Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
73.44 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):
18
Modified dose descriptor starting point:
NOAEC
Value:
1 322 mg/m³
Explanation for the modification of the dose descriptor starting point:

The relevant dose descriptor selected to derive the inhalation DNEL, was the subacute oral rat NOAEL of 750 mg/kg bw/day based on no treatment-related effects noted at any of the dose levels. This dose descriptor which is the starting point was corrected for route-to-route extrapolation [i.e., NOAELoral rat ÷ SRvrat x (SRvhuman ÷ WSRvhuman)] in accordance with REACH guidance document R.8 (‘Characterization of dose (concentration)-response for human health’); where: NOAELoral rat = 750 mg/kg bw/d; SRvrat = 0.38 m3/kg bw; SRvhuman = 6.7 m3; WSRvhuman = 10 m3).

AF for dose response relationship:
1
Justification:
Dose-response (starting point is a NOAEL)
AF for differences in duration of exposure:
6
Justification:
Exposure duration (subcaute to chronic)
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:
1
Justification:
Any remaining differences are of intraspecies rather than interspecies variability. Based on this, the additional assessment factor of 2.5 for inter species variability will not be used.
AF for intraspecies differences:
3
Justification:
Intraspecies variation (workers). ECETOC proposed in 2003, based on the scientific evidence, that assessment factors of 3 for workers and 5 for the general population are sufficient for covering any intraspecies variability, which includes the remaining differences factor of 2.5.
AF for the quality of the whole database:
1
Justification:
Good quality
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:
4.16 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12
Modified dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No route to route extrapolation applied

AF for dose response relationship:
1
Justification:
Dose-response (starting point is a NOAEL
AF for differences in duration of exposure:
1
Justification:
Exposure duration (chronic study)
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:
1
Justification:
Any remaining differences are of intraspecies rather than interspecies variability. Based on this, the additional assessment factor of 2.5 for inter species variability will not be used.
AF for intraspecies differences:
3
Justification:
Intraspecies variation (workers). ECETOC proposed in 2003, based on the scientific evidence, that assessment factors of 3 for workers and 5 for the general population are sufficient for covering any intraspecies variability, which includes the remaining differences factor of 2.5.
AF for the quality of the whole database:
1
Justification:
Good quality NTP study
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
93.6 µg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
3
Dose descriptor:
other: corrected LOAEL of 281 µg/cm²
AF for dose response relationship:
1
Justification:
Starting point is NOAEL
AF for differences in duration of exposure:
1
Justification:
Exposure duration (chronic study)
AF for interspecies differences (allometric scaling):
1
Justification:
Assessment factor for interspecies difference - allometric (metabolic rate) scaling (rat-to-human) not required since this is already accounted for when obtaining the corrected LOAEL
AF for other interspecies differences:
1
Justification:
Assessment factor for interspecies difference - remaining non-metabolic differences not required
AF for intraspecies differences:
3
Justification:
Intraspecies variation (workers). ECETOC proposed in 2003, based on the scientific evidence, that assessment factors of 3 for workers and 5 for the general population are sufficient for covering any intraspecies variability, which includes the remaining differences factor of 2.5.
AF for the quality of the whole database:
1
Justification:
Good quality NTP conducted study
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

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:
DNEL (Derived No Effect Level)
Value:
21.73 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):
30
Modified dose descriptor starting point:
NOAEC
Value:
652 mg/m³
Explanation for the modification of the dose descriptor starting point:

The relevant dose descriptor selected to derive the inhalation DNEL, was the subacute oral rat NOAEL of 750 mg/kg bw/day based on no treatment-related effects noted at any of the dose levels. This dose descriptor which is the starting point was corrected for route-to-route extrapolation [i.e., NOAELoral rat ÷ SRvrat] in accordance with REACH guidance document R.8 (‘Characterization of dose (concentration)-response for human health’); where: NOAELoral rat = 750 mg/kg bw/d; SRvrat = 1.15 m3/kg bw.

AF for dose response relationship:
1
Justification:
Dose-response (starting point is a NOEL)
AF for differences in duration of exposure:
6
Justification:
Exposure duration (subacute to chronic)
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:
1
Justification:
Any remaining differences are of intraspecies rather than interspecies variability. Based on this, the additional assessment factor of 2.5 for inter species variability will not be used.
AF for intraspecies differences:
5
Justification:
Intraspecies variation (general population). ECETOC proposed in 2003, based on the scientific evidence, that assessment factors of 3 for workers and 5 for the general population are sufficient for covering any intraspecies variability, which includes the remaining differences factor of 2.5.
AF for the quality of the whole database:
1
Justification:
Good quality
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:
DNEL (Derived No Effect Level)
Value:
2.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
20
Modified dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No route to route extrapolation applied

AF for dose response relationship:
1
Justification:
Dose-response (starting point is a NOAEL)
AF for differences in duration of exposure:
1
Justification:
Exposure duration (chronic study)
AF for interspecies differences (allometric scaling):
4
Justification:
Assessment factor for interspecies difference - allometric (metabolic rate) scaling (rat-to-human)
AF for other interspecies differences:
1
Justification:
Any remaining differences are of intraspecies rather than interspecies variability. Based on this, the additional assessment factor of 2.5 for inter species variability will not be used.
AF for intraspecies differences:
5
Justification:
Intraspecies variation (general population). ECETOC proposed in 2003, based on the scientific evidence, that assessment factors of 3 for workers and 5 for the general population are sufficient for covering any intraspecies variability, which includes the remaining differences factor of 2.5.
AF for the quality of the whole database:
1
Justification:
Good quality
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
56.2 µg/cm²
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Dose descriptor:
other: corrected LOAEL of 281 µg/cm²
AF for dose response relationship:
1
Justification:
Starting point is NOAEL
AF for differences in duration of exposure:
1
Justification:
Exposure duration (chronic study)
AF for interspecies differences (allometric scaling):
1
Justification:
Assessment factor for interspecies difference - allometric (metabolic rate) scaling (rat-to-human) not required
AF for other interspecies differences:
1
Justification:
Assessment factor for interspecies difference - remaining non-metabolic differences not required
AF for intraspecies differences:
5
Justification:
Intraspecies variation (general population). ECETOC proposed in 2003, based on the scientific evidence, that assessment factors of 3 for workers and 5 for the general population are sufficient for covering any intraspecies variability, which includes the remaining differences factor of 2.5.
AF for the quality of the whole database:
1
Justification:
Good quality NTP study
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:
6.25 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):
120
Modified dose descriptor starting point:
NOAEL
Value:
750 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No route to route extrapolation

AF for dose response relationship:
1
Justification:
Dose-response (starting point is a NOAEL)
AF for differences in duration of exposure:
6
Justification:
Exposure duration (sub-acute to chronic study)
AF for interspecies differences (allometric scaling):
4
Justification:
Assessment factor for interspecies difference - allometric (metabolic rate) scaling (rat-to-human)
AF for other interspecies differences:
1
Justification:
Any remaining differences are of intraspecies rather than interspecies variability. Based on this, the additional assessment factor of 2.5 for inter species variability will not be used.
AF for intraspecies differences:
5
Justification:
Intraspecies variation (general population). ECETOC proposed in 2003, based on the scientific evidence, that assessment factors of 3 for workers and 5 for the general population are sufficient for covering any intraspecies variability, which includes the remaining differences factor of 2.5.
AF for the quality of the whole database:
1
Justification:
Good quality study
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population