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Short-term toxicity to fish

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Description of key information

The acute toxicity of the read-across substance Guanidine Nitrate was tested in a 96-h toxicity test against Ictalurus punctatus (Channel catfish), Pimephales promelas (Fathead minnow) and Leuciscus idus (Goldorfe). The 96-h-LC50 was reported as 690 mg a.i./L in the toxicity test against Pimerphales promelas. 

Key value for chemical safety assessment

LC50 for freshwater fish:
690 mg/L

Additional information

The acute toxicity of Guanidine Chloride was teste with Leuciscus idus according to DIN 28412 L15 for 48h. The 48h-LC50 was determined to be 1,758 mg/l a.i. As the test duration was less than 96h, instead the result from the 96h -test with the read-across substance Guanidine nitrate was used.

The acute toxicity of the read-across substance Guanidine Nitrate was tested in toxicity tests against Ictalurus punctatus (Channel catfish), Pimephales promelas (Fathead minnow) peer-reviewed by van der Schalie (1985) and Leuciscus idus (Goldorfe) reported by Adema (1988).

In contrast to OECD Guideline 203 and the recommendation in REACH Guideline R.7.b, the test duration was only 48hours in the study of Adema (1988). Nethertheless both studies together are significant. In the study of Adema (1988) a 48-h-LC50 of 2420mg a.i.mg/L was reported whereas in the study of van der Schalie (1989) two results of Rohr (1984) were peer-reiewed with an 96 -h-LC50 of 690 mg/L when testing Pimephales promelas and an 96 -h-LC50 of 1850mg/L when testing Ictalurus punctatus.

Justification for read-across:

Guanidine hydrochloride and guanidine nitrate dissociate in aqueous media to yield the guanidine ion and the respective anion. Therefore it is reasonable to discuss the effects of the ions separately. The chloride ion is a naturally occurring essential ion in human beings with well-known metabolism and mechanisms of action as described in standard textbooks on pharmacology and physiology. As well it is found as salt in the Earth´s crust and is dissolved in seawater. Effects of guanidine hydrochloride are expected to be based primarily on the guanidine ion. The physiological processing of the guanidine ion is expected to be independent of the individual source. Therefore read-across from guanidine hydrochloride for effects of guanidine dissociated from guanidine nitrate is considered valid. This strategy is supported by a quite similar toxicological profile of both substances, as shown in acute toxicity, irritation, sensitization and genotoxic studies.

A more detailed justification is attached and outlined in CSR chapter 1.1.2 as well.