Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.88 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
30
Modified dose descriptor starting point:
NOAEC
Value:
176 mg/m³
Explanation for the modification of the dose descriptor starting point:
Inhalation toxicity test is not available.
AF for dose response relationship:
1
Justification:
The initial value is NOAEL.
AF for differences in duration of exposure:
6
Justification:
The initial end-point is based on Reproduction/Developmental Toxicity Screening Test. Duration exposure in this test is 25-28 days, it means same period as sub-acute test.
AF for interspecies differences (allometric scaling):
1
Justification:
Corrected NOAEC was derived for human, it means that interspecies differences are included.
AF for other interspecies differences:
1
Justification:
There are not known any information shows specific susceptibility differences between species.
AF for intraspecies differences:
5
Justification:
DNEL is derived for workers.
AF for the quality of the whole database:
1
Justification:
Reliability of the original study is 1.
AF for remaining uncertainties:
1
Justification:
There are not known any information about other uncertainties.
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.83 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Dermal toxicity test is not available.
AF for dose response relationship:
1
Justification:
The initial value is NOAEL.
AF for differences in duration of exposure:
6
Justification:
The initial end-point is based on Reproduction/Developmental Toxicity Screening Test. Duration exposure in this test is 25-28 days, it means same period as sub-acute test.
AF for interspecies differences (allometric scaling):
4
Justification:
The test was performed on rats.
AF for other interspecies differences:
1
Justification:
There are not known any information shows specific susceptibility differences between species.
AF for intraspecies differences:
5
Justification:
DNEL is derived for workers.
AF for the quality of the whole database:
1
Justification:
Reliability of the original study is 1.
AF for remaining uncertainties:
1
Justification:
There are not known any information about other uncertainties.
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
60.4 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
105
Dose descriptor:
other: LOAEL
AF for dose response relationship:
3
Justification:
The initial value is LOAEL.
AF for differences in duration of exposure:
1
Justification:
The test time corresponds to the methodology.
AF for interspecies differences (allometric scaling):
7
Justification:
The skin sensitisation test (LLNA) was carried out on mice.
AF for other interspecies differences:
1
Justification:
There are not known any information shows specific susceptibility differences between species.
AF for intraspecies differences:
5
Justification:
DNEL is derived for workers.
AF for the quality of the whole database:
1
Justification:
Reliability of the original study is 1.
AF for remaining uncertainties:
1
Justification:
There are not known any information about other uncertainties.

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

DNEL for dermal and inhalation long-term systemic exposure was derived from Reproduction/Developmental Toxicity Screening Test according to Chapter R.8 Guidance on information requirements and chemical safety assessment. This NOAEL for male fertility seems to be the most sensitive end-point.

DNEL dermal long-term systemic exposure was derived on the basis of Skin sensitisation LLNA test from EC3 value according to Chapter R.8 Guidance on information requirements and chemical safety assessment.

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

Exposure of general population is not expected.