Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 200-064-1 | CAS number: 50-78-2
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:
- 19.5 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):
- 8
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 2.44 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- chronic dose oral
- AF for dose response relationship:
- 1
- Justification:
- oral to inhalation
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 0.7
- Justification:
- 5/7 days
- AF for intraspecies differences:
- 3
- Justification:
- worker
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
- Justification:
- not taken into account: granulometry with only<4 % inhalable, in ordre not to add further exposure to the natural exposure to salicylates trough Food which was estimated to a range from about 10 mg to 200 mg/day salicylate in Western diets (Swain et al., 1985, Research, 85, 950-960)
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:
- 4.9 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):
- 12
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 59.2 mg/kg bw/day
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for intraspecies differences:
- 3
- Justification:
- workers also 5/7 days
- AF for the quality of the whole database:
- 1
- Justification:
- human drug use
- AF for remaining uncertainties:
- 1
- Justification:
- not taken into account low dermal penetration ( < 2%) in ordre not to add further exposure to the natural exposure to salicylates trough Food which was estimated to a range from about 10 mg to 200 mg/day salicylate in Western diets (Swain et al., 1985, Research, 85, 950-960)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Value:
- 1 180 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- 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:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.475 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEC
- AF for dose response relationship:
- 1
- Justification:
- chronic
- AF for differences in duration of exposure:
- 1
- Justification:
- also drug use
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for intraspecies differences:
- 10
- Justification:
- human general population
- AF for the quality of the whole database:
- 1
- Justification:
- human use as drug
- AF for remaining uncertainties:
- 1
- Justification:
- granulometry not taken into account; only few % inhalable
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
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for intraspecies differences:
- 10
- Justification:
- human general population
- AF for the quality of the whole database:
- 1
- Justification:
- human experience
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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- human experience: drug use
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.275 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):
- 40
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEL
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for intraspecies differences:
- 10
- Justification:
- general population
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Population not exposed to dust, only pills.
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.
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