Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.411 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
Dose descriptor starting point:
NOAEL
Value:
20 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
35.26 mg/m³
Explanation for the modification of the dose descriptor starting point:

Correction: 20 / (0,380 *(10 / 6,7)) =35,26 mg/m3

(Transformation from oral to inhalation & Comp. for Route & Comp. for increased respiratory rate for workers)

AF for dose response relationship:
1
Justification:
ECHA default
AF for differences in duration of exposure:
2
Justification:
Based on subchronic toxicity study
AF for interspecies differences (allometric scaling):
2.5
Justification:
ECHA default
AF for other interspecies differences:
1
Justification:
Allometric scaling factor is already in route-to-route extrapolation
AF for intraspecies differences:
5
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
Study of sufficient quality
AF for remaining uncertainties:
1
Justification:
No indication that a factor is needed
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
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:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.4 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
Dose descriptor starting point:
NOAEL
Value:
20 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
40 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Correction for route-to-route extrapolation (50% absorption by skin versus 100% by oral route)

AF for dose response relationship:
1
Justification:
ECHA default
AF for differences in duration of exposure:
2
Justification:
Based on subchronic toxicity study
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
5
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
Study of sufficient quality
AF for remaining uncertainties:
1
Justification:
No indication that a factor is needed
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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Oral toxicity data were available for Fenuron. A subacute toxicity test was waived due to presence of an appropriate subchronic toxicity study in rats dosed for 90 days by oral gavage at doses of 20, 100 and 500 mg/kg bw/d. At 500 mg/kg bw, slight reduction in body weight gain was observed in both sexes. Clinical-chemical findings were seen at 100 and 500 mg/kg bw/d (increased serum alkaline phosphatase, alanine aminotransferase, leucine aminopeptidase and cholesterol; decreased serum cholinesterase and glucose). Increased absolute and relative liver weights were observed at 100 and 500 mg/kg bw/d and decreased thymus weight was observed at 500 mg/kg bw/d. No histopathological findings were observed in any organs at the various doses. For Fenuron, a NOEL of 20 mg/kg bw was determined under the given experimental conditions. This value was used as departure point for DNEL derivation.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.348 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):
50
Dose descriptor starting point:
NOAEL
Value:
20 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
17.39 mg/m³
Explanation for the modification of the dose descriptor starting point:

Correction: 20 / (1,150) = 17,39 mg/m3 (Transformation from oral to inhalation & Comp. for Route)

AF for dose response relationship:
1
Justification:
ECHA default
AF for differences in duration of exposure:
2
Justification:
Based on subchronic toxicity study
AF for interspecies differences (allometric scaling):
2.5
Justification:
ECHA default
AF for other interspecies differences:
1
Justification:
Allometric scaling factor is already in route-to-route extrapolation
AF for intraspecies differences:
10
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
Study of sufficient quality
AF for remaining uncertainties:
1
Justification:
No indication that a factor is needed
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
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:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.2 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
Dose descriptor starting point:
NOAEL
Value:
20 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
40 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Correction for route-to-route extrapolation (50% absorption by skin versus 100% by oral route)

AF for dose response relationship:
1
Justification:
ECHA default
AF for differences in duration of exposure:
2
Justification:
Based on subchronic toxicity study
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
10
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
Study of sufficient quality
AF for remaining uncertainties:
1
Justification:
No indication that a factor is needed
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

General Population - Hazard via oral 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):
200
Dose descriptor starting point:
NOAEL
Value:
20 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
20 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No compensation for route.

AF for dose response relationship:
1
Justification:
ECHA default
AF for differences in duration of exposure:
2
Justification:
Based on subchronic toxicity study
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
10
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
Study of sufficient quality
AF for remaining uncertainties:
1
Justification:
No indication that a factor is needed
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

Oral toxicity data were available for Fenuron. A subacute toxicity test was waived due to presence of an appropriate subchronic toxicity study in rats dosed for 90 days by oral gavage at doses of 20, 100 and 500 mg/kg bw/d. At 500 mg/kg bw, slight reduction in body weight gain was observed in both sexes. Clinical-chemical findings were seen at 100 and 500 mg/kg bw/d (increased serum alkaline phosphatase, alanine aminotransferase, leucine aminopeptidase and cholesterol; decreased serum cholinesterase and glucose). Increased absolute and relative liver weights were observed at 100 and 500 mg/kg bw/d and decreased thymus weight was observed at 500 mg/kg bw/d. No histopathological findings were observed in any organs at the various doses. For Fenuron, a NOEL of 20 mg/kg bw was determined under the given experimental conditions. This value was used as departure point for DNEL derivation