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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Two acute oral (similar to OECD guideline 401) and one inhalation study (similar to OECD guideline 403) are available. No relevant clinical symptoms were noted. Mortality did not occur. The oral LD50 was determined in excess of 5000 mg/kg bw, the LC50 was > 5.15 mg/L.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating conc.
Value:
5 150 mg/m³ air

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute oral toxicity

The potential of acute oral toxicity of the test substance was investigated in a study with 5 male and 5 female Wistar rats. 10 mL/kg body weight of the test item were prepared in 0.5 % aqueous carboxymethyl cellulose suspension and applied via gavage in a concentration of 5000 mg/kg body weight. The observation period was 14 days. Clinical signs were investigated on the day of application and at least once a day thereafter. At the end of the observation period the animals were sacrificed. No mortality occured and no gross pathological findings were observed. Therefore, the LD50 of the test substance is > 5000 mg/kg body weight under the test conditions chosen here.

Acute inhalation toxicity

The potential of an inhalation hazard of the test substance was examined in an acute inhalation toxicity study in male and female Wistar rats. A head-nose inhalation system INA 20 with a volume of ca. 55 L was used during exposure. The substance was dispersed with Aerosil E 200 (5 % m/m) to ensure better flowability and the dust-aerosol was generated with a Vibratomat. A variable oscillation amplitude and slit were used to obtain different concentrations. A volumetric flow of 1500 L/h was used during the 4 -hour exposure of the animals. A 10 % overpressure in the exposure chamber ensured that the substance-air mixture was not diluted by external air. Determination of the concentration was done gravimetrically. Particle size determination was carried out using an Andersen Stack Sampler Mark III. 10 male and 10 female Wistar rats, ca. 8 weeks of age at the beginning of the study, were exposed to 5.15 mg/L of a dust-aerosol of the test substance. No mortality occured. Clinical symptoms during exposure included an increased breathing rate. Following exposure, the animals exhibited accelerated or intermittent breathing and scrubby fur. These symptoms had disappeared by day 6 following exposure. Gross pathology revealed slightly yellow lungs in the sacrificed animals. According to the results of this study, the LC50 following 4 -hour inhalation exposure to the test substance was > 5.15 mg/L for male and female Wistar rats.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. No mortality occured at the limit dose of 5000 mg/kg bw in an acute oral toxicity study and at 5.15 mg/m³ by inhalation. As a result, the substance is not considered to be classified for acute oral or inhalative toxicity under Regulation (EC) No. 1272/2008.