Registration Dossier
Registration Dossier
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EC number: 221-218-4 | CAS number: 3033-29-2
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.002 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):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 0.4 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 0.35 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Oral NOAELrat× (1/0.38 m3/kg bw) × (6.7 m3/10m3) × (50% /100%) = 0.4 × 2.63 × 0.67 × 0.5
Inhalation NOAEChuman= 0.35 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- The starting point is a clear NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable for inhalation
- AF for other interspecies differences:
- 1
- Justification:
- Addressed by modification of starting point
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers
- AF for the quality of the whole database:
- 2
- Justification:
- Read-across from a structurally related substance
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.006 mg/m³
DNEL related information
- DNEL extrapolated from long term DNEL
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:
- 0.03 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 0.4 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 20 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Oral NOAELrat× (50% / 1%) = 0.4 × 50
Dermal NOAELhuman= 20 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- The starting point is a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human
- AF for other interspecies differences:
- 1
- Justification:
- Addressed by modification of starting point
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers
- AF for the quality of the whole database:
- 2
- Justification:
- Read-across from a structurally related substance
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.09 mg/kg bw/day
DNEL related information
- DNEL extrapolated from long term DNEL
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:
- 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
- Explanation for the modification of the dose descriptor starting point:
No general public exposure is anticipated.
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
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
No general public exposure is anticipated.
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
No general public exposure is anticipated.
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
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
No general public exposure is anticipated.
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
No general public exposure is anticipated.
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
No DNELs have been derived for general population as exposure does not occur during the lifecycle of the substance.
The substance is not used by consumers or professionals and only has manufacture, formulation and industrial uses.
The substance is used in the industrial processing of polymers where it is added as a stabilizer. During the processing of the polymer the substance will be completely used up and as such it does not exist in the final polymer product, therefore in-direct exposure of the general population via releases from the end product is not possible. Indirect exposure of the general population via releases to the environment is also not considered to occur, as the substance is only used in industrial settings where there will be effective waste management processes to prevent release.
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.
