Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no data available: testing technically not feasible

Marine water

Hazard assessment conclusion:
no data available: testing technically not feasible

STP

Hazard assessment conclusion:
no data available: testing technically not feasible

Sediment (freshwater)

Hazard assessment conclusion:
no data available: testing technically not feasible

Sediment (marine water)

Hazard assessment conclusion:
no data available: testing technically not feasible

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no data available: testing technically not feasible

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

2 -EHDPP hydrolyzes rapidly (1 -12 hr) half-life and therefore the CSA will evaluate its primary hydrolysis products - phenol and 2-ethylhexanol.

Phenol PNECs

Upon hydrolysis, one mole of 2 -EHDPP produces two moles of phenol. As such, it is the primary hydrolysis product for 2 -EHDPP. Phenol is well studied and reviewed.  There are established PNECs in the published risk assessment report (ECB 2006 Phenol Risk Assessment).

PNECaqua= 7.7 μg/l (ECB 2006 Phenol Risk Assessment)

PNECmicroorganism= 2.1 mg/l (ECB 2006 Phenol Risk Assessment)

PNECsoil= 136 μg/kg dry weight (ECB 2006 Phenol Risk Assessment)

PNECsediment =115.6 mg/kg dw (ECB 2006 Phenol Risk Assessment)

 

2 -Ethylhexanol PNECs

Upon hydrolysis, one mole 2 -EHDPP produces one mole of 2-ethylhexanol, which is separately registered under REACH and the details on the PNEC are below:

Substance: 203 -234 -3 / 104 -76 -7 / 2 -ethylhexanol

PNEC aqua (freshwater) in 0.017 mg/L

Assessment factor: 1000

Extrapolation method: assessment factor

PNEC aqua (marine waters) in 0.0017mg/L

Assessmentfactor:10,000

Extrapolationmethod:assessment factor

 

PNEC aqua (intermittent releases) in 0.17 mg/L

Assessment factor - 100

Extrapolation method - assessment factor

PNEC STP in 10.0 mg/L

Assessment factor - 10

Extrapolation method - assessment factor

The PNEC for sewage treatment plant was determined using the NOEC for an STP inoculum from a ready

biodegradation test.

 

PNEC sediment in 0.28 mg/kg sediment dw

Extrapolation method - partition coefficient

PNEC soil in 0.047 mg/kg soil dw

Extrapolation method - partition coefficient

PNEC oral in 55 mg/kg food

Assessment factor - 30

Phosphorous Acid

Phosphorous acid is also a hydrolysis product of 2 -EHDPP; one mole of 2 -EHDPP produces one mole of phosphorous acid. Since the element phosphorous is an essential plant nutrient and phosphorous acid and its salts have low relatively low plant, animal and human toxicity, it appears that phosphorous acid will not have a significant impact on the environmental assessment of 2 -EHDPP. As such, the environmental assessment has focused on phenol and 2 -ethylhexanol.

Conclusion on classification

Update 2015

Diphenyl 2-ethylhexyl phosphitePhosphite

Composition: multiconstituent substance with 2 moles phenyl to 1 mole 2 -ethylhexanol, contains ~ 10 -20% TPP

Maximum theoretical hydrolysis yield: ~55% phenol

 Phenol classification was recently updated as a consequence of the CLP rules

TPP content

Although the Annex VI classification of TPP may be contested on the basis of the phenol content and the rapid hydrolysis, the registrant has updated the classification of this phosphite to H411 on the basis of the TPP content

This is derived from <25% of TPP

Current CLP Environmental Classification:

None

 

Proposed Change:

H411 – Aquatic Chronic 2

Based on new classification of H411 for phenol, which is predominant hydrolysis product. Note that this classification would also address the fact that the substance contains approximately 15% TPP.