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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2.42 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):
250
Modified dose descriptor starting point:
NOAEC
Value:
605 mg/m³
Explanation for the modification of the dose descriptor starting point:
See page 21 of the Guidance on Information Requirements and Chemical Safety Assessment Chapter R8.
AF for differences in duration of exposure:
5
Justification:
54d study
AF for interspecies differences (allometric scaling):
1
Justification:
rat, but inhalation study, so no allometric scaling
AF for other interspecies differences:
2.5
Justification:
standard according to ECHA guidance
AF for intraspecies differences:
5
Justification:
workers
AF for the quality of the whole database:
4
Justification:
Read Across study
Acute/short term exposure
Hazard assessment conclusion:
high 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:
high hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
686 µg/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):
1 000
Modified dose descriptor starting point:
NOAEL
Value:
686 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
See page 21 of the Guidance on Information Requirements and Chemical Safety Assessment Chapter R8.
AF for differences in duration of exposure:
5
Justification:
54d study
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
standard according to ECHA guidance
AF for intraspecies differences:
5
Justification:
workers
AF for the quality of the whole database:
4
Justification:
Read across study
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
Most sensitive endpoint:
skin irritation/corrosion

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:
DNEL (Derived No Effect Level)
Value:
596 µg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
500
Modified dose descriptor starting point:
NOAEC
Value:
298 mg/m³
Explanation for the modification of the dose descriptor starting point:
See page 21 of the Guidance on Information Requirements and Chemical Safety Assessment Chapter R8.
AF for differences in duration of exposure:
5
Justification:
54d study
AF for interspecies differences (allometric scaling):
1
Justification:
rat, but inhalation, so no allometric scaling
AF for other interspecies differences:
2.5
Justification:
standard according to ECHA guidance
AF for intraspecies differences:
10
Justification:
consumers
AF for the quality of the whole database:
4
Justification:
Read Across study
Acute/short term exposure
Hazard assessment conclusion:
high 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:
high hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
343 µg/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):
2 000
Modified dose descriptor starting point:
NOAEL
Value:
686 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
See page 21 of the Guidance on Information Requirements and Chemical Safety Assessment Chapter R8.
AF for differences in duration of exposure:
5
Justification:
45d study
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
standard according to ECHA guidance
AF for intraspecies differences:
10
Justification:
consumers
AF for the quality of the whole database:
4
Justification:
Read Across study
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
343 µg/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):
2 000
Modified dose descriptor starting point:
NOAEL
Value:
686 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
See page 21 of the Guidance on Information Requirements and Chemical Safety Assessment Chapter R8.
AF for differences in duration of exposure:
5
Justification:
45d study
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
standard according to ECHA guidance
AF for intraspecies differences:
10
Justification:
consumers
AF for the quality of the whole database:
4
Justification:
Read Across study
Acute/short term exposure
Hazard assessment conclusion:
low 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