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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: 413-110-2 | CAS number: 135861-56-2
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 14.3 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 358.3 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No experimental data available for the inhalation route.
- AF for dose response relationship:
- 1
- Justification:
- Experimental data show reliable dose-response relationship
- AF for differences in duration of exposure:
- 2
- Justification:
- Sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Rat to human correction undertaken during route-to route extrapolation of starting dose
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard default value in ECHA guidance.
- AF for intraspecies differences:
- 5
- Justification:
- Standard default value in ECHA guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- Data base is good
- AF for remaining uncertainties:
- 1
- Justification:
- No other uncertainties apparent
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.1 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 406.4 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No experimental data available for the repeated dose dermal route.
- AF for dose response relationship:
- 1
- Justification:
- Experimental data show reliable dose-response relationship.
- AF for differences in duration of exposure:
- 2
- Justification:
- Sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard default value in ECHA guidance.
- AF for intraspecies differences:
- 5
- Justification:
- Standard default value in ECHA guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- Data base is good
- AF for remaining uncertainties:
- 1
- Justification:
- No other uncertainties apparent
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
The DNEL for long-term inhalation exposure was derived from a NOAEL of 406.4 mg/kg bw/day for a sub-chronic dietary toxicity study in rats (Pharmakon Europe, 1993) . The corrected starting dose was calculated using the formula 406.4 mg/kg bw/day x 1/0.38 (rat standard breathing volume) x 0.5 (absorption differences) x 6.7/10 0 (light worker activity) = 358.3. mg/m3. An overall assessment factor of 25 was calculated, based on the ECHA guidance in R8, Figure R-6, May 2008, giving a DNEL of 14.3 mg/m3.
The DNEL for long-term dermal exposure was derived from a NOAEL of 406.4 mg/kg bw/day for a sub-chronic oral toxicity study in rats (Pharmakon Europe, 1993). The corrected starting dose was calculated using the formula 406.4 mg/kg bw/day x 1 (absorption difference) = 406.5 mg/kg bw/day. An allometric scaling factor of 4 was used (rat to human) and an overall assessment factor of 100 was calculated, based on the ECHA guidance in R8, Figure R-6, May 2008, giving a DNEL of 4.1 mg/kg bw/day.
General Population - 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):
- 50
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 176.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No experimental data available for the inhalation route.
- AF for dose response relationship:
- 1
- Justification:
- Experimental data show reliable dose-response relationship
- AF for differences in duration of exposure:
- 2
- Justification:
- Sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Rat to human correction undertaken during route-to route extrapolation of starting dose
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard default value in ECHA guidance.
- AF for intraspecies differences:
- 10
- Justification:
- Standard default value in ECHA guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- Data base is good
- AF for remaining uncertainties:
- 1
- Justification:
- No other uncertainties apparent
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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:
- 2 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 406.4 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No experimental data available for the dermal route.
- AF for dose response relationship:
- 1
- Justification:
- Experimental data show reliable dose-response relationship
- AF for differences in duration of exposure:
- 2
- Justification:
- Sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard default value in ECHA guidance.
- AF for intraspecies differences:
- 10
- Justification:
- Standard default value in ECHA guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- Data base is good
- AF for remaining uncertainties:
- 1
- Justification:
- No other uncertainties apparent
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 406.4 ng/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Experimental data show reliable dose-response relationship
- AF for differences in duration of exposure:
- 2
- Justification:
- Sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard default value in ECHA guidance.
- AF for intraspecies differences:
- 10
- Justification:
- Standard default value in ECHA guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- Data base is good
- AF for remaining uncertainties:
- 1
- Justification:
- No other uncertainties apparent
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
The DNEL for long-term inhalation exposure was derived from a NOAEL of 406.5 mg/kg bw/day from a sub-chronic dietary toxicity study in rats (Pharmakon Europe, 1993). The corrected starting dose was calculated using the formula 406.4 mg/kg bw/day x 1/1.15 (rat standard breathing volume) x 0.5 (absorption differences) = 176.7 mg/m3. An overall assessment factor of 50 was calculated, based on the ECHA guidance given in R8, Figure R-6, May 2008, giving a DNEL of 3.5 mg/m3.
The DNEL for long-term dermal exposure was derived from a NOAEL of 406.5 mg/kg bw/day from a sub-chronic oral toxicity study in rats (Pharmakon Europe, 1993). The corrected starting dose was calculated using the formula 406.4 mg/kg bw/day x 1 (absorption difference) = 406.5 mg/kg bw/day. An allometric scaling factor of 4 was used (rat to human) and an overall assessment factor of 200 was calculated, based on the ECHA guidance given in R8, Figure R-6, May 2008, giving a DNEL of 2.0 mg/kg bw/day.
The DNEL for long-term oral exposure was derived from a NOAEL of 406.4 mg/kg bw/day from a sub-chronic dietary toxicity study in rats (Pharmakon Europe, 1993). Using an allometirc scaling factor of 4 (rat to human) and overall assessment factor of 200 was calculated, based on the ECHA guidance given in R8, Figure R-6, May 2008, giving a DNEL of 2.0 mg/kg bw/day.
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