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:
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/kg bw) and oral administration of test item to rats by gavage, at dose levels of30, 300 and 1000 mg/kg bw/day, was well tolerated in a 28-day repeated dose oral toxicity study (OECD 407) and a reproductive/developmental toxicity screening study (OECD 421). The NOAEL was reported in both instances 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, 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/kg bw) and oral administration of test item to rats by gavage, at dose levels of30, 300 and 1000 mg/kg bw/day, was well tolerated in a 28-day repeated dose oral toxicity study (OECD 407) and a reproductive/developmental toxicity screening study (OECD 421). The NOAEL was reported in both instances 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, appropriate DNELs could not be derived.