Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Short-term toxicity to fish:

The toxicity of N,N-dimethylacetamide to fish was investigated in a static test conducted according to DIN 38412, part 15 using Leuciscus idus as test organism (BASF AG, 1979; report no. 78/277). Based on nominal test concentrations the 96-h LC50 was found to be >500 mg/L. These data were selected as key data in terms of the chemical safety assessment.

In conclusion, N,N-dimethylacetamide (CAS 127-19-5) is concluded to be with high probability acutely not harmful to fish.

 

Long-term toxicity to fish:

No experimental data available.

In Annex IX section 9.1.6 of Regulation (EC) No 1907/2006, it is laid down that chronic tests 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 Regulation 1272/2008 or is assessed to be a PBT or vPvB. The hazard assessment of the substance reveals neither a need to classify the substance as dangerous to the environment, nor is it a PBT or vPvB substance, nor are there any further indications that the substance may be hazardous to the environment. Furthermore, the substance is readily biodegradable without fulfilling the 10-day window criterion but reaching official pass levels at the end of the test. Therefore, and for reasons of animal welfare a chronic test on fish is not provided.

 

Short-term toxicity to aquatic invertebrates:

Considering the toxicity of N,N-dimethylacetamide to aquatic invertebrates there are experimental data from two studies for each, the freshwater and marine compartment available.

Freshwater data:

- In a static test conducted according to EU method C.2., using D. magna as test organism, a 48-h EC50 of >500 mg/L was determined, based on nominal test concentrations (BASF AG, 1988; report no. 1/1021/2/88-1021/88). These data were selected as freshwater-key data.

- In a supporting acute toxicity test (guideline not specified in study report) with D. magna as test organism, the 48-h EC50 was >1000 g/L (nominal, Adema, 1987; cited in OECD SIDS, 2001).

Marine data:

- A semi-static acute toxicity test (guideline not specified in study report) was conducted using Americamysis bahia (former: Mysidopsis bahia) as test organism. Based on nominal test concentrations the 96-h EC50 was found to be 966 mg/L (Adema, 1987; cited in OECD SIDS, 2001). These data were selected as key-marine data.

 - In a further acute toxicity test conducted under marine conditions (guideline not specified in study report) the test organism was chaetogammarus marinus. After an exposure period of 96 h the EC50 was determined to be >1000 mg/L, supporting the results of the marine key study (Adema, 1987; cited in OECD SIDS, 2001).

In conclusion, the substance is assessed to be with probability acutely not harmful to aquatic invertebrates. 

 

Long-term toxicity to aquatic invertebrates:

No experimental data available.

In Annex IX section 9.1.5 of Regulation (EC) No 1907/2006, it is laid down that chronic tests shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on aquatic invertebrates. 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 Regulation 1272/2008 or is assessed to be a PBT or vPvB. The hazard assessment of the substance reveals neither a need to classify the substance as dangerous to the environment, nor is it a PBT or vPvB substance, nor are there any further indications that the substance may be hazardous to the environment. Furthermore, the substance is readily biodegradable without fulfilling the 10-day window criterion but reaching official pass levels at the end of the test. Therefore, a chronic test on aquatic invertebrates is not provided.

 

Toxicity to aquatic algae and cyanobacteria:

In a non-GLP, 72 -hour static test with the green algae Desmosdemus subspicatus according to a national standard method (German Industrial Standard DIN 38412, Part 9), the algal toxicity of N,N-dimethylacetamide was studied. The original data were statistically re-evaluated using Toxrat Pro v2.09. Based on growth rate an EC50 (72 h) of > 500 mg/L and a NOEC (72 h) of >= 500 mg/L were determined (BASF AG, 1989/2007. Report No. 2/1021/88) indicating the substance to be with high probability acutely not harmful to aquatic algae.

 

Toxicity to microorganisms:

The toxicity of N,N-dimethylacetamide (CAS 127-19-5) to microorganisms was investigated in a study conducted equivalent to OECD 209, but using activated sludge from an industrial wwtp. The 30-min EC10 was determined to be greater than 1995 mg/L based on the respiration rate (BASF AG, 1980; report no. 1168; cited in OECD SIDS, 2001). These data were selected as key data for the chemical safety assessment.

A further study was conducted with the single species Pseudomonas putida according to DIN 38412-27. A 16-h LOEC of 4850 mg/L could be determined, supporting the data of the key study. As the original report of this study is not available, the exposure duration was assumed to be 16 hours (BASF AG, 1986; report no. 312186; cited in OECD SIDS, 2001).

Based on the available experimental data, N,N-dimethylacetamide (CAS 127-19-5) is concluded to not inhibit the degradation activity of activated sludge when introduced in appropriately low concentrations.