Registration Dossier
Registration Dossier
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EC number: 221-453-2 | CAS number: 3101-60-8
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.5 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):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 88.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- NOAECcorr=NOAELoral*(1/0.38 m3/kg/d)*(ABSoral-rat/ABSinhhuman)*(6.7 m3 (8h)/10 m3(8h)) = 100 mg/kg/d*(1/0.38 m3/kg/d)*(0.5*1)*0.67=88.2 mg/m3
- AF for differences in duration of exposure:
- 2
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.5 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):
- 25
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor:
- NOAEC
- Value:
- 100
- AF for differences in duration of exposure:
- 2
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- DNEL extrapolated from long term DNEL
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 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:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
An Allometric Scaling Factor of 4 plus an additional Assessment Factor of 2.5-fold was applies as per E.C.H.A. Guidance on information requirements and chemical safety assessment Chapter R.8:
Characterisation of the dose [concentration]-response for human health, page 30 and Table R.8-3. An Intraspecies Worker Assessment of 5-fold is used as per E.C.H.A. Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of the dose [concentration]-response for human health.Appendix R.8-3, Table R.8-19, page 76 with a Duration correction of subacute to chronic exposure of 2-fold.
- AF for differences in duration of exposure:
- 2
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 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
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.6 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 63
- Dose descriptor:
- other: LOAEL
- Justification:
- EC3 calculated as per REACH guidance Chapter R.8. Appendix R. 8-10, Skin Sensitization, page 128.
- Justification:
- Not applicable
- AF for interspecies differences (allometric scaling):
- 7
- Justification:
- As per REACh guidance Chapter R.8. Table R. 8-3, page 30
- AF for intraspecies differences:
- 3
- Justification:
- As per REACH guidance Chapter R.8. Table R. 8-19, pages 76-77.
- Justification:
- Mouse LLNA was conducted as per OECD guideline with GLP compliance, no AF required.
- AF for remaining uncertainties:
- 3
- Justification:
- LOAEL to NOAEL as per REACH guidance Chapter R.8, Appendix R. 8-10, page 128 and Section R.8.4.3.1. page 36.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.6 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 63
- Dose descriptor starting point:
- other: LOAEL
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
DNELs for long-term inhalation and dermal exposures are judged to be protective for acute short-term effects. The DNEL derived for dermal local long-term sensitisation effects is judged to be protective for dermal local acute/short-term sensitisation effects.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.75 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 88.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- NOAECcorr=NOAELoral*(1/0.38m3/kg/d)*(ABSoral-rat/ABSinhhuman)*(6.7m3(8h)/10m3(8h)) = 100 mg/kg/d*(1/0.38 m3/kg/d)*(0.5*1)*0.67=88.2 mg/m3
- AF for differences in duration of exposure:
- 2
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 3
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.75 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor:
- NOAEC
- Value:
- 88.2 mg/m³
- AF for differences in duration of exposure:
- 2
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 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:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
An Allometric Scaling Factor of 4 plus an additional Assessment Factor of 2.5-fold was applies as per E.C.H.A. Guidance on information requirements and chemical safety assessment Chapter R.8:
Characterisation of the dose [concentration]-response for human health, page 30 and Table R.8-3. An Intraspecies General Population Assessment of 10-fold is used as per E.C.H.A. Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of the dose [concentration]-response for human health.Appendix R.8-3, Table R.8-19, page 76 with a Duration correction of subacute to chronic exposure of 2-fold.
- AF for differences in duration of exposure:
- 2
- AF for interspecies differences (allometric scaling):
- 4
- AF for intraspecies differences:
- 2.5
- AF for the quality of the whole database:
- 10
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 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
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.95 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 105
- Dose descriptor:
- other: EC3
- AF for dose response relationship:
- 3
- Justification:
- LOAEL to NOAEL as per ECHA guidance Chapter R.8. Appendix R.8-10, Skin Sensitisation and Section R.8.4.3.1. page 36.
- Justification:
- Not applicable
- AF for interspecies differences (allometric scaling):
- 7
- Justification:
- ECHA guidance Chapter R.8 Table 8-3, page 30.
- AF for intraspecies differences:
- 5
- Justification:
- ECHA guidance Chapter R.8. Table R.8-19, pages 76-77
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.95 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 105
- Dose descriptor starting point:
- other: LOAEL
General Population - Hazard via oral route
Systemic 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 for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
An inhalation DNEL for both short and long term expsoure of 1.75 mg/m3 is established. The systemic effects dermal DNEL is 0.5 mg/kg/day. A dermal local effects DNEL of 0.95 ug/cm2 is establishe to protect the General Population from skin sensitization.
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.
