Registration Dossier
Registration Dossier
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EC number: 246-998-3 | CAS number: 25448-25-3
Toxicological Summary
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
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- 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
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- 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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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