Dihydrogen (ethyl)[4-[[4-[ethyl(3-sulphonatobenzyl)amino]phenyl](2-sulphonatophenyl)methylene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, aluminium salt

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Experimental test result performed according to the OECD test guideline.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

The test concentrations selected for the study was 100 mg/l.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra Fish
- Length at study initiation (length definition, mean, range and SD): average 1.79 cm
- Weight at study initiation (mean and range, SD): average 0.1204 g
- Housing:The fishes were kept in a static tank in tap water passed through reverse osmosis system, under natural conditions along with proper feed and aeration.
- Duration of housing: 15 days
- Photoperiod: 16 hour light and 8 hour darkness
- Diet : Standard brand feed, once daily
- Acclimatization: seven days
- Feeding frequency: Once in a day

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

148.5 mg of CaCO3

Test temperature:

24.3 °C

pH:

7.04

Dissolved oxygen:

7.8 mg/l

Nominal and measured concentrations:

Nominal concentrations: 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Aquaria
- Material, size, headspace, fill volume: 5 liters of plastic aquaria filled with 2 liter of water
- Aeration: Aeration in test vessels was provided 1 day before the start of experiment
- No. of organisms per vessel: 8 fishes

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light and 8 hours dark

Reference substance (positive control):

no

Key result

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)

Validity criteria fulfilled:

yes

Conclusions:

Based on nominal concentrations, the median lethal concentrations [LC50 (96 h)] for test chemical on Danio rerio (Zebra Fish) was determined to be in the range of > 100 mg/L.

Executive summary:

Short term toxicity to fish was conducted for 96 hrs for assessing the effect of test chemical. The test was performed in accordance to OECD guideline No. 203 “Fish Acute Toxicity Test”. Zebra fish (Danio rerio) of average weight 0.1204g and average length of 1.79 cm was used as a test organism for the study. Test fishes were kept in a static tank in tap water passed through reverse osmosis system, under natural conditions along with proper feed and aeration. During the housing period, test fishes were fed once daily with standard brand fed. The test conditions during the housing of the test organisms were oxygen content of 7.8 mg/l, pH 7.4, water temperature 23.5°C and under a photoperiod of 16:8 hr light: dark conditions, respectively. Test concentrations selected for the study was 100 mg/L, respectively. Thus, limit test was perfromed. Total 8 fishes were exposed to test chemical in a 5 lit bowl aquaria containing 4 liters of potable water. The test vessels were placed in a room at a temperature of 24.3°C, pH 7.4, hardness of water 148.5 mg of CaCO3 and under a photoperiod of 16:8 hr light: dark conditions, respectively. Aeration in test vessels was provided 1 day before the start of the experiment. No mortalities were observed in the control vessel. Test fishes were moving slowly as compared to control. On the basis of effect of test chemical on mortality of the test organism, the LC0 and median lethal concentration (LC50 (96 h)) was determined to be 100 mg/l and >100 mg/L, respectively. Thus, based on the LC50 value, test chemical was considered to be non-toxic to aquatic fishes at environmental relevant concentrations and hence, considered to be classified 'not classified' as per the CLP classification criteria.

Description of key information

Short term toxicity to fish was conducted for 96 hrs for assessing the effect of test chemical (Experimental study report). The test was performed in accordance to OECD guideline No. 203 “Fish Acute Toxicity Test”. Zebra fish (Danio rerio) of average weight 0.1204g and average length of 1.79 cm was used as a test organism for the study. Test fishes were kept in a static tank in tap water passed through reverse osmosis system, under natural conditions along with proper feed and aeration. During the housing period, test fishes were fed once daily with standard brand fed. The test conditions during the housing of the test organisms were oxygen content of 7.8 mg/l, pH 7.4, water temperature 23.5°C and under a photoperiod of 16:8 hr light: dark conditions, respectively. Test concentrations selected for the study was 100 mg/L, respectively. Thus, limit test was perfromed. Total 8 fishes were exposed to test chemical in a 5 lit bowl aquaria containing 4 liters of potable water. The test vessels were placed in a room at a temperature of 24.3°C, pH 7.4, hardness of water 148.5 mg of CaCO3 and under a photoperiod of 16:8 hr light: dark conditions, respectively. Aeration in test vessels was provided 1 day before the start of the experiment. No mortalities were observed in the control vessel. Test fishes were moving slowly as compared to control. On the basis of effect of test chemical on mortality of the test organism, the LC0 and median lethal concentration (LC50 (96 h)) was determined to be 100 mg/l and >100 mg/L, respectively. Thus, based on the LC50 value, test chemical was considered to be non-toxic to aquatic fishes at environmental relevant concentrations and hence, considered to be classified 'not classified' as per the CLP classification criteria.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

