Recyclamine R 501

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

calculation (if not (Q)SAR)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

accepted calculation method

Justification for type of information:

Data is from computational model developed by USEPA

Qualifier:

according to guideline

Guideline:

other: Modelling database

Principles of method if other than guideline:

Estimation 96 hrs LC50 value of test chemical on aquatic fish by EPI Suite ECOSAR version 1.11.

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

other: Fish

Test type:

static

Water media type:

freshwater

Total exposure duration:

96 h

Reference substance (positive control):

not specified

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

1 011.995 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: Neutral Organic SAR (Baseline Toxicity)

Validity criteria fulfilled:

not specified

Conclusions:

Based on effect of test chemical on the mortality of the test organism fish, the 96 hrs LC50 was estimated to be 1011.995 mg/l.

Executive summary:

The short-term toxicity of the test chemical to aquatic fish was predicted using EPI Suite ECOSAR version 1.11. On the basis of effect of test chemical observed in a static system on the mortality of the test organism during the 96 hr exposure duration, the lethal effect concentration (LC50) for the test chemical was estimated to be 1011.995 mg/l. Thus, based on the LC50 value, test chemical was considered as non-toxic and hence, considered to be ‘not classified’ as per CLP classification criteria.

Description of key information

An acute toxicity test was conducted for 96 hrs for assessing the effect of test chemical on Zebra fish (Danio rerio). The test was performed in accordance to OECD guideline No. 203 “Fish Acute Toxicity Test”. Zebra fish (Danio rerio) of average length of 1.9 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. Aeration in test vessels was provided till 1 day before the start of the experiment. The test chemical was prepared by dissolving 2000 mg of test chemical in 2000 ml of RO water. After stirring the stock solution was filtered and analytically detected and the concentration found to be 1000 mg/L.  The remaining test solutions were prepared by dilution from the above stock solution. Test chemical concentrations used for the study were 100 mg/l.Test chemical concentrations were analytically determined by UV-VIS spectrophotometer. Test chemical conc. used for the study were 0, 7.5, 15, 30, 60 and 120 mg/l. Total 7 fishes were exposed to test chemical in a 7 lit Polypropylene (PP) fish tank containing 4000 ml of potable water. The test vessels were placed in a room at a temperature of 21 -25°C, pH of 7.9 (average) and DO of 7.2 mg/l (average) and under a photoperiod of 16:8 hr light: dark conditions, respectively. Mortality in the control was 0%. The dissolved oxygen concentration remained above 60% of the air saturation value throughout the exposure period. Thus, fulfilling the validity criterion. All the test concentrations were analytical determined and at 96 hours of the exposure durations which were not maintained in the range of 80 -120%. Therefore, the analysis of the results was based on measured concentration. On the basis of effect of test chemical on mortality of the test organism, the 96 hr median lethal concentration [LC50 (96 h)] for test chemical on Danio rerio (Zebra Fish) was reported to be >80.11 mg/L (measured conc.) and >120 mg/l (nomnal conc.), respectively. Since, the test chemical is readily biodegradable in water, test chemical was considered as non-toxic to aquatic fishes and hence, considered to be 'not classified' as per the CLP classification criteria.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

120 mg/L

Additional information

Experimental and predicted data of the target chemical were reviewed for short term toxicity to fish endpoint which are summarized as below:

 

In an experimental study from study report, an acute toxicity test was conducted for 96 hrs for assessing the effect of test chemical on Zebra fish (Danio rerio). The test was performed in accordance to OECD guideline No. 203 “Fish Acute Toxicity Test”. Zebra fish (Danio rerio) of average length of 1.9 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. Aeration in test vessels was provided till 1 day before the start of the experiment. The test chemical was prepared by dissolving 2000 mg of test chemical in 2000 ml of RO water. After stirring the stock solution was filtered and analytically detected and the concentration found to be 1000 mg/L.  The remaining test solutions were prepared by dilution from the above stock solution. Test chemical concentrations used for the study were 100 mg/l.Test chemical concentrations were analytically determined by UV-VIS spectrophotometer. Test chemical conc. used for the study were 0, 7.5, 15, 30, 60 and 120 mg/l. Total 7 fishes were exposed to test chemical in a 7 lit Polypropylene (PP) fish tank containing 4000 ml of potable water. The test vessels were placed in a room at a temperature of 21 -25°C, pH of 7.9 (average) and DO of 7.2 mg/l (average) and under a photoperiod of 16:8 hr light: dark conditions, respectively. Mortality in the control was 0%. The dissolved oxygen concentration remained above 60% of the air saturation value throughout the exposure period. Thus, fulfilling the validity criterion. All the test concentrations were analytical determined and at 96 hours of the exposure durations which were not maintained in the range of 80 -120%. Therefore, the analysis of the results was based on measured concentration. On the basis of effect of test chemical on mortality of the test organism, the 96 hr median lethal concentration [LC50 (96 h)] for test chemical on Danio rerio (Zebra Fish) was reported to be >80.11 mg/L (measured conc.) and >120 mg/l (nomnal conc.), respectively. Since, the test chemical is readily biodegradable in water, test chemical was considered as non-toxic to aquatic fishes and hence, considered to be 'not classified' as per the CLP classification criteria.

In a prediction done using EPI Suite ECOSAR version 1.11, the short-term toxicity of the test chemical to aquatic fish was predicted. On the basis of effect of test chemical observed in a static system on the mortality of the test organism during the 96 hr exposure duration, the lethal effect concentration (LC50) for the test chemical was estimated to be 1011.995 mg/l.

 

On the basis of the above results, test chemical was considered as non-toxic to aquatic fishes at environmental relevant concentrations and hence, considered to be 'not classified' as per the CLP classification criteria.