Registration Dossier
Registration Dossier
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EC number: 235-841-4 | CAS number: 13003-12-8
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:
- 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
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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Substance Class/Read-Across Justification
Butylidenebis [2-Tert-Butyl-5-Methyl-P-Phenylene]-P,P,P`,P`-Tetratridecylbis(phosphine), commercially know as STAB AS-4500 or Doverphos (DP) 479, is a diphosphite that is combination of two alkyl phosphites with a bridging structure called BBMC. The alkyl phosphite portions of this substance are from isotridecyl phosphite (TiTDP) and thus it was determined that this substance can appropriately read-across to (TiTDP) and triisodecyl phosphite (TDP).
Alkyl phosphites are characterized by a phosphorus atom connected to two to three alkyl ester groups (oxygen connected to an alkyl chain). The alkyl groups on TDP are branched,C10, isomers and the alkyl groups on TiTDP are branched, C13, isomers. TDP has an existing OECD 422 study and TiTDP is currently undergoing sub-chronic (90 -day) testing. 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), TiTDP to isotridecanol (C13). 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 TiTDP, STAB AS-4500 and the related alkyl 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.
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:
- DNEL (Derived No Effect Level)
- Value:
- 35 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 762.5 mg/m³
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:
- 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/m³
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 5 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
50% oral absorption to 10% dermal absorption
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- no hazard identified
General Population - Hazard via oral route
Systemic 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 for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
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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