Registration Dossier

Diss Factsheets

Administrative data

Workers - 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

Workers - 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:
DNEL (Derived No Effect Level)
Value:
199.8 µg/cm²
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

The substance is not acutely toxic via the oral or dermal routes (LD50 > 2000 mg/kg) and oral administration of test item to rats by gavage, at dose levels of 100, 300 and 750 mg/kg bw/day, was well tolerated in a 28-day repeated dose oral toxicity (NOAEL 750 mg/kg bw/day). Similar results were obtained during a reproductive/developmental screening study in which no substance-related effects relevant to humans were reported after administration of 100, 300 and 750 mg/kg bw/day (NOEL 100 mg/kg bw/day due to equivocal results for reproductive toxicity). No evidence of skin irritation/corrosion, serious eye damage/irritation was identified but the substance is classified as a skin sensitiser (1B) and an appropriate long-term local DNEL has been derived.

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:
DNEL (Derived No Effect Level)
Value:
199.8 µg/cm²
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term

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

The substance is not acutely toxic via the oral or dermal routes (LD50 > 2000 mg/kg) and oral administration of test item to rats by gavage, at dose levels of 100, 300 and 750 mg/kg bw/day, was well tolerated in a 28-day repeated dose oral toxicity (NOAEL 750 mg/kg bw/day). Similar results were obtained during a reproductive/developmental screening study in which no substance-related effects relevant to humans were reported after administration of 100, 300 and 750 mg/kg bw/day (NOEL 100 mg/kg bw/day due to equivocal results for reproductive toxicity). No evidence of skin irritation/corrosion, serious eye damage/irritation was identified but the substance is classified as a skin sensitiser (1B) and an appropriate long-term local DNEL has been derived.

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