Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.41 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
4 320
Modified dose descriptor starting point:
LOAEC
Value:
1 763 mg/m³
Explanation for the modification of the dose descriptor starting point:
according to ECHA and ECETOC guidelines; there is no evidence that route-to-route extrapolation cannot be applied.
AF for dose response relationship:
8
Justification:
LOAEL based on clinical signs observed in an acute oral toxicity study
AF for differences in duration of exposure:
18
Justification:
assuming chronic exposure of the worker
AF for interspecies differences (allometric scaling):
1
Justification:
no correction for caloric demand for inhalation
AF for other interspecies differences:
1
Justification:
according to ECETOC guideline
AF for intraspecies differences:
3
Justification:
according to ECETOC guideline
AF for the quality of the whole database:
10
Justification:
acute studies available only
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
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:
0.12 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
17 280
Modified dose descriptor starting point:
LOAEL
Value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
not needed, as dermal study is starting point.
AF for dose response relationship:
8
Justification:
LOAEL based on clinical signs observed in an acute dermal toxicity study
AF for differences in duration of exposure:
18
Justification:
assuming chronic exposure of the worker
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
1
Justification:
according to guideline
AF for intraspecies differences:
3
Justification:
according to guideline
AF for the quality of the whole database:
10
Justification:
acute studies available only
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:
DNEL (Derived No Effect Level)
Value:
2.22 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
9
Dose descriptor:
other: LOAEL
AF for dose response relationship:
3
Justification:
extrapolation LOAEL to NOAEL
AF for differences in duration of exposure:
1
Justification:
local effect
AF for interspecies differences (allometric scaling):
1
Justification:
local effect
AF for other interspecies differences:
1
Justification:
according to guideline
AF for intraspecies differences:
3
Justification:
difference in sensitivity among workers
AF for the quality of the whole database:
1
Justification:
no additional assessment factor required
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.22 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
9
Dose descriptor starting point:
other: LOAEL
AF for dose response relationship:
3
Justification:
extrapolation LOAEL to NOAEL
AF for interspecies differences (allometric scaling):
1
Justification:
local effect
AF for other interspecies differences:
1
Justification:
local effect
AF for intraspecies differences:
3
Justification:
difference in sensitivity among workers
AF for the quality of the whole database:
1
Justification:
no additional assessment factor required
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.12 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
7 200
Modified dose descriptor starting point:
LOAEC
Value:
869 mg/m³
Explanation for the modification of the dose descriptor starting point:
according to ECHA and ECETOC guidelines; there is no evidence that route-to-route extrapolation cannot be applied.
AF for dose response relationship:
8
Justification:
LOAEL based on clinical signs observed in an acute oral toxicity study
AF for differences in duration of exposure:
18
Justification:
assuming chronic exposure of the general population
AF for interspecies differences (allometric scaling):
1
Justification:
no correction for caloric demand for inhalation
AF for other interspecies differences:
1
Justification:
according to ECETOC guideline
AF for intraspecies differences:
5
Justification:
according to ECETOC guideline
AF for the quality of the whole database:
10
Justification:
acute studies available only
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.07 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
28 800
Modified dose descriptor starting point:
LOAEL
Value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
not needed, as dermal study is starting point.
AF for dose response relationship:
8
Justification:
LOAEL based on clinical signs observed in an acute dermal toxicity study
AF for differences in duration of exposure:
18
Justification:
assuming chronic exposure of the general population
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
1
Justification:
according to ECETOC guideline
AF for intraspecies differences:
5
Justification:
according to ECETOC guideline
AF for the quality of the whole database:
10
Justification:
acute studies available only
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:
DNEL (Derived No Effect Level)
Value:
1.3 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
15
Dose descriptor:
other: LOAEL
AF for dose response relationship:
3
Justification:
extrapolation from LOAEL to NOAEL
AF for differences in duration of exposure:
1
Justification:
local effect, according to ECETOC guideline
AF for interspecies differences (allometric scaling):
1
Justification:
local effect, according to ECETOC guideline
AF for other interspecies differences:
1
Justification:
no additional assessment factor required
AF for intraspecies differences:
5
Justification:
according to ECETOC guideline
AF for the quality of the whole database:
1
Justification:
no additional assessment factor required
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.3 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
15
Dose descriptor starting point:
other: LOAEL
AF for dose response relationship:
3
Justification:
extrapolation from LOAEL to NOAEL
AF for interspecies differences (allometric scaling):
1
Justification:
local effect, according to ECETOC guideline
AF for other interspecies differences:
1
Justification:
no additional assessment factor required
AF for intraspecies differences:
5
Justification:
according to ECETOC guideline
AF for the quality of the whole database:
1
Justification:
no additional assessment factor required
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.07 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
28 800
Modified dose descriptor starting point:
LOAEL
Value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
not applicable, as starting point is oral toxicity study.
AF for dose response relationship:
8
Justification:
LOAEL based on clinical signs observed in an acute dermal toxicity study
AF for differences in duration of exposure:
18
Justification:
assuming chronic exposure of the general population
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
1
Justification:
according to ECETOC guideline
AF for intraspecies differences:
5
Justification:
according to ECETOC guideline
AF for the quality of the whole database:
10
Justification:
Acute studies available only
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