Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.043 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.098 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.004 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

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

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.573 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 with1,4-BDDMA and the structurally related substance 1,3-BDDMA 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. Algae were the most sensitive trophic level in acute and chronic studies.

The PNEC aqua (freshwater) was based on the EC10 of 4.35 mg/L determined in an algal toxicity study with Desmodesmus subspicatus.

Two chronic study results are available for this substance, which cover two trophic levels (algae and invertebrates), but only one (algae) is based on the the most sensitive species since daphnia magna proved to be the fewest sensitive species of the three trophic levels. Fish chronic data are not available. Therefore an assessment factor of 100 was applied to the EC10 (algae) 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 4.35 mg/L determined in an algal toxicity study with Desmodesmus subspicatus. An assessment factor of 1000 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 9.97 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

In an OECD guideline 310 biodegradation test including a toxicity control 20 mg/L of 1,4-BDDMA did not inhibit microbial activity. PNEC STP was derived using an assessment factor of 1 applied to the test concentration at which no toxicity to the inoculum was observed in the toxicity control of the ready biodegradation tests (20 mg/L) and in read across with 1,3 -BDDMA tested in a Bringman Kühn test with pseudomonas putida at a concentration of 51.2 g/l which is above the water solubilty of the substance.

 

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]

226.27

Melting point [°C]

-23.00

Boiling point [°C]

 

Vapour pressure [hPa], 20°C

0.001

Water solubility [mg/L], 20°C

243

Log Kow

3.10

Koc (Kow method)

322.6

PNEC aqua, freshwater[mg/L]

0.0435

PNEC aqua, marine [mg/L]

0.00435

 

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]

226.27

Melting point [°C]

-23.00

Boiling point [°C]

 

Vapour pressure [hPa], 20°C

0.001

Water solubility [mg/L], 20°C

243

Log Kow

3.10

Koc (Kow method)

322.6

PNEC aqua, freshwater[mg/L]

0.0435

 

PNEC oral

A PNEC oral was not calculated for 1,4-BDDMA since the substance is readily biodegradable. The probability of being rapidly metabolised in exposed organisms is high. Together with the reported log Kow was 3.1 this indicates that there would be only little 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, daphnia and algae are >1 mg/L and the substance is readily biodegradable. 1,4 -BDDMA does not need to be classified for acute toxicity to aquatic organisms according to 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 1,4-BDDMA is readily biodegradable. Thus, 1,4 -BDDMA does not need to be classified for chronic toxicity to aquatic organisms according to Regulation EC No 1272/2008.