Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
1.012 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.101 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
9 000 mg/L
Assessment factor:
1
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
3.67 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.367 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.14 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

PNEC aqua (freshwater)

Freshwater aquatic toxicity studies with MAPTAC were conducted in fish, invertebrates, and algal species. Acute toxicity studies were conducted in fish and algae. Chronic studies are available for algae and invertebrates. Aquatic invertebrates were the most sensitive trophic level in chronic studies.

The PNEC aqua (freshwater) was based on the EC10 of 50.6 mg/L determined in a 21 d reproduction study with Daphnia magna. Two chronic studies were available for this substance, which covered two trophic levels (algal and invertebrates). Since similar short-term toxicity was observed between trophic levels with all L(E)C50 values in a similar range, an assessment factor of 50 was applied to the EC10 to calculate the PNEC aqua (freshwater) in accordance with Guidance on information requirements and chemical safety assessment, Chapter R.10: Characterisation of dose [concentration]-response for environment, 2008.

 

PNEC aqua (marine)

No tests with marine species are available. The PNEC aqua (marine) was based on the EC10 of 50.6 mg/L determined in a 21 d reproductions study with Daphnia magna. An assessment factor of 500 was applied to the EC10 to calculate the PNEC aqua (marine) in accordance with Guidance on information requirements and chemical safety assessment, Chapter R.10: Characterisation of dose [concentration]-response for environment, 2008. 

 

PNEC aqua (intermittent release)

The PNEC aqua (intermittent release) was based on the lowest acute toxicity value of 100 mg/L for Desmodesmus subspicatus (72 h EC50). Based on the available data set, an assessment factor of 100 was applied to the lowest EC50 to calculate the PNEC aqua (intermittent release) in accordance with Guidance on information requirements and chemical safety assessment, Chapter R.10: Characterisation of dose [concentration]-response for environment, 2008..

 

PNEC STP

The PNEC STP was based on the 16 h EC10 of 9000 mg/L in a Bringman-Kühn test in Pseudomonas putida. Based on the available data, an assessment factor of 1 was applied to calculate the PNEC STP in accordance with Guidance on information requirements and chemical safety assessment, Chapter R.10: Characterisation of dose [concentration]-response for environment, 2008..

  

PNEC sediment (freshwater, marine)

No toxicity data for sediment dwelling organisms are available. Thus, the PNEC for freshwater as well as marine sediment has been calculated with the equilibrium partitioning method using EUSES 2.1.

The following data have been taken into account for the calculation:

Molecular weight [g/mol]

220.74

Melting point [°C]

54.00

Boiling point [°C]

 

Vapour pressure [Pa], 25°C

0.001

Water solubility [mg/L], 20°C

1000000000

Log Kow

-2.58

Koc (Kow method)

0.2428

PNEC aqua, freshwater[mg/L]

1.012

PNEC aqua, marine [mg/L]

0.1012

 

PNEC soil

No toxicity data for soil organisms are available. Thus, the PNEC for freshwater as well as marine sediment has been calculated with the equilibrium partitioning method using EUSES 2.1.

The following data have been taken into account for the calculation:

Molecular weight [g/mol]

220.74

Melting point [°C]

54.00

Boiling point [°C]

 

Vapour pressure [Pa], 25°C

0.001

Water solubility [mg/L], 20°C

1000000000

Log Kow

-2.58

Koc (Kow method)

0.2428

PNEC aqua, freshwater[mg/L]

1.012

 

PNEC oral

A PNEC oral was not calculated for MAPTAC due to the calculated log Kow of -2.58 indicating that there would be only little or no biomagnification of the test substance in the food chain.

Conclusion on classification

Based on the available reliable and relevant data, short-term toxicity values (L(E)C50) for fish and algae are >1 mg/L. MAPTACdoes not need to be classified for acute toxicity to aquatic organisms according to Directive 67/548/EEC or Regulation EC No 1272/2008.

 

Based on the available reliable and relevant data, long-term toxicity values (EC10) for aquatic invertebrates and algae are > 1 mg/L, and MAPTAC is not readily biodegradable (inherently biodegradble). Thus, MAPTACdoes not need to be classified for chronic toxicity to aquatic organisms according to Regulation EC No 1272/2008.

No classification for chronic toxicity to aquatic organisms according to Directive 67/548/EEC is required based on the available short-term toxicity values (> 100 mg/L) and inherent biodegradability.