Registration Dossier
Registration Dossier
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EC number: 601-478-9 | CAS number: 117428-22-5
Toxicological Summary
Administrative data
Workers - 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
Workers - 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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.06 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):
- 70
- Dose descriptor starting point:
- NOAEL
- Value:
- 4.3 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 4.3 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The NOAEL of 4.3 mg/kg/day is the agreed-upon value that was used to derive the ADI as referenced in the EU Commission Review Report (Picoxystrobin, SANCO/10196/2003 – Final 3 June 2003). It is based on the NOAEL from the one-year dog study (CTL/P/6049).
Route–to-route extrapolation: A factor of 1 is appropriate per REACH guidance R.8.4.2 (oral to oral).
- AF for dose response relationship:
- 1
- Justification:
- A factor of 1 is appropriate since the dose descriptor is a NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- This is a default assessment factor for a sub-chronic study per REACH Guidance R.8.4.3.1.
- AF for interspecies differences (allometric scaling):
- 1.4
- Justification:
- A factor of 1.4 is appropriate since the adjusted start point was via mg/kg per REACH guidance R.8.4.3.1.
- AF for other interspecies differences:
- 2.5
- Justification:
- A default factor of 2.5 is appropriate per REACH guidance R.8.4.3.1.
- AF for intraspecies differences:
- 10
- Justification:
- This is a default assessment factor for general population per REACH Guidance R.8.4.3.1.
- AF for the quality of the whole database:
- 1
- Justification:
- A factor of 1 is appropriate because the database is considered to be adequately robust.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
