Registration Dossier
Registration Dossier
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EC number: 436-230-7 | CAS number: 359406-89-6
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.44 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:
- 4.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Corrected inhalatory NOAEC = Oral NOAELx(Abs oral rat/Abs inh human) x (1/sRVrat8h) x (sRVhuman8h/wRVhuman8h) = 2.5 mg/kg x (1/0.38) x (6.7/10) = 4.4 mg/m3; ABS oral rat = 100% (Hepatotoxicity effects indicate total absorption of the substance), ABS inh human = 100%= 100%
- 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 scalling used in derivation of inhalation DNEL
- AF for other interspecies differences:
- 1
- Justification:
- Standard factor used for interspecies remaining differences is 2.5. However, 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 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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.63 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:
- 25 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Dermal NOAEL = oral NOAEL x (ABS oral/ABS dermal) with oral NOAEL = 2.5 mg AI/kg bw/day; ABS oral = 100%; ABS dermal = 10% (based on physicochemical properties & worst case THPS absorption 4.80%). Dermal NOAEL = 25 mg AI/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:
- Standard factor used for interspecies remaining differences is 2.5. However, 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.
- 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:
- high hazard (no threshold derived)
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
Standard factor used for interspecies remaining differences is 2.5. However, 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 below).
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.
Hepatotoxycity |
THPC-Urea |
THPS |
THPC |
Perform ST/ STi |
|
CAS#27104-30-9 |
CAS#55566-30-8 |
CAS#124-64-1 |
CAS#359406-89-1 |
||
28 days – Oral (mg AI/kg bw/day) |
NOAEL |
Not achieved |
No histopathology |
No study |
5 |
LOAEL |
52 |
15 |
|||
|
|||||
90 days – Oral – rats (mg AI/kg bw/day) |
NOAEL |
6.54 |
0.75 |
No study |
2.5 |
LOAEL |
13.1 |
3.75 |
5 |
||
90 days – Oral – rats NTP (mg AI/kg bw/day) |
NOAEL |
No study |
5 |
3.75 |
No study |
LOAEL |
10 |
7.5 |
|||
90 days – Oral – mouse NTP (mg AI/kg bw/day) |
NOAEL |
No study |
10 |
4.5 |
No study |
LOAEL |
20 |
15 |
|||
90 days – Oral – dog mg AI/kg bw/day |
NOAEL |
No study |
0.75 |
No study |
No study |
LOAEL |
4.75 |
||||
|
|||||
2 years – Oral – rat (mg AI/kg bw/day) |
NOAEL |
No study |
Not achieved |
Not achieved 3.75 (other dose: 7.5 mg/kg bw day) |
No study |
LOAEL |
5 (other dose: 10 mg/kg bw day) |
||||
2 years – Oral – mouse (mg AI/kg bw/day) |
NOAEL |
No study |
Not achieved |
Not achieved 7.5 (other dose: 15 mg/kg bw day) |
No study |
LOAEL |
5 (other dose: 10 mg/kg bw day) |
||||
General Population - Hazard via inhalation 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
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
Exposure of general population is not foreseen. The life cycle of THPC-urea-amine is short and restricted to industrial uses. It covers three steps:
1-Manufacturing in chemical production plant with high level of safety
2-Formulation on industrial sites licensed to use THPC-urea-amine only in accordance with a user manual setting the safety requirements.
3- Fabric treatment to impart flame retardant properties on the same licensed industrial sites.
Specific steps in the technical process lead to the complete reaction and/or destruction of the remaining THPC-urea-amine during the treatment of the fabric and the aqueous liquors. The THPC-urea-amine monomer is polymerised within the treated fabrics and therefore is not present in the textiles. In addition, following chemical or UV degradation the polymer in the treated fabric does not breakdown to release THPC-urea-amine monomer.
Therefore, no DNELs for general population are defined.
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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