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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
68.34 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
other: ECHA REACH guidance procedure but incorporating ECETOC intraspecies AF
Overall assessment factor (AF):
7.5
Dose descriptor starting point:
other: NOEL
Value:
125 mg/kg bw/day
Modified dose descriptor starting point:
other: NOEL
Value:
512.5 mg/m³
Explanation for the modification of the dose descriptor starting point:

Starting point NOEL = 125 mg/kg (rat dermal developmental tox study); [1/0.43 {RVM}] x [1/0.38{ convert to inhal dose}] x [6.7/10 {adjustment for ligh exercise}] = 512 mg/m3

AF for dose response relationship:
1
Justification:
Not required: starting point was a NOEL
AF for differences in duration of exposure:
1
Justification:
Not required
AF for interspecies differences (allometric scaling):
1
Justification:
Not required
AF for other interspecies differences:
2.5
Justification:
Interspecies rat to human (R8 guidance)
AF for intraspecies differences:
3
Justification:
ECETOC Intrapsecies AF
AF for the quality of the whole database:
1
Justification:
Reliable study available
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4 288 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: ECHA REACH guidance procedure but incorporating ECETOC intraspecies AF
Overall assessment factor (AF):
7.5
Dose descriptor starting point:
other: NOEC
Value:
6 000 mg/m³
Modified dose descriptor starting point:
other: NOEC
Value:
32 160 mg/m³
Explanation for the modification of the dose descriptor starting point:

Starting point NOEC = 6,000 mg/m3 (rat acute study); 120 minutes/day, adjusted for duration of work [120/15 {minutes/day}] x [6.7/10 {light work ventilation rate}] = 32,160 mg/m3

AF for dose response relationship:
1
Justification:
Not required: Starting point was a NOEC
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not required
AF for other interspecies differences:
2.5
Justification:
Interspecies rat to human (R8 guidance)
AF for intraspecies differences:
3
Justification:
ECETOC intraspecies AF
AF for the quality of the whole database:
1
Justification:
Reliable study available
AF for remaining uncertainties:
1
Justification:
Not required

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:
2.91 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
other: ECHA REACH guidance procedure but incorporating ECETOC intraspecies AF
Overall assessment factor (AF):
24
Dose descriptor starting point:
NOAEL
Value:
30 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
69.8 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point NOAEL [1/0.43] {Adjust the human dermal uptake to rat with adjustment factor of 0.43 to account for increased rat absorption}]

AF for dose response relationship:
1
Justification:
Not required, starting point was a NOAEL
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic (ECHA R.8 guidance)
AF for interspecies differences (allometric scaling):
4
Justification:
Interspecies rat to human (R8 guidance)
AF for other interspecies differences:
1
Justification:
Not required
AF for intraspecies differences:
3
Justification:
ECETOC intraspecies AF
AF for the quality of the whole database:
1
Justification:
Reliable study available
AF for remaining uncertainties:
1
Justification:
Not required
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

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:
20.22 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
other: ECHA REACH guidance procedure but incorporating ECETOC intraspecies AF
Overall assessment factor (AF):
12.5
Dose descriptor starting point:
other: NOEL
Value:
125 mg/kg bw/day
Modified dose descriptor starting point:
other: NOEL
Value:
252.8 mg/m³
Explanation for the modification of the dose descriptor starting point:

Starting point NOEL = 125 mg/kg (rat dermal development tox study); x [1/0.43 {for RVM}] x [1/1.15 {convert to inhal dose}] = 252 mg/m3

AF for dose response relationship:
1
Justification:
Not required, starting point was a NOEL
AF for differences in duration of exposure:
1
Justification:
Not required
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not required
AF for other interspecies differences:
2.5
Justification:
Interspecies rat to human (R8 guidance)
AF for intraspecies differences:
5
Justification:
ECETOC intraspecies AF
AF for the quality of the whole database:
1
Justification:
Reliable study available
AF for remaining uncertainties:
1
Justification:
Not required
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2 572.8 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: ECHA REACH guidance procedure but incorporating ECETOC intraspecies AF
Overall assessment factor (AF):
12.5
Dose descriptor starting point:
other: NOEC
Value:
6 000 mg/m³
Modified dose descriptor starting point:
other: NOEC
Value:
32 160 mg/m³
Explanation for the modification of the dose descriptor starting point:

Starting point NOEC = 6,000 mg/m3 (rat acute study); 120 minutes/day, adjusted for duration of work [120/15 {minutes/day}] x [6.7/10 {light work ventilation rate}] = 32,160 mg/m3

AF for dose response relationship:
1
Justification:
Not required: Starting point was a NOEC
AF for interspecies differences (allometric scaling):
1
Justification:
Not required
AF for other interspecies differences:
2.5
Justification:
Interspecies rat to human (R8 guidance)
AF for intraspecies differences:
5
Justification:
ECETOC intraspecies AF
AF for the quality of the whole database:
1
Justification:
Reliable study available
AF for remaining uncertainties:
1
Justification:
Not required

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:
1.25 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
other: ECHA REACH guidance procedure but incorporating ECETOC intraspecies AF
Overall assessment factor (AF):
40
Dose descriptor starting point:
NOAEL
Value:
30 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
49.8 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point NOAEL= 30 mg/Kg, (90 day dermal rat  study); 5 days/wk adjusted for duration of exposure [5/7{days/week} x 1/0.43 {animal absorption factor} = 49.9 mg/kg bw/day

AF for dose response relationship:
1
Justification:
Not required: starting point was a NOAEL
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic (ECHA R.8 guidance)
AF for interspecies differences (allometric scaling):
4
Justification:
Interspecies rat to human (R.8 guidance)
AF for other interspecies differences:
1
Justification:
Not required
AF for intraspecies differences:
5
Justification:
ECETOC intraspecies AF
AF for the quality of the whole database:
1
Justification:
Reliable study available
AF for remaining uncertainties:
1
Justification:
Not required
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.25 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
other: ECHA REACH guidance procedure but incorporating ECETOC intraspecies AF
Overall assessment factor (AF):
40
Dose descriptor starting point:
NOAEL
Value:
30 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
49.8 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point NOAEL= 30 mg/Kg, (90 day dermal rat  study); 5 days/wk adjusted for duration of exposure [5/7{days/week}] x [1/0.43 {animal absorption factor}] = 49.9 mg/kg bw/day

AF for dose response relationship:
1
Justification:
Not required: starting point was a NOAEL
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic (ECHA R.8 guidance)
AF for interspecies differences (allometric scaling):
4
Justification:
Interspecies rat to human (R.8 guidance)
AF for other interspecies differences:
1
Justification:
Not required
AF for intraspecies differences:
5
Justification:
ECETOC intraspecies AF
AF for the quality of the whole database:
1
Justification:
Reliable study available
AF for remaining uncertainties:
1
Justification:
Not required
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