Registration Dossier
Registration Dossier
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EC number: 617-143-5 | CAS number: 80675-49-6
Toxicological Summary
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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