute fish study.

Description of key information

No toxic effects against fish were observed under exposure conditions (96 h-LC50 > 100 mg/L). All results are expressed in terms of nominal concentrations.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
100 mg/L

Additional information

"Should read: >100 mg/L"

Under the conditions of exposure Solvent Green 3 (CAS 128 -80 -3) or Solvent Green 28 (CAS 4851 -50 -7) induced no mortality or other visible effects in carp at a nominal concentration of 100 mg/L during the 96-hour test period. Hence, the 96h-LC50 was above 100 mg/L, the regulatory limit concentration.