Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
11.57 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
75
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
33.3 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available

Workers - Hazard for the eyes

Additional information - workers

Generally the toxicity of FAT 40841/A TE is very low. No mortality was seen in acute toxicity studies in rats (oral and dermal) and the NOAEL in the subacute oral study in rats was >= 1000 mg/kg bw. In a developmental toxicity/teratogenicity study according to OECD 414 no major toxicological findings in females and fetuses were noted.

FAT 40841/A TE is classified to have irreversible effects to the eye. As no dose-response data is available from the respective study (OECD 405) a DNEL cannot be derived.

The test item is a skin sensitizer. As at all tested doses the EC3 is surpassed by at least a factor of 1.5 and as an inverse dose-response was found, a quantitative derivation of a DNEL based on this endpoint is not possible.

Accordingly suitable risk management measures to protect from exposure to the eyes and the skin should be implemented.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.89 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
150
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
16.7 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.67 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

Generally the toxicity of FAT 40841/A TE is very low. No mortality was seen in acute toxicity studies in rats (oral and dermal) and the NOAEL in the subacute oral study in rats was >= 1000 mg/kg bw. In a developmental toxicity/teratogenicity study according to OECD 414 no major toxicological findings in females and fetuses were noted.

FAT 40841/A TE is classified to have irreversible effects to the eye. As no dose-response data is available from the respective study (OECD 405) a DNEL cannot be derived.

The test item is a skin sensitizer. As at all tested doses the EC3 is surpassed by at least a factor of 1.5 and as an inverse dose-response was found, a quantitative derivation of a DNEL based on this endpoint is not possible.

Accordingly suitable risk management measures to protect from exposure to the eyes and the skin should be implemented.