Registration Dossier
Registration Dossier
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EC number: 939-455-3 | CAS number: 1469983-49-0
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:
- 21.2 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:
- 600 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 529 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Standard oral to inhalation route-to-route extrapolation (According to ECHA Guidance R8):
Corrected inhalatory NOAEC = oral NOAEL x 1/standard Respiratory Volume (rat)* Absorption oral-rat/Absorption inh-human * standard Repiratory Volume (Human)/worker Respiratory Volume
Corrected inhalatory NOAEL = 600 x 1/0.38 m3/kg/day * 50/100 * 6.7 m3 (8h)/10 m3 (8h)= 529 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- Oral NOAEL used as a starting point
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic (OECD 408 study) to chronic duration extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling used in derivation of inhalation DNEL
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard factor for remaining interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- Standard factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Appropriate completeness and adequacy of the database
- AF for remaining uncertainties:
- 1
- Justification:
- Not applicable
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6 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:
- 600 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Standard oral to dermal route-to-route extrapolation: no modification of the "starting point" is applied as the oral and dermal absorptions are considered equivalent.
- AF for dose response relationship:
- 1
- Justification:
- Oral NOAEL used as a starting point
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic (OECD 408 study) to chronic duration extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Standard factor for the rat species
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard factor for remaining interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- Standard factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Appropriate completeness and adequacy of the database
- AF for remaining uncertainties:
- 1
- Justification:
- Not applicable
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.2 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 261 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Standard oral to inhalation route-to-route extrapolation for consumers (according to ECHA Guidance R8):
Corrected inhalatory NOAEC = oral NOAEL * 1/standard Respiratory Volume (rat) * Absorption oral-rat/Absorption inh-humman
Corrected inhalatory NOAEC = 600 * 1/1.15 m3/kg/d * 50/100
- AF for dose response relationship:
- 1
- Justification:
- Oral NOAEL used as a starting point
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic (OECD 408 study) to chronic duration extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling used in derivation of inhalation DNEL
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard factor for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- Standard factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Appropriate completeness and adequacy of the database
- AF for remaining uncertainties:
- 1
- Justification:
- Not applicable
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Standard oral to dermal route-to-route extrapolation: no modification of the "starting point" as oral and dermal absorptions are considered equivalent.
- AF for dose response relationship:
- 1
- Justification:
- Oral NOAEL used as a starting dose
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic (OECD 408) to chronic duration extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Standard factor for the rat species
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard factor for remaining interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- Standard factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Appropriate completeness and adequacy of the database
- AF for remaining uncertainties:
- 1
- Justification:
- Not applicable
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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:
- 3 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No correction is applied to the "starting point" as the oral absorption considered equivalent in rats and humans in the absence of specific absorption data
- AF for dose response relationship:
- 1
- Justification:
- Oral NOAEL used as a starting dose
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic (OECD 408) to chronic duration extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Standard factor for the rat species
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard factor for remaining interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- Standard factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Appropriate completeness and adequacy of the database
- AF for remaining uncertainties:
- 1
- Justification:
- Not applicable
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
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.
