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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.132 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):
37.5
Dose descriptor starting point:
NOAEL
Value:
10 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
4.94 mg/m³
Explanation for the modification of the dose descriptor starting point:

The relevant dose descriptor selected to derive the inhalation DNEL, was the oral rat NOAEL of 10 mg/kg bw/day derived from an 28-d repeated dose toxicity study conducted with the read across substance, C20-22 TMAC. This dose descriptor which is the starting point was corrected for route-to-route extrapolation:

[i.e., NOAEL oral rat ÷ SRvrat x (SRvhuman ÷ WSRvhuman) x (ABSoral-rat/ABSinh-human) x days per week(experimental)/days per week (human population] in accordance with REACH guidance document R.8 (‘Characterization of dose (concentration)-response for human health’) November (2012); where: NOAELoral rat = 10 mg/kg bw/d; SRvrat = 0.38 m3/kg bw; SRvhuman = 6.7 m3; WSRvhuman = 10 m3; ABSoral-rat = 10%; ABSinh-human = 50%; days per week(experimental) = 7 days; days per week (human population) = 5 days for workers) = 10 x 1/0.38 x 6.7/10 x 7/5 x 10/50 = 4.94 mg/m3]

AF for dose response relationship:
1
Justification:
starting point is a NOAEL
AF for differences in duration of exposure:
3
Justification:
Based on PoD the extrapolation should consider an AF of 6 to cover from subacute to chronic exposure. However, longer-term repeated dose studies do not indicate lower NOAELs and thus no dose dependency over time.
AF for interspecies differences (allometric scaling):
1
Justification:
No assessment factor applied for interspecies difference - allometric (metabolic rate) scaling (rat-to-human) since this is already accounted for when obtaining the corrected NOEC
AF for other interspecies differences:
2.5
Justification:
Assessment factors for remaining non-metabolic differences
AF for intraspecies differences:
5
Justification:
Assessment factors for workers
AF for the quality of the whole database:
1
Justification:
Good quality study
AF for remaining uncertainties:
1
Justification:
No additional factors are required
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:
0.187 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):
150
Dose descriptor starting point:
NOAEL
Value:
10 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
28 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The relevant dose descriptor selected to derive the inhalation DNEL, was the oral rat NOAEL of 10 mg/kg bw/day derived from an 28-d repeated dose toxicity study conducted with the read across substance, C20-22 TMAC. This dose descriptor which is the starting point was corrected for route-to-route extrapolation:

[i.e., NOAEL oral rat x (ABSoral-rat/ABSderm-human) x days per week(experimental)/days per week(human population] in accordance with REACH guidance document R.8 (‘Characterization of dose (concentration)-response for human health’) November (2012); where: NOAELoral rat = 10 mg/kg bw/d; ABSoral-rat = 10%; ABSderm-human = 5%; days per week(experimental) = 7 days; days per week(human population) = 5 days for workers) = 10 x 7/5 x 10/5 = 28 mg/kg bw/day]).

AF for dose response relationship:
1
Justification:
starting point is a NOAEL
AF for differences in duration of exposure:
3
Justification:
Based on PoD the extrapolation should consider an AF of 6 to cover from subacute to chronic exposure. However, longer-term repeated dose studies do not indicate lower NOAELs and thus no dose dependency over time.
AF for interspecies differences (allometric scaling):
4
Justification:
Assessment factor applied for interspecies difference - allometric (metabolic rate) scaling (rat-to-human)
AF for other interspecies differences:
2.5
Justification:
Assessment factor for any remaining non-metabolic differences
AF for intraspecies differences:
5
Justification:
Assessment factor for workers
AF for the quality of the whole database:
1
Justification:
Good quality study
AF for remaining uncertainties:
1
Justification:
No additional assessment factors are required
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
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:
medium hazard (no threshold derived)

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

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
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

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
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 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 for general population have been derived as no REACH-relevant consumer use has been identified. The only consumer use is as cosmetic products, which are not within the scope of REACH.