Registration Dossier
Registration Dossier
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EC number: 700-615-0 | 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:
- 2.44 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH GUIDANCE and ECETOC REPORT N°110
- Overall assessment factor (AF):
- 18
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 44 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- NOAEL rat (28 days) = 25 mg/kg/day. It is assumed that inhalation absorption is 50% (MW > 500) and oral absorption is 50% (default factor), then NOAEC = 25*(1/0.38) *(50/50) *(6.7/10) = 44 mg/m³
- AF for differences in duration of exposure:
- 6
- Justification:
- default value for guidance R8.
- AF for interspecies differences (allometric scaling):
- 3
- Justification:
- ECETOC report N°110
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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:
- 1.74 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH GUIDANCE and ECETOC REPORT N° 110
- Overall assessment factor (AF):
- 72
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 125 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- It is assumed that the dermal absorption is 10% (MW > 500) and the oral absorption is 50% (default factor) then strating with NOEL oral (28 days) the corected NOEL dermal (28 days) is 125 mg/kg bw /day
- AF for differences in duration of exposure:
- 6
- Justification:
- Default value for guidance R8
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECETOC report n°110
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC report n°110
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
All the DNEL are based on the NOEL rat (28 days) of 25 mg/kg/day. As no specific organs were affected and as the effect was reversible, the less conservative assessment factor take from ECETOC report N°110 was used.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.72 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH GUIDANCE and ECETOC REPORT N° 110
- Overall assessment factor (AF):
- 30
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 21.73 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- NOAEL rat (28days) = 25 mg/kg/jour. It is assumed that inhalation absorption is 50% and oral absorption is 50% then NOAEC = 25*(1/1.15) *(50%/50%) *(6.7/10) = 21.73 mg/m³
- AF for differences in duration of exposure:
- 6
- Justification:
- Default value for guidance R8
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC report N°110
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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:
- DNEL (Derived No Effect Level)
- Value:
- 1.04 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH GUIDANCE and ECETOC REPORT N° 110
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 125 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- It is assumed that the dermal absorption is 10% and the oral absorption is 50% then staring with NOAEL oral (28 days) the corrected NOEL dermal (28 days) is 125 mg/kg bw /day
- AF for differences in duration of exposure:
- 6
- Justification:
- Default value for guidance R8
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECETOC report N°110
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC report N°110
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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:
- 0.21 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH GUIDANCE and ECETOC REPORT n° 110
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 25 mg/kg bw/day
- AF for differences in duration of exposure:
- 6
- Justification:
- Default value for guidance R8
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECETOC report N°110
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC report N°110
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
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