Registration Dossier

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:
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

The substance is not acutely toxic via the oral or dermal routes (LD50 > 2000 mg ai/kg bw) and oral administration of test item to rats by gavage, at dose levels of 59, 177, 295, and 590 mg ai/kg bw/day, was well tolerated in a combined 28-day repeated dose oral toxicity study with reproductive/developmental toxicity screening (NOAEL reported as 1000 mg/kg bw/day, the highest test item dose evaluated). Moreover, no evidence of skin irritation/corrosion, serious eye damage/irritation or skin sensitisation was found during performance of appropriate studies.In the absence of systemic or local effects by the oral or dermal route, appropriate DNELs could not be 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:
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

The substance is not acutely toxic via the oral or dermal routes (LD50 > 2000 mg ai/kg bw) and oral administration of test item to rats by gavage, at dose levels of59, 177, 295, and 590 mg ai/kg bw/day, was well tolerated in a combined 28-day repeated dose oral toxicity study with reproductive/developmental toxicity screening (NOAEL reported as 1000 mg/kg bw/day, the highest test item dose evaluated). Moreover, no evidence of skin irritation/corrosion, serious eye damage/irritation or skin sensitisation was found during performance of appropriate studies. In the absence of systemic or local effects by the oral or dermal route, appropriate DNELs could not be derived.