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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
1 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
482 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
no exposure of sediment expected

Sediment (marine water)

Hazard assessment conclusion:
no exposure of sediment expected

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no exposure of soil expected

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

PNEC aqua (freshwater)

 

Short-term toxicity tests are available on DEIPA in fish, invertebrates and algae, covering three trophic levels (predators, plant-eating animals, and primary producers, respectively). In good quality guideline studies, performed to GLP, LC50s in freshwater fish (Marino et al. 1999a), daphnia (Marino et al. 1999b) and algae (Kirk et al. 1999) were all above 100 mg/L [the highest tested concentration level]. As these studies show, DEIPA does not exhibit acute aquatic toxicity, even at high concentrations. Furthermore, DEIPA is a miscible liquid and is unlikely to pose a long-term toxicity risk to freshwater organisms. According to the REACH guidance on information requirements and chemical safety assessment (IR&CSA, Chapter R.10), an assessment factor (AF) of 1000 should be applied when at least one short-term LC50 from each of three trophic levels (fish, invertebrates (preferred Daphnia) and algae) is available (ECHA, 2008). The use of such an AF in this instance is very conservative, as the point-of-departure is not a LC50 (as no deaths were reported in any of the three studies) but rather a NOEC for mortality. The AF was therefore reduced to 100.

 

PNECaqua (freshwater) = 100 mg/L / 100 = 1 mg/L

 

 

PNEC aqua (marine water)

 

No toxicity studies were available on saltwater organisms. The PNEC aqua (marine water) is therefore based on the freshwater LC50s of more than 100 mg/L [the highest tested concentration level], as discussed above (Kirk et al. 1999; Marino et al. 1999a, 1999b). According to chapter R.10 of the IR&CSA, an AF of 10,000 should be applied to the lowest short-term LC50 from freshwater or saltwater representatives of three taxonomic groups (algae, crustaceans and fish) of three trophic levels (ECHA, 2008). The use of such an AF in this instance is very conservative, as the point-of-departure is not a LC50 (as no deaths reported in any of the three studies) but rather a NOEC for mortality. The AF was therefore reduced to 1000.

PNECaqua (marine water) = 100 mg/L / 1000 = 0.1 mg/L

PNEC aqua (intermittent releases)

 

A PNEC for intermittent releases was not calculated. According to chapter R.10 of the IR&CSA, these are required in cases where discharges, and therefore environmental exposure, are limited in time (ECHA, 2008). This is not the case for DEIPA – any environmental exposure (if it did occur) is assumed to be constant.

 

 

PNEC STP (sewage treatment plant)

 

Toxicity data available for the effects of DEIPA on bacteria, suggest that DEIPA is of low toxicity to microorganisms. The respiration of microorganisms in activated sludge from a municipal sewage treatment plant over three hours was unaffected by the presence of DEIPA at concentrations of up to 4820 mg/l (considered the 3-hr NOEC for this study) (Gonsior and Manor, 1999). Chapter R.10 of the IR&CSA suggests that an AF of 10 can be applied to the NOEC from a reliable respiration inhibition test in bacteria (ECHA, 2008).

 

PNECmicroorganisms = 4820 mg/L / 10 = 482 mg/L

 

 

PNEC sediment (freshwater) and PNEC sediment (marine water)

 

PNECS were not calculated for freshwater or marine sediment as exposure to these compartments is not anticipated.

 

 

PNEC air

 

No data were available on the possible effect of DEIPA on the atmosphere, but biotic and abiotic effects (e.g. global warming, ozone depletion, acidification) were considered unlikely because of its low volatility. Using the vapour pressure balance method (equivalent to the relevant OECD test guideline, and performed to GLP) DEIPA was seen to have a vapour pressure of 0.0084 Pa (Atwal, 2012). According to chapter R.7a of the IR&CSA, substances with vapour pressures below 0.01 Pa are “low volatility substances” (ECHA, 2012).

 

 

PNEC soil

 

A PNEC was not calculated for soil as exposure to this compartment is not anticipated.

 

           

PNEC oral (secondary poisoning)

 

A PNEC oral for secondary poisoning was not calculated. According to chapter R.8 of the IR&CSA, an assessment does not need to be conducted unless the substance has a log Kow of at least 3 or a BCF of at least 100, and there are no mitigating properties such as ready biodegradability or hydrolysis (with a half-life of less than 12 hours) (ECHA, 2011). Being readily biodegradable (and additionally having a low Log Kow value), DEIPA does not fulfil these criteria.

 

References

ECHA (2008). European Chemicals Agency. Guidance on information requirements and chemical safety assessment. Chapter R.10: Characterisation of dose [concentration]-response for environment. May 2008.http://echa.europa.eu/documents/10162/13632/information_requirements_r10_en.pdf

 

ECHA (2011). European Chemicals Agency. Guidance on information requirements and chemical safety assessment. Part B: Hazard assessment. Version 2.1. December 2011.

http://echa.europa.eu/documents/10162/13643/information_requirements_part_b_en.pdf

 

ECHA (2012). European Chemicals Agency. Guidance on information requirements and chemical safety assessment. Chapter R.7a: Endpoint specific guidance. Version 2.0. November 2012.http://echa.europa.eu/documents/10162/13632/information_requirements_r7a_en.pdf

Conclusion on classification

In accordance with Regulation (EC) No. 1272/2008 (CLP), a substance should be classified as an acute aquatic hazard if the 96-hr LC50 for fish, the 72- or 96-hr EC50 for algae, or the 48-hr EC50 for crustaceans is 1 mg/L or less. The acute toxicity (LC50/EC50) of DEIPA to aquatic species is >100 mg/L for all trophic levels (Kirk et al. 1999; Marino et al. 1999a, 1999b) and therefore does not require classification as an acute aquatic hazard under CLP.

Under CLP, substances should be classified as chronic aquatic hazards if any of the above criteria for acute aquatic hazard are fulfilled, and the substance is not rapidly degradable and/or the experimentally determined BCF is at least 500 (or, if the BCF is not available, the Log Kow is at least 4). DEIPA is readily biodegradable (Goodwin, 1999), and has a log Pow of -1.01 (Butler, 2012). DEIPA does not meet the criteria for classification as a chronic aquatic hazard under CLP.