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:
other toxicological threshold
Value:
3 mg/m³
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

For the substance, a 28 day feeding study in rats is available. The NOAEL was set to >1026 mg/kg bw/d for females (lowest value, males were > 1160 mg/kg bw/d).

Since no adverse effects were observed at or above the limit dose of 1000 mg/kg bw, derivation of a DNEL for systemic toxicity is not needed.

However, the substance can be considered as an inert nuisance dust; therefore a value of 3 mg/m³ (inhalable fraction) is assumed instead to protect against long-term local effects.

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
Explanation for the modification of the dose descriptor starting point:

The test substance is not classified and labeled for acute systemic toxicity, according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

For the substance, a 28 day feeding study in rats was available. The NOAEL was set to > 1026 mg/kg bw/d for females (lowest possible value, males were > 1160 mg/kg bw/d).

It is noted that in the absence of effects at the limit dose, a DNEL is not needed.

For theoretical derivation of the oral DNEL, an assessment factor (AF) of 200 (interspecies: allometric scaling = 4; remaining differences = 2.5; intraspecies = 10; exposure duration =1 (in the absence of effects, the duration is not a significant descriptor as absent effects will not get worse with time); dose-response = 1; AF = 4 x 2.5 x 10 x 2 x 1 x 1 = 200) would be calculated. Consequently, a oral long-term systemic DNEL would be equal or higher than 5 mg/kg bw/d for the consumer.