Registration Dossier

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 predicted database
Qualifier:
according to guideline
Guideline:
other: Refer below principle
Principles of method if other than guideline:
Data was estimated for the determination of toxicity of test chemical on fish.
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Test organisms (species):
Pimephales promelas
Details on test organisms:
- Common name: Fathead minnow
Test type:
static
Water media type:
freshwater
Total exposure duration:
96 h
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
5.147
Nominal / measured:
estimated
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: not specified
Validity criteria fulfilled:
not specified
Conclusions:
Based on the QSAR prediction done using the Danish (Q)SAR Database, the 96 hours LC50 was estimated to be 5.147 mg/l on Pimephales promelas for tested substance with mortality effects. Thus based on this (LC50) value, it can be concluded that the substance can be classified as toxic in the category of aquatic chronic 2 as per the criteria of CLP regulation.
Executive summary:

Prediction done using average value of both models i.e Leadscope and SciMatics SciQSAR model and the result were predicted in Battery model. Based on the QSAR prediction done using the Danish (Q)SAR Database, the 96 hours LC50 was estimated to be 5.147 mg/l on Pimephales promelas for tested substance with mortality effects. Thus based on this (LC50) value, it can be concluded that the substance can be classified as toxic in the category of aquatic chronic 2 as per the criteria of CLP regulation.

Description of key information

Prediction done using average value of both models i.e Leadscope and SciMatics SciQSAR model and the result were predicted in Battery model. Based on the QSAR prediction done using the Danish (Q)SAR Database, the 96 hours LC50 was estimated to be 5.147 mg/l on Pimephales promelas for tested substance with mortality effects. Thus based on this (LC50) value, it can be concluded that the substance can be classified as toxic in the category of aquatic chronic 2 as per the criteria of CLP regulation

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
5.147 mg/L

Additional information

Based on the various predicted data and experimental studies from different sources including secondary databases, authoritative database and study reports were reviewed for the evaluation of the effects of test chemical and structurally and functionally similar read across chemicals on the mortality of fishes. The studies are as mentioned below:

Prediction done using average value of both models i.e Leadscope and SciMatics SciQSAR model and the result were predicted in Battery model. Based on the QSAR prediction done using the Danish (Q)SAR Database, the 96 hours LC50 was estimated to be 5.147 mg/l on Pimephales promelas for tested substance with mortality effects. Thus based on this (LC50) value, it can be concluded that the substance can be classified as toxic in the category of aquatic chronic 2 as per the criteria of CLP regulation.

Based on the prediction done by EPI suite, on the basis of similarity of structure to chemicals for which the aquatic toxicity has been previously measured by structure-activity relationships (SARs) program, the LC50 value for short term toxicity to fish was predicted. On the basis of this program, the LC 50 value for short term toxicity to fish was predicted to be 8.427 mg/l for test chemical in 96 hrs. Based on this value it can be concluded that the substance is considered to be toxic to aquatic environment and can be classified in aquatic chronic 2 category as per the criteria mentioned in CLP regulation.

Above data further supported by the third weight of evidence study from authoritative database. Principle of this study was to determine the short term toxicity of test chemical on the mortality rate of fishes. Test conducted under the static system for 96 hours. Based on the mortality of fishes due to the test chemical exposure, the LC50 value was determined to be 2.5 mg/l. Based on the LC50 value, test chemical consider to be toxic and can be consider to be classified in aquatic chronic category 2 as per the CLP classification criteria.

Similar study was conducted to determine the effect of test chemical on the mortality of fishes. Oryzias latipes (Japanese Medaka Medaka) was used as test organism. Test conducted under the static system for 96 hours. Based on the mortality of fishes Oryzias latipes (Japanese Medaka Medaka), due to the test chemical exposure for 96 hours, the LC50 value was observed to be 6.4 mg/l with 95% CI of 3.3 mg/l to 11 mg/l.

Thus based on the above all studies and effects observations, it was concluded that the test chemical was toxic and classified in aquatic chronic category 2 as per the CLP classification criteria.