Registration Dossier
Registration Dossier
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EC number: 413-060-1 | CAS number: 19186-97-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 95 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 253.4 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEC
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 95 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 100
- Dose descriptor:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 253.4 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEC
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 13.6 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 40 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.17 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 40
- Dose descriptor:
- other: NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 mg/cm²
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 20
- Dose descriptor starting point:
- other: NOAEL
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
DNEL values for workers were calculated for dermal and inhalation routes of exposure. Penetration of FR-370 through these routes is assumed to be negligible owing to the high molecular weight above 1000g/mol, the Log Pow value above 4 and the very poor solubility in water (0.0156 mg/L), (Guidance on Information Requirements and Chemical Safety Assessment, (Chapter R.7C paragraph R.7.12).
Skin route
In addition to the above argumentation, FR-370 was found to be not irritating to skin and eye, not sensitizing to skin and showed skin LD50>2000 mg/kg bw with no systemic toxicity or any other toxicity. Therefore, it is unlikely that exposure of workers via the dermal route will be harmful. Nevertheless, in order to avoid any potential exposure, workers are instructed to wear protective gloves, body covering clothes and boots.
Inhalation route
Although FR-370 contains an inhalable fraction of particles, it is not expected to be absorbed or cause toxicity or any adverse effect via inhalation owing to its properties. In addition, the respiratory system was not found to be a target in both the 90 days oral repeated dose study or in the ADME study.
In summary, the above arguments indicate that the substance is unlikely to be available to workers through the dermal route or inhalation route. The risk management measures provided in Part A are sufficient for safe use by workers.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 47.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 126.7 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEC
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 47.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 200
- Dose descriptor:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 126.7 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEC
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.79 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 20 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.17 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 80
- Dose descriptor:
- other: NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 mg/cm²
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 40
- Dose descriptor starting point:
- other: NOAEL
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.79 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 50 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
DNEL values for general population were calculated for dermal and inhalation routes of exposure. Penetration of FR-370 through these routes is assumed to be negligible owing to the high molecular weight above 1000g/mol, the Log Pow value above 4 and the very poor solubility in water (0.0156 mg/L), (Guidance on Information Requirements and Chemical Safety Assessment, (Chapter R.7C paragraph R.7.12).
Oral route
The results from the ADME study and 90-day repeat dose oral toxicity study further support the above argumentation, showing very low absorption and retention of FR-370 in tissues (2%) and no systemic toxic effects above 1000mg/kg (highest dose level tested).
Skin route
FR-370 was found to be not irritating to skin and eye, not sensitizing to skin and showed skin LD50>2000 mg/kg bw with no systemic toxicity or any other toxicity. Therefore, it is unlikely that exposure of general population via the dermal route will be harmful.
Inhalation route
Although FR-370 contains an inhalable fraction of particles, it is not expected to be absorbed or cause toxicity or any adverse effect via inhalation. In addition, the respiratory system was not found to be a target in both the 90 days oral repeated dose study or in the ADME study.
In summary, the above arguments indicate that the substance is unlikely to be available forgeneral populationthrough the oral route, dermal route or inhalation route.
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