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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.41 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
Value:
10.33 mg/m³
Explanation for the modification of the dose descriptor starting point:
according to acute inhalation study, technically achievable concentration is limited to 4,62 mg/m3. No effect was observed in the range from 0 to 4,62 mg/m3
AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic extrapolation according to ECHA guidance R8
AF for interspecies differences (allometric scaling):
1
Justification:
rat to human difference according to ECHA guidance R8
AF for other interspecies differences:
1
Justification:
no other differences identified
AF for intraspecies differences:
5
Justification:
worker factor according to ECHA guidance R8
AF for the quality of the whole database:
1
Justification:
expert judgement according to ECHA guidelines R8
AF for remaining uncertainties:
2.5
Justification:
according to ECHA guidance R8
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.82 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):
12.5
DNEL extrapolated from long term DNEL
Modified dose descriptor starting point:
NOAEC
Value:
10.33 mg/m³
Explanation for the modification of the dose descriptor starting point:
From acute inhalation study concentration is technically limited to 4,62 ,mg/m3. No effect was observed in the range from 0 to 4,62 mg/m3
AF for dose response relationship:
1
AF for interspecies differences (allometric scaling):
1
Justification:
rat to human difference according to ECHA guidance R8
AF for other interspecies differences:
1
Justification:
no other differences identified
AF for intraspecies differences:
5
Justification:
worker factor according to ECHA guidance R8
AF for the quality of the whole database:
1
Justification:
expert judgement according to ECHA guidelines R8
AF for remaining uncertainties:
2.5
Justification:
according to ECHA guidance R8

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
11.91 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
84
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
not applied
AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic extrapolation according to ECHA guidance r8
AF for interspecies differences (allometric scaling):
2.4
Justification:
rabbit to human difference according to ECHA guidance
AF for other interspecies differences:
1
Justification:
no further differences discovered
AF for intraspecies differences:
5
Justification:
worker factor according to ECHA guidance
AF for the quality of the whole database:
1
Justification:
expert judgement according to ECHA guidelines
AF for remaining uncertainties:
3.5
Justification:
general uncertainties according to ECHA guidance r8 = 2.5; worker 5 days vs. exposure 7 day in study = 1.4
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
23.8 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
42
DNEL extrapolated from long term DNEL
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
not applied
AF for dose response relationship:
1
AF for interspecies differences (allometric scaling):
2.4
Justification:
rabbit to human difference according to ECHA guidance
AF for other interspecies differences:
1
Justification:
no further differences discovered
AF for intraspecies differences:
5
Justification:
worker factor according to ECHA guidance
AF for the quality of the whole database:
1
Justification:
expert judgement according to ECHA guidelines
AF for remaining uncertainties:
3.5
Justification:
general uncertainities according to ECHA guidance r8 = 2.5; worker 5 days vs. exposure 7 day in study = 1.4

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

Exposure by inhalation and dermal contact is expected only for exposure scenario 1 (formulation of preparations starting with undiluted Fluometuron powder)

DNEL – short-term, Worker

The calculations for the long term DNELs for workers are based on a 90-day oral feeding study performed in Fischer 344 rats. The NOAEL in this study was found to be 5.9 mg/kg bw/d. This value was used as basis for DNEL calculation. Route-to-route extrapolation (oral to inhalative) was performed according to the ECHA Guidance Document R.8. Additional sub-chronic studies can be avoided as in acute inhalation study no critical effect was observed. Test animals were exposed on 7 days a week. For workers, the expected exposure is only 5 days a week. Therefore, a factor of 7/5 was introduced for workers due to the exposure pattern (working time of 5 days a week).

DNEL –long-term, Worker

The long-term DNELs for worker are based on the same subchronic NOAEL as the short-term DNELs. Therefore, an additional AF of 2 is applied to account for assessing chronic exposures with subchronic study data. Thus, the long-term DNELs are half as high as the short-term DNELs. In respect to eye exposure slightly irritating properties were found, not sufficient for classification. Nevertheless This may be taken into account were exposure with high dust emissions is occurring.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
no hazard identified
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:
no hazard identified
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

No exposure of Fluometuron for general population is expected. Direct use or indirect poisoning can be exclude.