Registration Dossier
Registration Dossier
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EC number: 695-097-5 | CAS number: 15789-90-9
Toxicological information
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 11.75 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):
- 37.5
- Dose descriptor starting point:
- LOAEL
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 440.79 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for differences in duration of exposure:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for intraspecies differences:
- 5
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for the quality of the whole database:
- 3
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for remaining uncertainties:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 352.63 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Dose descriptor starting point:
- other: LD50 cut-off value
- Value:
- 5 000 mg/kg bw/day
- Modified dose descriptor starting point:
- other: LD50
- Value:
- 4 407.89 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for intraspecies differences:
- 5
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for the quality of the whole database:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for remaining uncertainties:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 29.39 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 15
- Dose descriptor:
- LOAEC
- Value:
- 440.79 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for differences in duration of exposure:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for other interspecies differences:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for intraspecies differences:
- 5
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for the quality of the whole database:
- 3
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for remaining uncertainties:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 881.58 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Dose descriptor starting point:
- other: LD50 cut-off value
- Value:
- 4 407.89 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for other interspecies differences:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for intraspecies differences:
- 5
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for the quality of the whole database:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for remaining uncertainties:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.33 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):
- 150
- Dose descriptor starting point:
- LOAEL
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 500 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for differences in duration of exposure:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for intraspecies differences:
- 5
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for the quality of the whole database:
- 3
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for remaining uncertainties:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 100 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- other: LD50 cut-off
- Value:
- 5 000 mg/kg bw/day
- Modified dose descriptor starting point:
- other: LD50 cut-off
- Value:
- 5 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for intraspecies differences:
- 5
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for the quality of the whole database:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for remaining uncertainties:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.33 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 60
- Dose descriptor:
- LOAEC
- Value:
- 500 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for differences in duration of exposure:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for other interspecies differences:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for intraspecies differences:
- 5
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for the quality of the whole database:
- 3
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for remaining uncertainties:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 250 mg/cm²
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 20
- Dose descriptor starting point:
- other: LD50 cut-off
- Value:
- 5 000 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for other interspecies differences:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for intraspecies differences:
- 5
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for the quality of the whole database:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for remaining uncertainties:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
Classified as irritating to eye according to the criteria of directive 67/548/EEC and category 2B according to CLP regulation (EC) n°1272/2008.
All effects were slight to moderate and was fully reversible within a few days.
Concentration for general (consumer) population, the concentration will be below 1%, therefore no hazard is associated for general use levels based on the in vivo eye irritation data.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.9 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):
- 75
- Dose descriptor starting point:
- LOAEC
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 217.39 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for differences in duration of exposure:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for intraspecies differences:
- 10
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for the quality of the whole database:
- 3
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for remaining uncertainties:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 86.96 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- other: LD50 cut-off
- Value:
- 5 000 mg/kg bw/day
- Modified dose descriptor starting point:
- other: LD50 cut-off
- Value:
- 2 173.91 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for intraspecies differences:
- 10
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for the quality of the whole database:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for remaining uncertainties:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7.25 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 30
- Dose descriptor:
- LOAEC
- Value:
- 217.39 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for differences in duration of exposure:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for other interspecies differences:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for intraspecies differences:
- 10
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for the quality of the whole database:
- 3
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for remaining uncertainties:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 217.39 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- DNEL extrapolated from long term DNEL
- Dose descriptor starting point:
- other: LD50 cut-off
- Value:
- 2 173.91 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for other interspecies differences:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for intraspecies differences:
- 10
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for the quality of the whole database:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for remaining uncertainties:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.67 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):
- 300
- Dose descriptor starting point:
- LOAEL
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 500 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for differences in duration of exposure:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for intraspecies differences:
- 10
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for the quality of the whole database:
- 3
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for remaining uncertainties:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 50 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- other: LD50 cut-off
- Value:
- 5 000 mg/kg bw/day
- Modified dose descriptor starting point:
- other: LD50 cut-off
- Value:
- 5 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for intraspecies differences:
- 10
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for the quality of the whole database:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for remaining uncertainties:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.17 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 120
- Dose descriptor:
- LOAEC
- Value:
- 500 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for differences in duration of exposure:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for other interspecies differences:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for intraspecies differences:
- 10
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for the quality of the whole database:
- 3
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for remaining uncertainties:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 125 mg/cm²
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 40
- Dose descriptor starting point:
- other: LD50 cut-off
- Value:
- 5 000 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for other interspecies differences:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for intraspecies differences:
- 10
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for the quality of the whole database:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for remaining uncertainties:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.67 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):
- 300
- Dose descriptor starting point:
- LOAEL
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 500 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for differences in duration of exposure:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for intraspecies differences:
- 10
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for the quality of the whole database:
- 3
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for remaining uncertainties:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 50 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:
- other: LD50 cut-off
- Value:
- 5 000 mg/kg bw/day
- Modified dose descriptor starting point:
- other: LD50 cut-off
- Value:
- 5 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for intraspecies differences:
- 10
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for the quality of the whole database:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
- AF for remaining uncertainties:
- 1
- Justification:
- Standard ECHA REACH Guidance Assessment Factors
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
Classified as irritating to eye according to the criteria of directive 67/548/EEC and category 2B according to CLP regulation (EC) n°1272/2008.
All effects were slight to moderate and was fully reversible within a few days.
Concentration for general (consumer) population, the concentration will be below 1%, therefore no hazard is associated for general use levels based on the in vivo eye irritation data.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
