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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
70.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
1 762.5 mg/m³
Explanation for the modification of the dose descriptor starting point:

Extrapolated from oral toxicity study.  Substance's vapor pressure is too low to test via inhalation. Default assessment factors.

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:
50 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
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
5 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Key Study: RTI Modified OECD 422 Design of TDP (Tyl 2005), Oral (gavage) exposure in rats

 

Dose Descriptor: NOAEL (systemic toxicity) = 1,000 mg/kg/day

 

Corrected Dermal NOAEL = Oral NOAEL x (ABSoral-rat/ ABSdermal-human)

 

= 1000 mg/kg/day x (5)[1]

 

Corrected Dermal NOAEL = 5000 mg/kg/day

 

Assessment Factors:  Interspecies               4 (allometric scaling)

                                                                       2.5 (remaining differences)

                                   Intraspecies                5 (REACH guidance)

                                   Exposure Duration     2 (subchronic to chronic)

                                   Dose Response           1

                                   Quality of Database   1

 

Total Assessment Factor:                              100

 

DNELDermal - Long-Term Systemic= 5000 mg/kg/day ÷ 100

 

DNELDermal - Long-Term Systemic= 50.0 mg/kg/day


[1] Extrapolated from oral study (assume 50% oral and 10% dermal absorption)

AF for dose response relationship:
1
AF for differences in duration of exposure:
2
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
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:
338.33 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
30
Dose descriptor:
other: LOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
338.33 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
Overall assessment factor (AF):
30
Dose descriptor starting point:
other: LOAEL

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Acute Effects

PDDP is demonstrated to have a low order of acute toxicity. DNELs for acute systemic toxicity should only be derived if an acute toxicity hazard, leading to classification and labelling (e.g. under EU CLP or DSD regulations), has been identified and there is a potential for high peak exposures (this is only usually relevant for inhalation exposures). As no acute hazard has been identified, then a DNEL for acute toxicity is unnecessary as the long-term DNEL will normally be sufficient to ensure that adverse effects do not occur. Consequently, no worker-DNELs for acute toxicity have been calculated.

Sensitisation

PDDP is a skin sensitiser. As such, a DNEL for localised dermal effects has been established.

The basis for the local dermal DNEL is the LLNA EC3 of 40.6% (Harlan 2010) using the scaling equation provided by ECHA:

EC3[%] * 250 [µg/cm²/%] = EC3 [µg/cm²]

Given that PDDP will be classified as skin irritant and a skin sensitiser, dermal exposure to the worker should be minimal due to dermal PPE (e.g., gloves).

PDDP has a very low vapour pressure and respiratory exposure is not anticipated to occur to any significance.

Derivation of the Systemic DNELs

The basis for the systemic DNELs is the NOAEL of 1000 mg/kg/day (rats) from the repeat dose toxicity study of triisodecyl phosphite (TDP) (Tyl 2005). TDP is a constituent of commercial PDDP and a structural analog to the other constituents, so these data can be appropriately applied to PDDP. This selection of NOAEL is further supported by the repeat-dose NOAEL of 1000 mg/kg/day of PDDP in a neurotoxicity study in hens. The inhalation and dermal DNELs were extrapolated from the oral study using standard route-to-route extrapolations and assuming 50% oral and inhalation absorption and 10% dermal absorption.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
35 mg/m³
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
1 765 mg/m³
Explanation for the modification of the dose descriptor starting point:

Extrapolated from oral toxicity study.  Substance's vapor pressure is too low to test via inhalation. Default assessment factors.

Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
25 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
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
5 000 mg/kg bw/day
AF for differences in duration of exposure:
2
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

Based on use patterns and chemical characteristics exposure to the general population is not expected to be significant.