Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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

A repeated dose (28 -day) feed study according to OECD TG 407 revealed for the substance a human relevant NOAEL at the highest concentration tested of 2500 ppm (approx. 212 mg/kg bw). The low toxicity of the substance was confirmed in a reproductive screening study according to OECD TG 421, where no effects on general toxicity, fertility or developmental toxicity were observed up to the highest concentration tested of 2500 ppm.

It is important to note that 2500 ppm was the highest dietary concentration that was practical to test, as higher levels were precluded due to the decreased food consumption considered to reflect the palatability of the dietary formulations (documented in the 14-day range finder study NR32HS). Testing by oral gavage administration was technically not possible, since a previous range finder study with doses from 500 up to 1000 mg/kg bw revealed that the substance led to mortality due to substance retention in the rat stomach (a yellow compacted mass was found at necropsy). As a consequence, the oral LD50 was predicted based on the repeated dose feed study and according to Bulgheroni et al. (Regulatory Toxicology and Pharmacology 53, 16 -19, 2009; see chapter Acute Toxicity for more information) to be > 2000 mg/kg bw.

The substance furthermore exhibits no irritant/corrosive, skin sensitizing or genotoxic potential.

Overall, based on the available data no human relevant systemic effects were seen and also no local effects. Therefore, no hazard is identified for workers and the appropriate hazard assessment conclusion is chosen. The hazard conclusion is valid for repeated and for acute exposure to the substance.

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

A repeated dose (28 -day) feed study according to OECD TG 407 revealed for the substance a human relevant NOAEL at the highest concentration tested of 2500 ppm (approx. 212 mg/kg bw). The low toxicity of the substance was confirmed in a reproductive screening study according to OECD TG 421, where no effects on general toxicity, fertility or developmental toxicity were observed up to the highest concentration tested of 2500 ppm.

It is important to note that 2500 ppm was the highest dietary concentration that was practical to test, as higher levels were precluded due to the decreased food consumption considered to reflect the palatability of the dietary formulations (documented in the 14-day range finder study NR32HS). Testing by oral gavage administration was technically not possible, since a previous range finder study with doses from 500 up to 1000 mg/kg bw revealed that the substance led to mortality due to substance retention in the rat stomach (a yellow compacted mass was found at necropsy). As a consequence, the oral LD50 was predicted based on the repeated dose feed study and according to Bulgheroni et al. (Regulatory Toxicology and Pharmacology 53, 16 -19, 2009; see chapter Acute Toxicity for more information) to be > 2000 mg/kg bw.

The substance furthermore exhibits no irritant/corrosive, skin sensitizing or genotoxic potential.

Overall, based on the available data no human relevant systemic effects were seen and also no local effects. Therefore, no hazard is identified for the general population and the appropriate hazard assessment conclusion is chosen. The hazard conclusion is valid for repeated and for acute exposure to the substance.