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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.06 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:
0.8 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
1.4 mg/m³
Explanation for the modification of the dose descriptor starting point:

The DNEL for systemic effects via the inhalation route is derived on the NOAEL from the oral 90-day study in which the NOAEL was 0.8 mg/kg bw/day. Correction for respiratory rate and volume (rat to human worker): (6.7 m3/d/10 m3/d)*(1/0.38 m3/kg) (default). Therefore, the corrected NOAEC for repeated-dose systemic effects via the inhalation route is [0.8 mg/kg bw/day*(6.7 m3/d/10 m3/d)*(1/0.38 m3/kg)] = 1.4 mg/m3

AF for dose response relationship:
1
Justification:
The starting point is the oral NOAEL which was the low dose tested. There was a dose response in incidence and severity of effects.
AF for differences in duration of exposure:
2
Justification:
default (sub-chronic to chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
not required for inhalation route
AF for other interspecies differences:
2.5
Justification:
default
AF for intraspecies differences:
5
Justification:
default
AF for the quality of the whole database:
1
Justification:
available studies are good quality
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
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:
0.008 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:
0.8 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
0.8 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The DNEL for systemic effects via the dermal route is derived on the NOAEL from the oral 90-day study in which the NOAEL was 0.8 mg/kg bw/day. No corrections were made to the NOAEL. Therefore, the NOAEL for repeated-dose systemic effects via the dermal route is = 0.8 mg/kg bw/day. Although dermal absorption of the parent substance was demonstrated to be <0.1% in vitro signs of systemic toxicity were recorded in acute and repeat dose toxicity studies conducted by the dermal route indicating systemic exposure of substance-related material had occurred. Therefore, no correction for dermal absorption is applied.

AF for dose response relationship:
1
Justification:
The starting point is the oral NOAEL which was the lowest dose tested. There was a dose response in incidence and severity of effects.
AF for differences in duration of exposure:
2
Justification:
default (sub-chronic to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
default (rat to human)
AF for other interspecies differences:
2.5
Justification:
default
AF for intraspecies differences:
5
Justification:
default
AF for the quality of the whole database:
1
Justification:
available studies are good quality
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Short-term high exposures are considered unlikely given the high levels of control in place at sites producing and using the substance. DNELs for long-term exposure are therefore adequate to protect against short-term exposures and no separate short-term DNELs are calculated.

General Population - Hazard via inhalation 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

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:
no hazard identified
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:
0.004 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:
0.8 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
0.8 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The DNEL for systemic effects via the dermal route is derived on the NOAEL from the oral 90-day study in which the NOAEL was 0.8 mg/kg bw/day. No corrections were made to the NOAEL. Therefore, the NOAEL for repeated-dose systemic effects via the dermal route is = 0.8 mg/kg bw/day.

AF for dose response relationship:
1
Justification:
The starting point is the oral NOAEL which was the low dose tested. There was a dose response in incidence and severity of effects.
AF for differences in duration of exposure:
2
Justification:
default (sub-chronic to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
default (rat to human)
AF for other interspecies differences:
2.5
Justification:
default
AF for intraspecies differences:
10
Justification:
default
AF for the quality of the whole database:
1
Justification:
available studies are good quality
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population