Experimental study of the test chemical and various supporting studies of its structurally and functionally similar read across chemical has been reviewed for short term toxicity to fish endpoint. The studies were mentioned below:

 

In an experimental study from study report, short term toxicity to fish was conducted for 96 hrs for assessing the effect of test chemical. The test was performed in accordance to OECD guideline No. 203 “Fish Acute Toxicity Test”. Zebra fish (Danio rerio) of average weight 0.1204g and average length of 1.79 cm was used as a test organism for the study. Test fishes were kept in a static tank in tap water passed through reverse osmosis system, under natural conditions along with proper feed and aeration. During the housing period, test fishes were fed once daily with standard brand fed. The test conditions during the housing of the test organisms were oxygen content of 7.8 mg/l, pH 7.4, water temperature 23.5°C and under a photoperiod of 16:8 hr light: dark conditions, respectively. Test concentrations selected for the study was 100 mg/L, respectively. Thus, limit test was perfromed. Total 8 fishes were exposed to test chemical in a 5 lit bowl aquaria containing 4 liters of potable water. The test vessels were placed in a room at a temperature of 24.3°C, pH 7.4, hardness of water 148.5 mg of CaCO3 and under a photoperiod of 16:8 hr light: dark conditions, respectively. Aeration in test vessels was provided 1 day before the start of the experiment. No mortalities were observed in the control vessel. Test fishes were moving slowly as compared to control. On the basis of effect of test chemical on mortality of the test organism, the LC0 and median lethal concentration (LC50 (96 h)) was determined to be 100 mg/l and >100 mg/L, respectively.

 

Another short term toxicity to fish was conducted for 96 hrs for assessing the effect of test chemical. The test was performed in accordance to OECD guideline No. 203 “Fish Acute Toxicity Test” (Study report). Zebra fish (Danio rerio) of average weight 0.18 g and average length of 3.18 cm was used as a test organism for the study. Test fishes were kept in a static tank in tap water passed through reverse osmosis system, under natural conditions along with proper feed and aeration. During the housing period, test fishes were fed once daily with standard brand fed. The test conditions during the housing of the test organisms were oxygen content of 7.2 mg/l, pH 8.12, water temperature 24°C and under a photoperiod of 16:8 hr light: dark conditions, respectively. Test concentrations selected for the study was 100 mg/L, respectively. Thus, limit test was performed. Total 8 fishes were exposed to test chemical in a 5 lit bowl aquaria containing 4 liters of potable water. The test vessels were placed in a room at a temperature of 24.6°C, pH 7.98, hardness of water 142.5 mg of CaCO3 and under a photoperiod of 16:8 hr light: dark conditions, respectively. Aeration in test vessels was provided 1 day before the start of the experiment. No mortalities were observed in the control vessel. Test fishes were moving slowly as compared to control. On the basis of effect of test chemical on mortality of the test organism, the LC0 and median lethal concentration (LC50 (96 h)) was determined to be 100 mg/l and >100 mg/L, respectively.

 

For the test chemical from authoritative databases and secondary source, short term toxicity to fish study was conducted for 96 hrs for assessing the effect of test chemical. Oncorhynchus mykiss (Rainbow trout) (Juvenile) of 3.5 months old, 4.2 cm in length and 0.7 gm of weight was used as a test organism. The study was performed under static conditions at a temperature of 14°C for 96 hrs. On the basis of the effect of test chemical on mortality of test fishes, the 96 hr median lethal concentration (LC50) value was determined to be 412 mg/l.

 

On the basis of the above results, it can be concluded that the test chemicalwas considered to be non-toxic to aquatic fishesand hence, considered to be classified ‘not classified’ as per the CLP classification criteria.