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 registered substance is not acutely toxic via the oral route and investigation of an analogue substance via the dermal route gave the same conclusion (LD50 > 2000 mg/kg). Oral administration of an analogue test item to rats by gavage, at dose levels of 30, 100, 250 and 1000 mg/kg bw/day, was well tolerated in two subacute studies (28-day repeated dose oral toxicity and 28-day repeated dose oral toxicity study with reproductive/developmental toxicity screening) with the NOAEL reported as 1000 mg/kg bw/day in both cases.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 a DNEL 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 registered substance is not acutely toxic via the oral route and investigation of an analogue substance via the dermal route gave the same conclusion (LD50 > 2000 mg/kg). Oral administration of an analogue test item to rats by gavage, at dose levels of 30, 100, 250 and 1000 mg/kg bw/day, was well tolerated in two subacute studies (28-day repeated dose oral toxicity and 28-day repeated dose oral toxicity study with reproductive/developmental toxicity screening) with the NOAEL reported as 1000 mg/kg bw/day in both cases. 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 a DNEL could not be derived.