Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.15 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):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 11.53 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Corrected NOAEC = Oral NOAEL * (1/sRV rat 8h) * (ABS oral-rat / ABS inh-human) * (sRV human 8h / wRV 8h) with oral NOAEL = 6.54 mg/kg bw/d; sRV rat 8h = 0.38 m3/kg bw; ABS oral rat = 100% **; ABS inh-human=100% ; sRV human 8h = 6.7 m3/person; wRV 8h = 10 m3/person. Corrected NOAEC = 11.53 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as the starting point
- AF for differences in duration of exposure:
- 2
- Justification:
- Sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling used in derivation of inhalation DNEL
- AF for other interspecies differences:
- 1
- Justification:
- Standard factor used for interspecies remaining differences is 2.5. Hepatotoxicity was observed in three species (rat, mouse and dog) treated with THPX substances in sub-acute, sub-chronic and chronic studies by oral route. Therefore, This AF is considered = 1. (See Table 1)
- AF for intraspecies differences:
- 5
- Justification:
- Default factor used for worker
- AF for the quality of the whole database:
- 1
- Justification:
- Appropriate completeness and adequacy of the database
- AF for remaining uncertainties:
- 1
- Justification:
- Not applicable
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.635 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):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 65.4 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Dermal NOAEL = oral NOAEL * (ABS oral / ABS dermal) with Oral NOAEL = 6.54 mg/kg bw/d; ABS oral = 100%; ABS dermal = 10% (Supported by experimental data from other THP+salts and known reactivity of THPC-urea for amine moeity, see guidance R.7). Dermal NOAEL = 65.4 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as the starting point
- AF for differences in duration of exposure:
- 2
- Justification:
- Sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Standard factor for interspecies differences Rat vs Human
- AF for other interspecies differences:
- 1
- Justification:
- Hepatotoxicity was observed in three species (rat, mouse and dog) treated with THPX substances in sub-acute, sub-chronic and chronic studies by oral route. Therefore, This AF is considered = 1. (See Table 1)
- AF for intraspecies differences:
- 5
- Justification:
- Default factor used for worker
- AF for the quality of the whole database:
- 1
- Justification:
- Appropriate completeness and adequacy of the database
- AF for remaining uncertainties:
- 1
- Justification:
- Not applicable
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
Hepatotoxicity was observed in three species (rat, mouse and dog) treated with THPX substances in sub-acute, sub-chronic and chronic studies by oral route. Therefore, The AF for other interspecies differences is considered = 1 instead of 2.5. (See Table 1).
Table 1:Database on repeated-dose NOAEL/LOAEL (gavage) on THPX substances characterising the lowest observed effect: hepatotoxicity.Doses mg/kg bw/day expressed as active ingredient content.
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Hepatotoxicity |
THPC-Urea (Cas N° :27104-30-9) |
THPS (CAS N° : 55566-30-8) |
THPC (CAS N° : 124-64-1) |
Perform ST/STI (CAS N° : 359406-89-6) |
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28 days – Oral (mg AI/kg bw/day) |
NOAEL |
Not achieved |
No histopathology |
No study |
5 |
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LOAEL |
52 |
15 |
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90 days - oral – rat (mg AI/kg bw/day) |
NOAEL |
6.54 13.1 |
0.75 |
No study |
2.5 5 |
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LOAEL |
3.75 |
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90 days - oral - rat |
NOAEL |
No study |
5 |
3.75 |
No study |
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LOAEL |
10 |
7.5 |
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90 days - oral - mouse |
NOAEL |
No study |
10 |
4.5 |
No study |
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LOAEL |
20 |
15 |
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90-days - oral – dog (mg AI/kg bw/day) |
NOAEL |
No study |
0.75 |
No study |
No study |
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LOAEL |
4.75 |
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2 years - oral – rat (mg AI/kg bw/day) |
NOAEL |
No study |
Not achieved |
Not achieved |
No study |
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LOAEL |
5 (other doses: 10 mg/kg bw/day) |
3.75 (other dose: 7.5 mg/kg bw/day) |
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2 years - oral – mouse (mg AI/kg bw/day) |
NOAEL |
No study |
Not achieved |
Not achieved |
No study |
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LOAEL |
5 (other doses: 10 mg/kg bw/day) |
7.5 (other dose: 15 mg/kg bw/day) |
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General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard via dermal 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
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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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