Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

For assessing occupational risk in humans exposure to the skin and to dust or liquid aerosol is of relevance. Especially, the risk of skin sensitization after dermal exposure has to be assessed, due to the sensitizing properties of the substance shown in an LLNA (Leidenfrost, 2011).

No DNELs were delineated for dermal or inhalative exposure, because the tonnage specific requirement (1-10 t/y) does not stipulate a repeated dose toxicity study, which is the most relevant type of study for obtaining a DNEL, provided that a NOAEL can be set. The available database of the substance show, that its acute toxicity is low (oral LD50 > 5000 mg/kg) and that no irritant property for the substance is concluded (based on in vitro testing). Thus, the leading health effect, which has to be evaluated for risk assessment is the potential of skin sensitization. There are currently no available methods to determine thresholds and DNELs for skin sensitizers, therefore a quantitative risk assessment for this endpoint is not possible. In addition, no clear dose-response relationship could be delineated from the available LLNA. Instead, a qualitative risk assessment is proposed. According to potency categorization (ECHA guidance, Chapter R.8, Table R.8 -23, 2010) the substance is classified as at least a strong skin sensitizer. (No exact EC value could be obtained, but it was assumed that in any case the EC value is below 2 %). Substances with strong or even extreme potential for skin sensitization have to be allocated to the high hazard category (ECHA guidance, Part E, 2008).

Overall, the health risks depicted above are addressed appropriately with the safety measures outlined in chapter “Guidance on Safe Use” and by that workers are sufficiently protected from health risks.

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

The substance is not used in the public domain and direct exposure of consumers is thus not to be expected. Exposure of man via the environment is negligible and indirect exposure of consumers is thus not to be expected. Therefore no DNELs for the general population were derived.