Registration Dossier
Registration Dossier
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EC number: 202-908-4 | CAS number: 101-02-0
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.53 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 26.45 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Corrected inhalation NOAEL = oral NOAEL x (1/sRVrat)[1]x (ABSoral-rat/ ABSinhl-human)
= 15 mg/kg/day x (1 / 0.38m3kg-18hr-1) x (1/1)[2]
Corrected inhalation NOAEL = 39.47 mg/m3for 8hr
Corrected Inhalation NOAEL (workers) = 39.47 x (sRVhuman/ wRV)[3]
= 39.47 x (6.7 / 10)
Corrected Inhalation NOAEL (workers) = 26.45 mg/m3for 8hr
[1]Standard respiratory volume (rat) = 0.38 m3/kg for 8 hours.
[2]Inhalation absorption in humans is equal to the oral absorption in rats (both assumed to be 100%).
[3]Standard respiratory volume (human) = 6.7 m3for 8 hours; worker respiratory volume = 10 m3for 8 hours.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- Justification:
- Standard AF for subchronic to chronic. The fact that the duration of exposure (70 days) is less than 90 days has been addressed with the database AF.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Already addressed in dose conversion.
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard AF.
- AF for intraspecies differences:
- 5
- Justification:
- Standard AF.
- AF for the quality of the whole database:
- 2
- Justification:
- An additional factor is being added to address the fact that the repeat-dose exposures are 70 days, less than standard 90 days exposures for this endpoint.
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:
- 0.15 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No dermal repeated-dose studies are available. Route-to-route extrapolation was therefore used to convert the NOAEL identified in an oral study in rats (15 mg/kg/d) to an equivalent dermal NOAEL. To convert the oral NOAEL to a dermal NOAEL, the registrants assumed an oral absorption of 100% in rats and a dermal absorption of 50% in humans.
Corrected dermal NOAEL = oral NOAEL x (ABSoral-rat/ ABSdermal-human)
= 15 mg/kg/day x (1/0.5)
Corrected dermal NOAEL = 30 mg/kg/day
Whilst there is no specific measured information on TPP dermal absorption, there is quite a bit of information on dermal absorption as it relates to Kow. At a log Kow of 6.6, TPP’s dermal absorption would be expected to be very low. We believe assuming even 50% dermal absorption is a very conservative assumption for TPP given the guidance and literature on this endpoint. ECHA considers a default of 10% dermal absorption for substances with a log Kow >4 and the NIOSH dermal absorption model does not consider dermal absorption relavant for chemicals with log Kow >5.
The likelihood of systemic exposure from dermal exposure to TPP is further lowered by the localised skin effects, which will limit contact time and skin expsoure.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- Justification:
- Standard AF for subchronic to chronic. The fact that the duration of exposure (70 days) is less than 90 days has been addressed with the database AF.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Standard AF
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard AF
- AF for intraspecies differences:
- 5
- Justification:
- Standard AF
- AF for the quality of the whole database:
- 2
- Justification:
- An additional factor is being added to address the fact that the repeat-dose exposures are 70 days, less than standard 90 days exposures for this endpoint.
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:
- 11.7 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- Overall assessment factor (AF):
- 30
- Dose descriptor:
- other: LOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 11.7 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:
- medium hazard (no threshold derived)
Additional information - workers
Acute Systemic Effects
TPP has a lower order of acute toxicity compared to the repeat-dose study. As such, a DNEL for acute toxicity is unnecessary as the long-term DNEL will be sufficient to ensure that adverse effects do not occur. Consequently, no worker-DNELs for acute toxicity have been calculated.
DNEL for Dermal Local Effect
The basis for the local dermal DNEL is the LLNA EC3 of 1.4% (Harlan 2010). The same DNEL is provided for both acute and long-term exposure. TPP will be classified as skin irritant and a skin sensitiser, so dermal exposure to the worker should be minimal due to dermal PPE (e.g., gloves). Basis for DNEL is as follows:
DNEL = EC3[%] * 250 [µg/cm²/%] / AF = 1.4% * 250 µg/cm²/% / 30 = 11.7 µg/cm²
DNELS for Long-Term Systemic Effects
The basis for the systemic DNELs is the NOAEL of 15 mg/kg/day (rats) from the repeat dose toxicity study (Tyl 2004).
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
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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