Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: 905-728-0 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.06 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Explanation for the modification of the dose descriptor starting point:
- Effects are systemic. Given the limited volatility, oral dosing would be much higher than inhalation.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Explanation for the modification of the dose descriptor starting point:
- Dermal penetration of substance is expected to be low, oral route gives greatest systemic dose.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 11.7 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 30
- Dose descriptor:
- other: EC3
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 11.7 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 30
- Dose descriptor starting point:
- other: EC3
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
2-Ethylhexyl diphenyl phosphite (2-EHDPP) is a member of the phenyl/alkyl class of phosphites of which there are a number of related commercial phosphites including triphenyl phosphite (TPP), diphenyl isodecyl phosphite (DPDP), diisodecyl phenyl phosphite (DDPP), and triisodecyl phosphite (TDP). This class of phosphite shares several similarities in terms of physicochemical characteristics, including very low vapour pressure, very low water solubility, and rapid hydrolysis into corresponding alcohols (e.g. phenol, 2-ethylhexanol) and phosphorous acid. Given this rapid hydrolysis, these phosphite substances cannot be tested effectively in water and, as such, the aquatic/environmental assessment is based on evaluating the hydrolysis products. The mammalian toxicity of this class of phosphites varies somewhat with TPP being the most toxic and the tris alkyl phosphites (e.g. TDP) being the least toxic. There is some data, including comparable acute toxicity data, for the diphenyl alkyl phosphites (e.g. 2-EHDPP and DPDP) that suggests that they are less toxic than TPP. However, for several endpoints including repeat-dose toxicity and reproductive and developmental toxicity TPP data is being used to address the data requirements for 2-EHDPP. This is likely to present a conservative or worst-case assessment of the health hazards for those endpoints. Additional data on DPDP is also being considered for the toxicology assessment of 2-EHDPP. DPDP and 2-EHDPP are expected to have similar toxicities given they are both diphenyl phosphites and the phenyl groups’ toxicity is expected to dominate that of the alkyl group.
Acute Systemic Effects
2 -EHDPP has a low order of acute toxicity and no specific acute systemic hazard has been identified. As such, a DNEL for acute toxicity is unnecessary as the long-term DNEL will be sufficient to ensure that adverse effects do not occur. Consequently, no worker-DNELs for acute toxicity have been calculated.
DNEL for Dermal Local Effect
2 -EHDPP is expected to be a skin sensitiser. A conservative local dermal DNEL has been derived using the LLNA EC3 of 1.4% from a study of TPP (Harlan 2010). The same DNEL is provided for both acute and long-term exposure. 2 -EHDPP will be classified as a skin sensitiser, so dermal exposure to the worker should be minimal due to dermal PPE (e.g., gloves). Basis for DNEL is as follows:
DNEL = EC3[%] * 250 [µg/cm²/%] / AF = 1.4% * 250 µg/cm²/% / 30 = 11.7 µg/cm²
DNELS for Long-Term Systemic Effects
The basis for the systemic DNELs is the NOAEL of 15 mg/kg/day (rats) from the TPP repeat dose toxicity study (Tyl 2004).
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.53 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEC
- Explanation for the modification of the dose descriptor starting point:
- Effects are systemic. Given the limited volatility, oral dosing would be much higher than inhalation.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.75 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Explanation for the modification of the dose descriptor starting point:
- Dermal penetration of substance is expected to be low, oral route gives greatest systemic dose.
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 11.7 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- Overall assessment factor (AF):
- 30
- Dose descriptor:
- other: EC3
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 11.7 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- Overall assessment factor (AF):
- 30
- Dose descriptor starting point:
- other: EC3
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 75 µg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
2-Ethylhexyl diphenyl phosphite (2-EHDPP) is a member of the phenyl/alkyl class of phosphites of which there are a number of related commercial phosphites including triphenyl phosphite (TPP), diphenyl isodecyl phosphite (DPDP), diisodecyl phenyl phosphite (DDPP), and triisodecyl phosphite (TDP). This class of phosphite shares several similarities in terms of physicochemical characteristics, including very low vapour pressure, very low water solubility, and rapid hydrolysis into corresponding alcohols (e.g. phenol, 2-ethylhexanol) and phosphorous acid. Given this rapid hydrolysis, these phosphite substances cannot be tested effectively in water and, as such, the aquatic/environmental assessment is based on evaluating the hydrolysis products. The mammalian toxicity of this class of phosphites varies somewhat with TPP being the most toxic and the tris alkyl phosphites (e.g. TDP) being the least toxic. There is some data, including comparable acute toxicity data, for the diphenyl alkyl phosphites (e.g. 2-EHDPP and DPDP) that suggests that they are less toxic than TPP. However, for several endpoints including repeat-dose toxicity and reproductive and developmental toxicity TPP data is being used to address the data requirements for 2-EHDPP. This is likely to present a conservative or worst-case assessment of the health hazards for those endpoints. Additional data on DPDP is also being considered for the toxicology assessment of 2-EHDPP. DPDP and 2-EHDPP are expected to have similar toxicities given they are both diphenyl phosphites and the phenyl groups’ toxicity is expected to dominate that of the alkyl group.
Acute Systemic Effects
2 -EHDPP has a low order of acute toxicity and no specific acute systemic hazard has beenidentified. As such, a DNEL for acute toxicity is unnecessary as the long-term DNEL will be sufficient to ensure that adverse effects do not occur. Consequently, no worker-DNELs for acute toxicity have been calculated.
DNEL for Dermal Local Effect
2 -EHDPP is expected to be a skin sensitiser. A conservative local dermal DNEL has been derived using the LLNA EC3 of 1.4% from a study of TPP (Harlan 2010). The same DNEL is provided for both acute and long-term exposure. 2 -EHDPP will be classified as a skin sensitiser, so dermal exposure to the worker should be minimal due to dermal PPE (e.g., gloves). Basis for DNEL is as follows:
DNEL = EC3[%] * 250 [µg/cm²/%] / AF = 1.4% * 250 µg/cm²/% / 30 = 11.7 µg/cm²
DNELS for Long-Term Systemic Effects
The basis for the systemic DNELs is the NOAEL of 15 mg/kg/day (rats) from the TPP repeat dose toxicity study (Tyl 2004).
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