Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Several reliable (Klimisch 1 or 2) toxicity studies in fish, invertebrates, and algae have been conducted using DMDMH or the hydrolysis product of DMDMH (DMH) and are included in this dossier. DMDMH readily undergoes hydrolysis to DMH and therefore data is provided for both substances where available. In the case of long-term testing, the data on DMH is considered more relevant for environmental fate and ecotoxicology and are considered in this dossier. These Key studies are summarized below.  There were no reliable toxicity data for aquatic plants; however, a waiver is being applied for this endpoint. 

Adequate reliable measured data exists for short-term toxicity to fish exposed to the test substance DMDMH within this dossier. The most sensitive reliable study result has been identified as a study (Ciliutti 2003) which reports an LC50 for short-term toxicity in fish of >82.3 mg/L. Consequently this value will be taken as the short-term toxicity in fish endpoint for DMDMH.

 

No reliable (Klimisch 1 or 2) long-term toxicity studies with fish have been conducted for DMDMH, although a reliable (Klimisch 1) long-term toxicity study with fish using DMH is included in this dossier. The study (Holmes & Swigert 1993) provides an estimated NOEC of 14 mg/L based on growth. Consequently this value will be taken as the long-term toxicity in fish endpoint for DMDMH. 

 

Reliable (Klimisch 1 or 2) short-term toxicity studies with invertebrates have been conducted for DMDMH and its hydrolysis products and are included in this dossier. As a conservative approach, the most sensitive result across these substances has been taken as the endpoint for DMDMH. The key study, Ciliutti (2003), provides a 48-hr EC50 of 29.1 mg/L for Daphnia magna. Consequently this value will be taken as the short-term toxicity in aquatic invertebrate endpoint for DMDMH.

 

No reliable (Klimisch 1 or 2) long-term toxicity studies with invertebrates have been conducted for DMDMH, although a reliable (Klimisch 1) long-term toxicity study with invertebrates using DMH is included in this dossier. The study (Zelinka et al., 1993) provides an estimated NOEC of 70.9 mg/L based on reproduction and mortality. Consequently this value will be taken as the long-term toxicity in invertebrates endpoint for DMDMH. 

 

Reliable (Klimisch 1) toxicity studies with algae have been conducted for DMDMH and DMH, the hydrolysis product of DMDMH and are included in this dossier. The study Vryenhoef & Mullee (2007) provides an estimated 72hr EC50 of 11 mg/L and 72hr NOEC of 5.1 mg/L, based on growth using DMDMH. Consequently this value will be taken as the toxicity in algae endpoint for DMDMH. 

 

Reliable (Klimisch 1) toxicity studies with microorganisms have been conducted for DMDMH and DMH, the hydrolysis product of DMDMH and are included in this dossier. The study Ciliutti (2003) provides an estimated 72hr EC50 of >100 mg/L and the NOEC was 100 mg/L based on growth using DMDMH. Consequently this value will be taken as the toxicity in microorganisms endpoint for DMDMH.