Registration Dossier

Administrative data

Description of key information

LD50 = 128.0 mg/kg-oral male rat
LD50 = 148.3 mg/kg-oral female rat
4h-LC50 = 0.034 mg/L-inhalation rat
Acute dermal data of this substance is scientifically waived due to low potential based on irritative but not corrosive property to skin, and low Kow (1.09) is not supposed to be absorbed through the skin.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
128 mg/kg bw

Acute toxicity: via inhalation route

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

Additional information

In relation to the dermal route of exposure, this substance is a skin irritant and there was an absence of systemic toxicity from oral studies by rat. so that acute toxicity study by dermal can be waived due to the strictly controlled conditions used by polymer manufacturers. So, this product is not classified by acute dermal toxicity on GHS.

In relation to the inhalation route of exposure, intristic hazadous properties determined from the experimental data (GHS Category 1) are significantly mitigated from a risk perspective as commercial product (substance) has practically no respirable fraction (all componens with a particle size of >355 um). So, this product (>355um) is not classified by acute inhalation toxicity on GHS .

Justification for classification or non-classification

Category 3 (oral) as LD50 is between 50 and 300 mg/kg bw (128 mg/kg bw)

Category 1 (inhalation) as LD50 is less than 0.05 mg/l (0.034 mg/l). This however is limited to micronized particle <10 um.

Acute toxicity-irreversible damage after single exposure: non-classification due to the irritative property and absence of systemic toxicity.