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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
8.8 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):
114
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
AF for differences in duration of exposure:
2
Justification:
exposure duration default, sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling from rat to human
AF for other interspecies differences:
2.5
Justification:
inter-specific correction
AF for remaining uncertainties:
0.57
Justification:
difference in respiratory volumes
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
35.08 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
57
Dose descriptor starting point:
other: acute toxicity study
Value:
2 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
AF for interspecies differences (allometric scaling):
2.5
Justification:
inter-specific correction for meatabolic rate
AF for intraspecies differences:
5
Justification:
for worker
AF for remaining uncertainties:
0.57
Justification:
difference in respiratory volumes

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:
10 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:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
AF for differences in duration of exposure:
2
Justification:
exposure duration default, sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling from rat to human
AF for other interspecies differences:
2.5
Justification:
inter-specific correction for meataboli rate
AF for intraspecies differences:
5
Justification:
intra-species, worker
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
170 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Dose descriptor starting point:
other: Acute toxicity study LD50
Value:
2 000 mg/kg bw/day
Modified dose descriptor starting point:
other: LD50
AF for other interspecies differences:
2.5
Justification:
default value for inter-specific effects
AF for intraspecies differences:
5
Justification:
intra-specific for worker
AF for the quality of the whole database:
1

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

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.69 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):
115
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
AF for differences in duration of exposure:
2
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling from rat to human
AF for other interspecies differences:
2.5
Justification:
correction for metabolic rate
AF for intraspecies differences:
10
Justification:
inter-species, general population
AF for remaining uncertainties:
1.15
Justification:
difference in respiratory volume
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.7 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):
230
Dose descriptor starting point:
other: Acute toxicity LD50
Value:
2 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
AF for interspecies differences (allometric scaling):
2.5
Justification:
default
AF for intraspecies differences:
10
Justification:
intra-specific for general population

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:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
400
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
10
Justification:
inter-species, general population
AF for other interspecies differences:
4
Justification:
allometric scaling from rat to human
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
80 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
other: Acute toxicity LD50
Value:
2 000 mg/kg bw/day
Modified dose descriptor starting point:
other: acute study
AF for other interspecies differences:
2.5
Justification:
remaining inter-specific differences
AF for intraspecies differences:
10
Justification:
intra-specific for general population

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:
5 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:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for other interspecies differences:
10
Justification:
inter-species, general population
AF for remaining uncertainties:
2.5
Justification:
correction for metabolic rate
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
80 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
other: acute study
Value:
2 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
AF for other interspecies differences:
2.5
Justification:
remaining inter-specific differences
AF for intraspecies differences:
10
Justification:
intra-specific for general population

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population