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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
DMEL (Derived Minimum Effect Level)
Value:
45 µg/m³
Most sensitive endpoint:
carcinogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
3 125
Modified dose descriptor starting point:
T25
Value:
141 mg/m³
Explanation for the modification of the dose descriptor starting point:
T25 of 57 mg/kg/d (rat, oral) corrected to T25 (workers, inhalation) according to ECHA Guidance R8 Appendix R8-6 and R8-7
AF for dose response relationship:
2.5
Justification:
T25 used
AF for differences in duration of exposure:
1
Justification:
103 weeks rat study
AF for interspecies differences (allometric scaling):
2.5
Justification:
ECHA Guidance
AF for other interspecies differences:
1
Justification:
ECHA Guidance
AF for intraspecies differences:
5
Justification:
workers
AF for the quality of the whole database:
10
Justification:
point of comparison
AF for remaining uncertainties:
10
Justification:
nature of carcinogenic process
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.24 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
AF for differences in duration of exposure:
2
Justification:
13 wk study
AF for interspecies differences (allometric scaling):
1
Justification:
inhalation study in rat
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance
AF for intraspecies differences:
5
Justification:
workers
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.72 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
8.33
Dose descriptor starting point:
NOAEC

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
12.76 µg/kg bw/day
Most sensitive endpoint:
carcinogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12 500
Modified dose descriptor starting point:
T25
Value:
159.6 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
See ECHA Guidance R8 page 21 (oral = dermal)
AF for dose response relationship:
2.5
Justification:
T25 used
AF for differences in duration of exposure:
1
Justification:
103 weeks oral study
AF for interspecies differences (allometric scaling):
10
Justification:
ECHA Guidance
AF for other interspecies differences:
1
Justification:
ECHA Guidance
AF for intraspecies differences:
5
Justification:
workers
AF for the quality of the whole database:
10
Justification:
point of comparison
AF for remaining uncertainties:
10
Justification:
nature of carcinogenic process
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.24 µg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor:
other: NOAEL
AF for differences in duration of exposure:
5
Justification:
45d study in rat (oral)
AF for interspecies differences (allometric scaling):
1
Justification:
local effects
AF for other interspecies differences:
1
Justification:
ECHA Guidance
AF for intraspecies differences:
5
Justification:
workers
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.72 µg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
8.33
Dose descriptor starting point:
other: NOAEL

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
4 µg/m³
Most sensitive endpoint:
carcinogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
6 250
Modified dose descriptor starting point:
T25
Value:
24.8 mg/m³
Explanation for the modification of the dose descriptor starting point:
T25 of 57 mg/kg/d (rat, oral) corrected to T25 for consumers at 24hr/day via multiplication with 1/1.15 and 1/2 (ECHA Guidance)
AF for dose response relationship:
2.5
Justification:
T25 used
AF for differences in duration of exposure:
1
Justification:
103 wk rat study
AF for interspecies differences (allometric scaling):
2.5
Justification:
ECHA Guidance
AF for other interspecies differences:
1
Justification:
ECHA Guidance
AF for intraspecies differences:
10
Justification:
consumers
AF for the quality of the whole database:
10
Justification:
point of comparison
AF for remaining uncertainties:
10
Justification:
nature of carcinogenic process
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.06 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
AF for differences in duration of exposure:
2
Justification:
13wk study
AF for interspecies differences (allometric scaling):
1
Justification:
inhalation study
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance
AF for intraspecies differences:
10
Justification:
consumers
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.18 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
16.67
Dose descriptor starting point:
NOAEC

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
2.3 µg/kg bw/day
Most sensitive endpoint:
carcinogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25 000
Modified dose descriptor starting point:
T25
Value:
57 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
See Guidance R8 page 21 (oral = dermal)
AF for dose response relationship:
2.5
Justification:
T25 used
AF for differences in duration of exposure:
1
Justification:
103 week study
AF for interspecies differences (allometric scaling):
10
Justification:
ECHA Guidance
AF for other interspecies differences:
1
Justification:
ECHA Guidance
AF for intraspecies differences:
10
Justification:
consumers
AF for the quality of the whole database:
10
Justification:
point of comparison
AF for remaining uncertainties:
10
Justification:
nature of carcinogenic process
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.12 µg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor:
other: NOAEL
AF for differences in duration of exposure:
5
Justification:
45d study (rat, oral)
AF for interspecies differences (allometric scaling):
1
Justification:
local effects
AF for other interspecies differences:
1
AF for intraspecies differences:
10
Justification:
consumers
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.36 µg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
16.67
Dose descriptor starting point:
other: NOAEL

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
2.3 µg/kg bw/day
Most sensitive endpoint:
carcinogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25 000
Modified dose descriptor starting point:
T25
Value:
57 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
See ECHA Guidance R8 Appendix R8-6 and R8-7
AF for dose response relationship:
2.5
Justification:
T25 used
AF for differences in duration of exposure:
1
Justification:
103 weeks oral rat study
AF for interspecies differences (allometric scaling):
10
Justification:
ECHA Guidance
AF for other interspecies differences:
1
Justification:
ECHA Guidance
AF for intraspecies differences:
10
Justification:
consumers
AF for the quality of the whole database:
10
Justification:
point of comparison
AF for remaining uncertainties:
10
Justification:
nature of carcinogenic process
Acute/short term exposure
Hazard assessment conclusion:
high 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:
high hazard (no threshold derived)

Additional information - General Population