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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.18 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):
25
Dose descriptor starting point:
other: LOAEL mg/kg
Value:
7 mg/kg bw/day
Modified dose descriptor starting point:
other: Corrected LOAEL (mg/m3)
Value:
4.56 mg/m³
Explanation for the modification of the dose descriptor starting point:

See "Explanation for hazard conclusion" below

AF for dose response relationship:
2
Justification:
Effects noted in NTP study are considered to be minor. LOAEL to NOAEC
AF for differences in duration of exposure:
1
Justification:
UK MSA indicated that “No factor is needed for study duration”. Study duration sufficient for long term systemic effects
AF for interspecies differences (allometric scaling):
1
Justification:
not applicable - Table R. 8-4 When to apply allometric scaling (AS) factor in step c
AF for other interspecies differences:
2.5
Justification:
Table R. 8-6 Default assessment factors. Chapter R.8: Characterisation of dose [concentration]-response for human health; Pg 32.
AF for intraspecies differences:
5
Justification:
Default ECHA guidance for Worker population
AF for the quality of the whole database:
1
Justification:
ECHA guidance default
AF for remaining uncertainties:
1
Justification:
Chronic studies are available in rats and mice; most sensitive species used for point of departure
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
DNEL derivation method:
other: Not derived.

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:
0.41 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):
175
Dose descriptor starting point:
LOAEL
Value:
7 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
51.395 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

See "Explanation for hazard conclusion" below

AF for dose response relationship:
2
Justification:
Effects noted in NTP study are considered to be minor. LOAEL to NOAEL
AF for differences in duration of exposure:
1
Justification:
UK MSA indicated that “No factor is needed for study duration”. Study duration sufficient for long term systemic effects
AF for interspecies differences (allometric scaling):
7
Justification:
Table R. 8-3 Allometric scaling factors for different species as compared to humans - mouse
AF for other interspecies differences:
2.5
Justification:
Table R. 8-6 Default assessment factors. Chapter R.8: Characterisation of dose [concentration]-response for human health; Pg 32.
AF for intraspecies differences:
5
Justification:
intraspecies – workers
AF for the quality of the whole database:
1
Justification:
quality of database
AF for remaining uncertainties:
1
Justification:
Chronic studies are available in rats and mice; most sensitive species used for point of departure
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
DNEL derivation method:
other: not derived

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
DNEL derivation method:
other: Not derived

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low 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:
0.03 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):
50
Dose descriptor starting point:
other: LOAEL mg/kg
Value:
7 ng/m³
Modified dose descriptor starting point:
LOAEC
Value:
1.63 mg/m³
Explanation for the modification of the dose descriptor starting point:

See "Explanation for hazard conclusion" below

AF for dose response relationship:
2
Justification:
Effects noted in NTP study are considered to be minor. LOAEL to NOAEL
AF for differences in duration of exposure:
1
Justification:
UK MSA indicated that “No factor is needed for study duration”. Study duration sufficient for long term systemic effects
AF for interspecies differences (allometric scaling):
1
Justification:
not applicable - Table R. 8-4 When to apply allometric scaling (AS) factor in step c. Covered in corrected LOAEL derivation
AF for other interspecies differences:
2.5
Justification:
Table R. 8-6 Default assessment factors. Chapter R.8: Characterisation of dose [concentration]-response for human health; Pg 32.
AF for intraspecies differences:
10
Justification:
Default ECHA guidance for Consumer population
AF for the quality of the whole database:
1
Justification:
Quality of the database
AF for remaining uncertainties:
1
Justification:
Chronic studies are available in rats and mice; most sensitive species used for point of departure
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
DNEL derivation method:
other: not derived

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:
0.15 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):
350
Dose descriptor starting point:
LOAEL
Value:
7 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
51.395 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

See "Explanation for hazard conclusion" below

AF for dose response relationship:
2
Justification:
Effects noted in NTP study are considered to be minor. LOAEL to NOAEL
AF for differences in duration of exposure:
1
Justification:
UK MSA indicated that “No factor is needed for study duration”. Study duration sufficient for long term systemic effects
AF for interspecies differences (allometric scaling):
7
Justification:
Table R. 8-3 Allometric scaling factors for different species as compared to humans - mouse
AF for other interspecies differences:
2.5
Justification:
Table R. 8-6 Default assessment factors. Chapter R.8: Characterisation of dose [concentration]-response for human health; Pg 32.
AF for intraspecies differences:
10
Justification:
Default ECHA guidance for Consumer population
AF for the quality of the whole database:
1
Justification:
quality of the database
AF for remaining uncertainties:
1
Justification:
Chronic studies are available in rats and mice; most sensitive species used for point of departure
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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.02 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):
350
Dose descriptor starting point:
LOAEL
Value:
7 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
7 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

See "Explanation for hazard conclusion" below

AF for dose response relationship:
2
Justification:
Effects noted in NTP study are considered to be minor. LOAEL to NOAEL
AF for differences in duration of exposure:
1
Justification:
UK MSA indicated that “No factor is needed for study duration”. Study duration sufficient for long term systemic effects
AF for interspecies differences (allometric scaling):
7
Justification:
Table R. 8-3 Allometric scaling factors for different species as compared to humans. Mouse is given as 7
AF for other interspecies differences:
2.5
Justification:
Table R. 8-6 Default assessment factors. Chapter R.8: Characterisation of dose [concentration]-response for human health; Pg 32.
AF for intraspecies differences:
10
Justification:
Default ECHA guidance for Consumer population
AF for the quality of the whole database:
1
Justification:
quality of database
AF for remaining uncertainties:
1
Justification:
Chronic studies are available in rats and mice; most sensitive species used for point of departure
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population