Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 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
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Oral to dermal extrapolation assumed to be 100%, so factor applied is 1. Absorption through skin will be lower than that via the gastrointestinal tract, hence this is worst case.
AF for differences in duration of exposure:
2
Justification:
extrapolation from sub-chronic 90d study to chronic exposure, as per guidance
AF for interspecies differences (allometric scaling):
4
Justification:
extrapolation from rat to human
AF for other interspecies differences:
2.5
Justification:
remaining differences, as per guidance R8, after allometric scaling
AF for intraspecies differences:
5
Justification:
default factor for worker population applied
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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

A worst case scenario was adopted at the route to route extrapolation stage for oral to dermal exposure. Default assessment factors were applied as stipulated in Table R.8.6 of ECHA Guidance on information requirements and chemical safety assessment Chapter R8: Characterisation of dose [concentration]-response for human health.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.5 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
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Oral to dermal extrapolation assumes 100% absorption as worst case (though true absorption is likely to be much lower), factor used is 1.
AF for differences in duration of exposure:
2
Justification:
Extrapolation from sub-chronic study to chronic exposure in man
AF for interspecies differences (allometric scaling):
4
Justification:
Extrapolation from rat to man (allometric scaling)
AF for other interspecies differences:
2.5
Justification:
Default for remaining differences (other than allometric scaling)
AF for intraspecies differences:
10
Justification:
Default value as per REACH guidance R8 for general population
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:
0.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Not required
AF for differences in duration of exposure:
2
Justification:
Extrapolation from sub-chronic study to chronic exposure in man
AF for interspecies differences (allometric scaling):
4
Justification:
Extrapolation from rat to man (allometric scaling)
AF for other interspecies differences:
2.5
Justification:
Remaining differences, default value as per R8 REACH guidance
AF for intraspecies differences:
10
Justification:
Default value for general population, as per R8, REACH guidance
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

A worst case scenario was adopted at the route to route extrapolation stage for dermal DNEL derivation. Default assessment factors were applied as stipulated in Table R.8.6 of ECHA Guidance on information requirements and chemical safety assessment Chapter R8: Characterisation of dose [concentration]-response for human health.