Registration Dossier

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
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
NOAEL
DNEL value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
DNEL value:
1 762.5 mg/m³
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)
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
DNEL value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
5 000 mg/kg bw/day
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
166.7 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
30
Dose descriptor:
other: LOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
166.7 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:
low hazard (no threshold derived)

Additional information - workers

Substance Class/Read-Across Justification

Tris 2 -propylheptyl phosphite (T2PHP) is one of several structurally related tris alkyl phosphites. Alkyl phosphites are characterized by a phosphorus atom connected to three alkyl ester groups (oxygen connected to an alkyl chain). The closest alkyl phosphite structural analog to T2PHP is triisodecyl phosphite (TDP). Like T2PHP, the alkyl groups on TDP are branched,C10, isomers. TDP has an existing OECD 422 study. The NOAELs in this assessment are based on the TDP OECD 422 study (Tyl 2005)

Relationship Between Alkyl Phosphites and Alkyl Alcohols

These alkyl phosphites are manufactured using a class of alkyl alcohols that have been well studied and previously accepted as a category (Long Chain Alcohols Category under the OECD SIDS program; Alkyl Alcohols C6 to C13 Category under the U. S. High Production Volume (HPV) program). The category assessment and associated use of read-across data for these alkyl alcohols is particularly relevant for the alkyl phosphites because these phosphites readily hydrolyze into the associated alcohol used in the manufacture of the phosphite – TDP to isodecanol (C10) and T2PHP to 2 -propylheptanol (C10). Given this, it appears appropriate to consider both the category approach that was used to assess the alkyl alcohols under REACH as well as the data on the relevant alcohols as analogs to T2PHP and the related phosphites.

Acute DNELs

There were no signs of acute toxicity by either the oral, inhalation or dermal routes. As such, it is not necessary or appropriate to establish acute DNELs.

Dermal Local DNELs

TDP test positive in an LLNA skin sensitisation study. The EC3 concentration was 20%. The DNEL has derived as follows:

DNEL = EC3[%] * 250 [µg/cm²/%] / AF = 20% * 250 µg/cm²/% / 30 = 166.7 µg/cm²

Long-Term Systemic DNELs

The basis for the long-term systemic DNELs is the NOAEL of 1000 mg/kg/day (top dose) from the Tyl (2005) oral gavage combined repeat-dose and reproductive/developmental study in rats. 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:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

Additional information - General Population