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Ecotoxicological information

Long-term toxicity to fish

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Reference
Endpoint:
long-term toxicity to fish, other
Type of information:
calculation (if not (Q)SAR)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: accepted calculation method
Test organisms (species):
Pimephales promelas
Water media type:
freshwater
Dose descriptor:
NOEC
Effect conc.:
> 0.45 mg/L
Basis for effect:
other: expected NOEC based on ACR approach

Acute:Chronic Ration approach

Source

Description

ACR (90%-ile)

Expected NOEC (mg/L): LC50

(> 45 mg/L) / ACR

Table 40

All species (geometric mean)

71

>0.6

Table 40

All fish (geometric mean)

57

>0.7

Table 41

All species (individual species)

71.2

>0.6

Table 41

All fish (individual species)

70.1

>0.6

Table 42

Mode of action (narcotic) (*)

11.5

(>1)

Table 44

Fish (Pimephales promelas)

70

>0.6

Table 45b

Pimephales promelas / organics

39

>1

*not applicable for primary amines

- short term toxicity test on fish LC50 (96 h) mg/L: > 45 mg/L (nominal)

Conclusions:
table 40, 41, 42, 44, 45b: expected NOEC > 0.45 mg/L

Description of key information

No experimental data available.

Key value for chemical safety assessment

Additional information

In Annex IX, Section 9.1.6, Column 2 of Regulation (EC) No 1907/2006, it is laid down that long-term toxicity testing on fish shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on fish. According to Annex I of this regulation, the chemical safety assessment triggers further action when the substance or the preparation meets the criteria for classification as dangerous according to CLP-Regulation (EC) No 1272/2008 and its second adaptation 286/2011 or is assessed to be a PBT or vPvB.  The hazard assessment of the substance reveals that the substance is not a PBT, nor a vPvB substance, nor are there any further indications that the substance or its metabolites may be hazardous to the environment.   In Annex XI, Section 3, it is laid down that testing in accordance with sections 8.6 and 8.7 of Annex VIII and in accordance with Annex IX may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report. In accordance with Annex XI Section 3, it can be demonstrated in the risk assessment that the intermediate use of the substance do not pose an unacceptable risk for all environmental compartments as the risk characterization ratios (RCRs) of the chemical safety assessment are below 1 for all compartments (see Chemical Safety Report Ch. 10).    

Therefore, and for reasons of animal welfare, a long-term toxicity test on fish is not provided.      

In addition, the acute-to-chronic ratio (ACR) as determined following the ECETOC Technical Report No. 93 (Aquatic Hazard Assessment II; ECETOC, 2003) shows that a long-term NOEC for fish of > 0.45 mg/L is to be expected.   Moreover, the results from short-term toxicity tests on fish, Daphnia and algae demonstrate that aquatic invertebrates are the most sensitive trophic level tested. Hence, it may be concluded that results from a long-term fish test would not reveal a greater hazard than already determined by the available data. Therefore and for reasons of animal welfare, a chronic test on fish is not provided.  


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