Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.822 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other:
Overall assessment factor (AF):
225
Dose descriptor starting point:
LOAEL
Value:
150 mg/kg bw/day
Modified dose descriptor starting point:
LOAEC
Value:
185 mg/m³
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
3
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
6
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
1
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
5
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
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:
0.833 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other:
Overall assessment factor (AF):
900
Dose descriptor starting point:
LOAEL
Value:
150 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
750 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
3
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
6
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
5
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
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:
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: EC3
Value:
5 000
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
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
30
Dose descriptor starting point:
other: EC3
Value:
5 000

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Substance Class Overview


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 analogue to T2PHP is triisodecyl phosphite (TDP). Like T2PHP, the alkyl groups on TDP are branched C10 isomers.  Another close analogue is Triisotridecyl phosphite (TiTDP); the alkyl group on TiTDP are branched C13 isomers. Here are the key studies for these chemicals:



  • T2PHP: OECD 422 guideline GLP study, rat, oral gavage (JRF, 2022)

  • TDP: OECD 422 guideline GLP study, rat, oral gavage - extended exposure (RTI 2005)

  • TiTDP: OECD 408 90-Day guideline GLP study, rat, oral gavage (JRF 2019)

  • TiTDP: 90-Day GLP repeated dose toxicity, rat, oral gavage, male only (LabCorp 2022)

  • TiTDP: (2) OECD 414 Prenatal developmental toxicity, rat, oral gavage (JRF 2018 and 2021)


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 hydrolyse into the associated alcohol used in the manufacture of the phosphite – TDP to isodecanol (C10), T2PHP to 2 -propylheptanol (C10), and TiTDP to isotridecyl alcohol. Data on these alkyl alcohols provides additional information for the assessment of alkyl phosphites and also supports the concept of the alkyl phosphites being close analogues. 


Acute DNELs


There were no signs of acute toxicity by either the oral, inhalation or dermal routes for TDP, nor acute oral toxicity observed for TiTDP. As such, it has been concluded that T2PHP is not acutely toxic and therefore 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%. These results are being read across to T2PHP. 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


There are several points of departure to consider for the long-term systemic DNELs for T2PHP. In the OECD 422 study on T2PHP there was a LOEL of 150 mg/kg/day for systemic toxicity (the effects observed could not be determined definitively to be adaptive or adverse) and a NOAEL of 450 mg/kg/day for reproductive and developmental toxicity and neurotoxicity. For TDP, the NOAEL is 1000 mg/kg/day (top dose) for repeat-dose, reproductive and developmental toxicity and neurotoxicity.  For TiTDP, the subchronic NOAEL is 375 mg/kg/day and the developmental toxicity NOAEL is 1000 mg/kg/day.


The most conservative DNELs were derived using the LOEL of 150 mg/kg/day from the T2PHP OECD 422 study. It should be noted that while this is not a LOAEL value, it was treated as such in the DNEL calculations. This approach to deriving these DNELs should in no way be construed as considering the effects from this study to be adverse. 


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:
0.145 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other:
Overall assessment factor (AF):
450
Dose descriptor starting point:
LOAEL
Value:
150 mg/kg bw/day
Modified dose descriptor starting point:
LOAEC
Value:
65.3 mg/m³
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
3
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
6
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
1
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
10
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
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:
0.417 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other:
Overall assessment factor (AF):
1 800
Dose descriptor starting point:
LOAEL
Value:
150 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
750 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
3
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
6
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
10
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
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:
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: EC3
Value:
5 000
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
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
30
Dose descriptor starting point:
other: EC3
Value:
5 000

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
83.3 µg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other:
Overall assessment factor (AF):
1 800
Dose descriptor starting point:
LOAEL
Value:
150 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
150 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
3
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
6
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
10
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
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

See discussion under Additional Information - Workers