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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
6 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):
75
Modified dose descriptor starting point:
NOAEC
Value:
440 mg/m³
Explanation for the modification of the dose descriptor starting point:

Oral NOAEL (500 mg/kg) x 1/0.38 m³/kg x 6.7 m³/10m³ = 881 mg/m³; default oral abs: 50% and inhal. abs 100% => NOAEC = 440 mg/ m³.

AF for dose response relationship:
1
Justification:
Reach Guidance default factor
AF for differences in duration of exposure:
6
Justification:
Reach Guidance default factor for extrapolation from sub-acute to chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
Allometry included in dose descriptor starting point
AF for other interspecies differences:
2.5
Justification:
Reach Guidance default factor
AF for intraspecies differences:
5
Justification:
Reach Guidance default factor for worker
AF for the quality of the whole database:
1
Justification:
No additional factor for systemic toxicity necessary; the compound is included in the high hazard band.
AF for remaining uncertainties:
1
Justification:
No additional factor for systemic toxicity necessary; the compound is included in the high hazard band.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6 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):
75
DNEL extrapolated from long term DNEL
Modified dose descriptor starting point:
NOAEC
Value:
440 mg/m³
Explanation for the modification of the dose descriptor starting point:

See long-term systemic DNEL derivation.

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.7 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):
300
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Oral absorption is taken similar to dermal absorption (default by Reach Guidance).

AF for dose response relationship:
1
Justification:
Reach Guidance default factor; starting point NOAEL
AF for differences in duration of exposure:
6
Justification:
Reach Guidance default factor for extrapolation from sub-acute to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
default factor for extrapolation from rats to humans
AF for other interspecies differences:
2.5
Justification:
Reach Guidance default factor
AF for intraspecies differences:
5
Justification:
Reach Guidance default factor
AF for the quality of the whole database:
1
Justification:
No additional factor for systemic toxicity necessary; the compound is included in the high hazard band.
AF for remaining uncertainties:
1
Justification:
No additional factor for systemic toxicity necessary; the compound is included in the high hazard band.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.7 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):
300
DNEL extrapolated from long term DNEL
Explanation for the modification of the dose descriptor starting point:

See long-term systemic DNEL derivation.

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

According to the Reach Guidance skin senitizing compounds labelled as Skin Sens 1A according to GHS should be allocated to the high hazard band.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.4 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):
150
Modified dose descriptor starting point:
NOAEC
Value:
217 mg/m³
Explanation for the modification of the dose descriptor starting point:

Oral NOAEL (500 mg/kg) x 1/1.15 m³/kg = 434 mg/m³; default oral abs: 50% and inhal. abs 100% => NOAEC general population = 217 mg/m³.

AF for dose response relationship:
1
Justification:
Reach Guidance default factor
AF for differences in duration of exposure:
6
Justification:
Reach Guidance default factor for extrapolation from sub-acute to chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
Allometry included in dose descriptor starting point
AF for other interspecies differences:
2.5
Justification:
Reach Guidance default factor
AF for intraspecies differences:
10
Justification:
Reach Guidance default factor
AF for the quality of the whole database:
1
Justification:
No additional factor for systemic toxicity necessary; the compound is included in the high hazard band.
AF for remaining uncertainties:
1
Justification:
No additional factor for systemic toxicity necessary; the compound is included in the high hazard band.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.4 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):
150
DNEL extrapolated from long term DNEL
Modified dose descriptor starting point:
NOAEC
Value:
217 mg/m³
Explanation for the modification of the dose descriptor starting point:

See derivation of long-term DNEL.

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.8 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):
600
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Oral absorption is taken similar to dermal absorption (default by Reach Guidance).

AF for dose response relationship:
1
Justification:
Reach Guidance default factor; starting point NOAEL
AF for differences in duration of exposure:
6
Justification:
Reach Guidance default factor for extrapolation from sub-acute to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
default factor for extrapolation from rats to humans
AF for other interspecies differences:
2.5
Justification:
Reach Guidance default factor
AF for intraspecies differences:
10
Justification:
Reach Guidance default factor
AF for the quality of the whole database:
1
Justification:
No additional factor for systemic toxicity necessary; the compound is included in the high hazard band.
AF for remaining uncertainties:
1
Justification:
No additional factor for systemic toxicity necessary; the compound is included in the high hazard band.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.8 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):
600
DNEL extrapolated from long term DNEL
Explanation for the modification of the dose descriptor starting point:

See long-term systemic DNEL derivation.

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.8 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):
600
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Reach Guidance default factor; starting point NOAEL
AF for differences in duration of exposure:
6
Justification:
Reach Guidance default factor for extrapolation from sub-acute to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
default factor for extrapolation from rats to humans
AF for other interspecies differences:
2.5
Justification:
Reach Guidance default factor
AF for intraspecies differences:
10
Justification:
Reach Guidance default factor
AF for the quality of the whole database:
1
Justification:
No additional factor for systemic toxicity necessary; the compound is included in the high hazard band.
AF for remaining uncertainties:
1
Justification:
No additional factor for systemic toxicity necessary; the compound is included in the high hazard band.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.8 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):
600
DNEL extrapolated from long term DNEL
Explanation for the modification of the dose descriptor starting point:

See long-term systemic DNEL derivation.

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

According to the Reach Guidance skin senitizing compounds labelled as Skin Sens 1A according to GHS should be allocated to the high hazard band.