Registration Dossier
Registration Dossier
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EC number: 406-080-7 | CAS number: 83016-70-0 JEFFCAT ZF-10; TEXACAT ZF-10
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.53 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:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 88.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
As no long-term study via inhalation is available, route-to-route extrapolation has been performed. The NOAEL observed in the 90 -day repeated dose toxicity study (Huntsman, 2013) was used to derive a DNEL long-term, systemic effects via the inhalation route. For the route-to-route extrapolation from oral to inhalation, the dose descriptor starting point = 100 mg/kg bw/d x 1/(0.38 m3/kg/d) x 6.7m3/10 m3 x 0.5 = 88.16 mg/m3. The oral dose for rats was converted to the corresponding air concentration using a standard breathing volume for the rat (0.38 m3/kg for 8 hours exposure for workers). For workers, the resulting air concentration needs to be additionally corrected for the difference between basal caloric demand and caloric demand under light activity. This correction factor is derived from the inhaled volumes in 8 hours under the respective conditions (6.7 m3 for base level, 10 m3 for light activity). In addition, the NOAEL needs to be divided by 2 as the bioavailability via the inhalation route is considered as 100% while for oral exposure this is only 50%.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as starting point, no additional assessment factor required
- AF for differences in duration of exposure:
- 2
- Justification:
- difference in study duration, subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- covered by calculation for route-to-route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- default assessment factor
- AF for intraspecies differences:
- 5
- Justification:
- worker population
- AF for the quality of the whole database:
- 1
- Justification:
- default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- default assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 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:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No long-term dermal toxicity study is available for the test substance. However, data from an oral 90 -day repeated dose toxicity study (Huntsman, 2013) could be used after extrapolation to the dermal route. The NOAEL was established at 100 mg/kg bw/day. For route-to-route extrapolation (oral to dermal), no additional correction factor should be applied as it is assumed that dermal absorption will not be higher compared to oral absorption.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL as starting point
- AF for differences in duration of exposure:
- 2
- Justification:
- difference in duration, subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- default assessment factor
- AF for intraspecies differences:
- 5
- Justification:
- worker population
- AF for the quality of the whole database:
- 1
- Justification:
- default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- default assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
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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