Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to fish
Type of information:
calculation (if not (Q)SAR)
Adequacy of study:
weight of evidence
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:
Prediction done using ECOSAR v.1.11 model
GLP compliance:
no
Analytical monitoring:
not specified
Vehicle:
not specified
Test organisms (species):
other: Fish
Test type:
not specified
Water media type:
freshwater
Total exposure duration:
96 h
Test temperature:
25 °C
Reference substance (positive control):
not specified
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
646.836 mg/L
Nominal / measured:
estimated
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: ECOSAR Class:Neutral Organics
Validity criteria fulfilled:
not specified
Conclusions:
Based on the EPI Suite ECOSAR version 1.10 prediction model, the 96 hours LC50 was estimated to be 646.836 mg/l on Fish for test chemical on the basis of mortality effects.
Executive summary:

Using the EPI Suite ECOSAR version 1.11, the short term toxicity on fish was predicted for test chemical on the basis of effects observed in a static freshwater system. The lethal concentration LC50 value for the substance was estimated to be 646.836 mg/l for fish for 96 hr exposure duration. Based on this lethal value it can be concluded that the test chemical can be likely to be non toxic to aquatic environment and thus it is considered as not classified as per the CLP classification criteria.

Description of key information

Using the EPI Suite ECOSAR version 1.11, the short term toxicity on fish was predicted for test chemical on the basis of effects observed in a static freshwater system. The lethal concentration LC50 value for the substance was estimated to be 646.836 mg/l for fish for 96 hr exposure duration. Based on this lethal value it can be concluded that the test chemical can be likely to be non toxic to aquatic environment and thus it is considered as not classified as per the CLP classification criteria.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
646.836 mg/L

Additional information

Four studies including predicted data from validated tools and experimental data from authoritative database of test chemical and its structurally similar read across has been reviewed for short term toxicity fish and their results are summarized below

 

In first study by using the EPI Suite ECOSAR version 1.11, the short term toxicity on fish was predicted for test chemical on the basis of effects observed in a static freshwater system. The lethal concentration LC50 value for the substance was estimated to be 646.836 mg/l for fish for 96 h exposure duration. Based on this lethal value it can be concluded that the test chemical can be likely to be nontoxic to aquatic environment and thus it is considered as not classified as per the CLP classification criteria.

 

In another study from secondary source the short term toxicity of test chemical to fish was determined by performing the experiment for 48 h, the test organism used in the study was Leuciscus idus melanotus. The LC0 , LC50 and LC100 value of test chemical was determined to be 1200 mg/L, 1720 mg/L and 2000 mg/L after the exposure of test chemical to Leuciscus idus melanotus for 48 h.

 

Next study was conducted to assess the effect of test chemical on the mortality of fish Danio rerio. Test conducted according to OECD Guideline 203 (Fish, Acute Toxicity Test). The test substance was soluble in water, therefore, the stock solution was prepared by dissolving 1 gm of the test substance in 1 liters of potable water (passed through reverse osmosis system then the Stock solution was used for achieving test concentrations of 6.25 mg/L, 12.5 mg/L, 25 mg/L, 50 mg/L & 100 mg/L, respectively and Zebra Fish Danio rerio were exposed to these concentration for 96 hours. Bowl aquaria containing 2 liters of potable water (passed through reverse osmosis system) were loaded with 8 fishes. A static procedure was used for the study and it was conducted in compliance with the OECD guideline 203. After 96 hours of exposure to test item to various nominal test concentrations, LC0 was determine to be 100 mg/l. Based on the LC0, it can be consider that the chemical was not hazardous and can be consider to be not classified as per the CLP classification criteria.

 

Last study was reviewed from authoritative database in this the short term toxicity of test chemical to fish was determined by performing the experiment for 96 h, the test organism used in the study was Oryzias latipes. The experiment was conducted in semi-static condition at 24±1 °C. The Nominal concentrations used in the study was control, 27, 37, 52, 72, 100 mg/L, at geometric ratio of 1:4. The test vessel used was 5L closed vessel and no aeration was given. The test solution was renewed after every 24h, the number of organisms per vessel were 10/concentration, and number of vessels per concentration (replicates) was one and the Photoperiod given was room light, 16 hours light / 8 hours dark.

 The LC50 value of test chemical was determined to be 106 mg/L after the exposure of test chemical to Oryzias latipes for 96 h. By considering this LC 50 value test chemical it is concluded that test chemical is nontoxic to fish and cannot be classified as per CLP regulation.

 

By considering the results of all the studies mentioned above it is concluded that LC 50calue of test chemical is in range of 106 mg/L to 1720 mg/L. On the basis of this range LC 50 value the test chemical it is considered not hazardous to fish cannot classified as per the CLP classification criteria.