[No public or meaningful name is available]

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

26 April 2016 to 28 April 2016

Reliability:

1 (reliable without restriction)

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 for cross-reference:

read-across source

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Remarks:

No analytical monitoring of the test item will be carried out due to the sponsor's request.

Reference substance (positive control):

yes

Remarks:

A positive control used potassium dichromate as the reference item at concentrations of 1.00, 2.00 and 4.00 mg/L.

Key result

Duration:

48 h

Dose descriptor:

EL50

Remarks:

WAF

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

NOELR

Remarks:

WAF

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

LOELR

Remarks:

WAF

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Validity criteria fulfilled:

yes

Remarks:

None of the control daphnids showed immobilization or other signs of disease or stress and the oxygen concentration at the end of the test was >7.13 mg/L (guideline is equal to or greater than 3 mg/L) in the control and the WAF test vessels.

Conclusions:

The test substance did not induce acute immobilisation of Daphnia magna in the Water Accommodated Fraction (WAF) with a nominal loading of 100 mg/L. The 48 h NOEL, LOEL, and EL50 were each reported as > 100 mg/L.

Description of key information

The key study was a static acute invertebrate toxicity test on the effects of HOSTAGEL HT 300 on the freshwater invertebrate Daphnia magna following OECD Guideline 202. The test substance did not induce acute immobilisation of Daphnia magna in the Water Accommodated Fraction (WAF) with a nominal loading of 100 mg/L. The 48-h NOEL, 48-h LOEL, and 48-h EL₅₀ were each reported as > 100 mg/L.  

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L