Registration Dossier

Administrative data

Description of key information

Test results for acute oral, dermal and inhalation toxicity are given below. At the concentrations used for these tests there were no fatalities in any of the tests and no abnormalities exhibited on necropsy. The actual values given in the test reports show that the values to be greater than the figures given here

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
200 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Exposure to large concentrations of this material in situations other than the manufacturing process is unlikely. It is generally included in formulations to control the viscosity of the end product and is normally only required at low concentrations (~ 1% or less). The most likely exposure in the work place is inhalation of dust during processing. This material has been manufactured and used commercially since the 1970’s. During more than thirty years of its manufacture and use in formulated products we are not aware of any issues relating to the health of operators who come into daily contact with this material. As a result of short-term testing, the material is not considered to be toxic by ingestion, inhalation or dermal contact, even at high dose levels. There were no effects at the maximum tested concentrations of 2000 mg/kg orally or dermally. A whole-body inhalation study performed at a loading of 200mg/l over 1 hour resulted in no adverse effects.

Comments from test results and observation may indicate

Eyes:  Direct contact may cause mild irritation as with any particulate matter

Skin:  No significant irritation or systemic effects from single short-term exposure

Inhalation:  May irritate the respiratory passage very slightly, but no evidence of adverse effects following exposure to dust or to sprayed aqueous mixtures during use

Oral: No adverse effects.

Justification for classification or non-classification

Results of acute toxicity testing indicate no classification is required.