Registration Dossier
Registration Dossier
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EC number: 695-748-3 | CAS number: 65286-55-7
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.47 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:
- 25 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 61.71 mg/m³
- Explanation for the modification of the dose descriptor starting point:
An NOAEL of 25 mg/kg bw/day was established in the 90-day repeated dose toxicity study (oral route, OECD 408; Chase, 2022).
This dose descriptor starting point was therefore used to derive a DNEL long-term, systemic effects via the inhalation route. After route-to-route extrapolation from oral to inhalation, the modified dose descriptor starting point NOAEC is 61.71 mg/m³ = 25 mg/kg/day x 1/0.38 m³/kg/day x 0.67 x 1 x (7d/5d). 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 7/5 for the difference in exposure duration and frequency was added (7 days/week dosing in the animal study, 5 days/ week exposure of the workers). No additional correction factor is required as the bioavailability after both oral and inhalatory exposure is considered to be 100%.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as starting point
- AF for differences in duration of exposure:
- 2
- Justification:
- Difference in study duration subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Included in the 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:
- 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:
- 0.7 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:
- 25 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 70 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 (OECD 408; Chase, 2022) could be used after extrapolation to the dermal route. The NOAEL established at 25 mg/kg bw/day was therefore used to derive a DNEL long-term, systemic effects via the dermal route.
For route-to-route extrapolation (oral to dermal), a correction factor of 2 should be applied as part of the overall assessment factor, as it is assumed that bioavailability after oral exposure is 100% and after dermal exposure 50%. A correction factor of 7/5 is applied to correct for difference in exposure duration and frequency (7days/ week for the animal study, 5 days/week for the workers) The modified NOAEL was 70mg/kg bw/d ( 25 mg/kg bw/d * 2 * (7d/5d).
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as starting point
- AF for differences in duration of exposure:
- 2
- Justification:
- Difference in study duration subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling from 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:
- No need for further assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- default assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- medium 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:
- 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 effect threshold levels were derived for the general population, as no consumer use is expected.
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