Registration Dossier
Registration Dossier
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EC number: 201-128-1 | CAS number: 78-63-7
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 11 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 264 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Corrected inhalation NOAEC from oral NOAEL of 150 mg/kg/day. Assume ABSoral-rat/ABSinh-human is equal (1) =150 mg/kg bw/day x (1/0.38m3/kg bw/day) x (1.0) x (6.7m3/10m3) = 264 mg/m3 inhalation dose descriptor.
- AF for dose response relationship:
- 1
- Justification:
- Based on REACH guidance
- AF for differences in duration of exposure:
- 2
- Justification:
- Based on REACH guidance
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Based on REACH guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- Based on REACH guidance
- AF for intraspecies differences:
- 5
- Justification:
- Based on REACH guidance
- AF for the quality of the whole database:
- 1
- Justification:
- Based on REACH guidance
- AF for remaining uncertainties:
- 1
- Justification:
- Based on REACH guidance
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:
- 15 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
A systemic NOAEL of 150 mg/kg/day is based on the 90-day oral rat gavage study (OECD 408). Oral absorption rat — oral/dermal absorption human: Assume 10% dermal absorption. Therefore, 150 mg/kg bw/day/0.1 = 1500 mg/kg bw/day dermal dose descriptor.
- AF for dose response relationship:
- 1
- Justification:
- REACH guidance
- AF for differences in duration of exposure:
- 2
- Justification:
- REACH guidance
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- REACH guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- REACH guidance
- AF for intraspecies differences:
- 5
- Justification:
- REACH guidance
- AF for the quality of the whole database:
- 1
- Justification:
- REACH guidance
- AF for remaining uncertainties:
- 1
- Justification:
- REACH guidance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
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:
- no hazard identified
Additional information - workers
Systemic Dermal DNEL Worker
A systemic NOAEL of 150 mg/kg/day is based on the 90-day oral rat gavage study (OECD 408).
Oral absorption rat — oral/dermal absorption human: Assume 10% dermal absorption based on molecular weight of 290.4, a log Pow of 7.34, water solubility of 131 μg/l and calculated vapor pressure of 0.00951 mm Hg (1.268 Pa) at 25 °C. Dermal absorption is unlikely due to the low water solubility and high partition coefficient.
= 150 mg/kg bw/day/0.1
= 1500 mg/kg bw/day dermal dose descriptor
Correction for interspecies differences (apply factor for allometric scaling 4 for rat x 2.5 for additional factors):10
= 1500 mg/kg bw/day/10
= 150 mg/kg bw/day
Correction for intraspecies differences: 5
= 150 mg/kg bw/day/5
= 30 mg/kg bw/day
Correction for duration between 90-day sub-chronic to chronic: 2
= 30 mg/kg bw/day/2
= 15 mg/kg bw/day
Correction for dose-response: 1
= 15 mg/kg bw/day/1
= 15 mg/kg bw/day
Correction of whole database: 1 due to quality of study
= 15 mg/kg bw/day/1
= 15 mg/kg bw/day (DNEL dermal-worker-systemic)
based on an overall AF of 100
Systemic Inhalation DNEL Workers
A systemic NOAEL of 150 mg/kg/day is based on the 90-day oral rat gavage study (OECD 408).
Corrected inhalation NOAEC from oral NOAEL
oral NOAEL x (1/sRVrat)x(ABSoral-rat/ABSinh-human)x(sRVhuman/wRV)
Assume ABSoral-rat/ABSinh-human is equal (1)
=150 mg/kg bw/day x (1/0.38m3/kg bw/day) x (1.0) x (6.7m3/10m3)
= 264 mg/m3inhalation dose descriptor
[: Absorption; sRV: standard Respiratory Volume; wRV: worker Respiratory Volume]
Correction for interspecies differences: 2.5
= 264 mg/m3/ 2.5
= 106 mg/m3
Correction for intraspecies differences: 5
= 106 mg/m3/ 5
= 21 mg/m3
Correction for duration between sub-chronic to chronic: 2
= 21 rng/m3/2
= 11 mg/m3
Correction for dose-response: 1
= 11 mg/m3/1
=11 mg/m3
Correction of whole database: 1 due to quality of study
= 11 mg/m3/1
= 11 mg/m3(DNELinhalation-worker-systemic)
based on an overall AF of 25.
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
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