Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.3 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC Technical Report No. 110_Page 62
Overall assessment factor (AF):
160
Modified dose descriptor starting point:
LOAEC
Value:
42 mg/m³
Explanation for the modification of the dose descriptor starting point:
Comparable resorption for oral and inhalation routes; Human body weight of 70kg/person; Daily respration volume of 10 m³ for a worker for 8 hours.
AF for dose response relationship:
10
Justification:
No NOAEL could be established and the LOAEL is used as the base for the DNEL derivation. The effect at LOAEL was limited to reduced spleen weight of fetuses, therefore the use of 2 as additional factor is considered to be appropriate.
AF for differences in duration of exposure:
1
Justification:
The exposure duration covered the entire second and the third trimester of the pregnancy.
AF for interspecies differences (allometric scaling):
4
Justification:
The allometric scaling factor of rat is given as 4 in ECHA REACH Guidance
AF for other interspecies differences:
10
Justification:
According to the ECETOC Technical Report No. 110_Page 62
AF for intraspecies differences:
1
Justification:
According to the ECETOC Technical Report No. 110_Page 62
AF for the quality of the whole database:
1
Justification:
All data are Klinish 1 or 2.
AF for remaining uncertainties:
2
Justification:
The assessment is based on the read-across.
Acute/short term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
0.3 mg/m³
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
0.3 mg/m³
Acute/short term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
0.3 mg/m³
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.04 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC Technical Report No. 110_Page 62
Overall assessment factor (AF):
160
Modified dose descriptor starting point:
LOAEL
Value:
6 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Comparable resorption for oral and dermal routes; Human body weight of 70kg/person;
AF for dose response relationship:
10
Justification:
No NOAEL could be established and the LOAEL is used as the base for the DNEL derivation. THe effect at LOAEL was limited to reduced spleen weight of fetuses, therefore the use of 2 as additional factor is considered to be appropriate.
AF for differences in duration of exposure:
1
Justification:
The exposure duration covered the entire second and third trimester of the pregnancy.
AF for interspecies differences (allometric scaling):
4
Justification:
The allometric scaling factor of rat is given as 4 in ECHA REACH Guidance
AF for other interspecies differences:
10
Justification:
According to the ECETOC Technical Report No. 110_Page 62
AF for intraspecies differences:
1
Justification:
According to the ECETOC Technical Report No. 110_Page 62
AF for the quality of the whole database:
1
Justification:
All data are Klinish 1 or 2.
AF for remaining uncertainties:
2
Justification:
The assessment is based on the read-across.
Acute/short term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
0.04 mg/kg bw/day
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:
medium hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
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
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
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:
other toxicological threshold
Value:
1.5 µg/kg bw/day
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population