Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.353 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
Modified dose descriptor starting point:
NOAEC
DNEL value:
8.82 mg/m³
Explanation for the modification of the dose descriptor starting point:
ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8
AF for dose response relationship:
1
Justification:
NOAEL, not LOAEL was used as the starting point for derivation of DNEL
AF for differences in duration of exposure:
2
Justification:
Difference between subchronic and chronic exposure was cosidered.
AF for interspecies differences (allometric scaling):
1
Justification:
Differences in metabolic rate were already taken into consideration during modification of the NOAEC to the correct starting point
AF for other interspecies differences:
2.5
Justification:
Additional factor for considering remaining uncertainties during interspecies extrapolations
AF for intraspecies differences:
5
Justification:
Default is 5 for workers population, otherwise 10
AF for the quality of the whole database:
1
Justification:
Reliability of data is high (1)
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties considered.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information

Local effects

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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.1 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
DNEL value:
10 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8.
AF for dose response relationship:
1
Justification:
NOAEL, not LOAEL was used as the starting point for derivation of DNEL
AF for differences in duration of exposure:
2
Justification:
Difference between subchronic and chronic exposure was cosidered.
AF for interspecies differences (allometric scaling):
4
Justification:
Differences in metabolic rate were considered.
AF for other interspecies differences:
2.5
Justification:
Additional factor for considering remaining uncertainties during interspecies extrapolations
AF for intraspecies differences:
5
Justification:
Default is 5 for workers population, otherwise 10
AF for the quality of the whole database:
1
Justification:
Reliability of data is high (1)
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties considered.
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

Based on the results from available studies, for workers, the most sensitive endpoints were general toxicity with endpoint-specific worker-DNELlong-termequal to 0.1 mg/kg bw/day for dermal route of exposure and 0.39 mg/m3for inhalatory exposure.

DNEL(s) derivations were performed in accordance with the requirements of the ECHA Guidance on

Information Requirements and Chemical Safety Assessment, Chapter R.8: Characterization of dose [concentration]-response for human health.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population