Registration Dossier
Registration Dossier
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EC number: 947-985-1 | 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:
- 6.975 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):
- 30
- Dose descriptor starting point:
- NOAEL
- Value:
- 237 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 208.93 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The NOAEL of 500 mg/kg bw/day established in the combined 28-day repeated dose toxicity study/reproductive toxicity screening study (oral route, OECD 422; Griffiths, 2018) translates into a dose of 237 mg/kg bw/day of THEMAH (purity 47.3%) and was used to derive a DNEL long-term, systemic effects via the inhalation route. After route-to-route extrapolation from oral to inhalation, the dose descriptor starting point NOAEC is 208.93 mg/m³ = 237 mg/kg bw/day x 1/0.38 m³/kg/day x 0.67 x 0.5. 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 respective conditions (6.7 m³ for base level, 10 m³ for light activity).
A correction factor of 0.5 is applied as bioavailability after oral exposure is assumed to be 50% and the bioavailability after inhalation exposure is assumed to be 100%.
- 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:
- 6
- Justification:
- difference in study duration, subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- included in the route-to-route extrapolation
- AF for other interspecies differences:
- 1
- Justification:
- default assessment factor, local effects
- 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:
- 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:
- 1.975 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):
- 120
- Dose descriptor starting point:
- NOAEL
- Value:
- 237 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 237 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 combined repeated dose toxicity study with reproduction/developmental toxicity screening study (OECD 422; Griffiths, 2018) could be used after extrapolation to the dermal route. The NOAEL was established at 500 mg/kg bw/d, which translates in a dose of 237 mg/kg bw/d (purity 47.3%). For route-to-route extrapolation from oral to dermal, no default factor (i.e. factor 1) should be applied as part of the overall assessment factor, as it is assumed that dermal absorption will not be higher than oral absorption (50%).
- AF for dose response relationship:
- 1
- Justification:
- NOAEL was used as starting point; no additional assessment factor required
- AF for differences in duration of exposure:
- 6
- Justification:
- difference in study duration subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 1
- Justification:
- default assessment factor, local effects
- 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:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- medium 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
No consumer use is expected, therefore no hazard assessment for the general population is performed.
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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