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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
11 November 1991 to to 15 November 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
analytical monitoring not conducted
Justification for type of information:
The analogue approach is used for the hazard assessment of toxicological, eco-toxicological and environmental fate endpoints for the registration Pentamid™ KH (EC 934-047-1). The hypothesis is that data can be read-across between Pentamid™ KH and its structural analogues, based on structural similarity and common breakdown/metabolic products (Scenario 1 of the Read-Across Assessment Framework (RAAF, ECHA, 2015)).

The substance and its analogue have not been shown to exhibit toxicity to aquatic organisms (based on short-term studies on all three trophic levels) or be inhibitory to degradative micro-organisms. While neither the substance nor its analogue have been shown to be readily biodegradable, both exhibit inherent primary degradability and are not expected to be highly persistent in the environment. The low solubility, high octanol-water partition coefficient and non-rapid degradation in the environment, attributable to both the substance and its analogue, suggest that long-term exposures may be of potential concern.

The sole classification for Pentamid™ KH is the precautionary aquatic chronic 4 category, based on low water solubility and a log Kow higher than 4.

Read-across data, all evaluated as reliable according to Klimisch scores of 1 or 2, to estimate the toxicity of the registered substance is used for fulfilling the data requirements of the REACH registration and classifying potential hazards. This read-across approach is adequate for the purposes of risk assessment and classification and labeling.

Reason / purpose:
read-across source
GLP compliance:
yes
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LOEC
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
No deaths were recorded.
Conclusions:
Exposure of Danio rerio (previously Brachydanio rerio) to concentrations ranging from 100 mg/L to 1,000 mg/L showed no mortality in the 96 h test. The 96 h NOEC is 1,000 mg/L and the 96 h LC50 and LOEC are both > 1,000 mg/L.

Description of key information

The key study was a static acute fish toxicity test on the effects of the substance, Hostagel HT 300, on the freshwater zebra fish Danio rerio (previously Brachydanio rerio) following OECD Guideline 203. Exposure of Danio rerio (Brachydanio rerio) to concentrations ranging from 100 mg/L to 1,000 mg/L showed no mortality in the 96-h test. The 96-h NOEC is 1,000 mg/L and the 96-h LC50 and LOEC are both > 1,000 mg/L. 

Key value for chemical safety assessment

LC50 for freshwater fish:
1 000 mg/L

Additional information