Registration Dossier

Administrative data

Description of key information

GLP-studies according to OECD guidelines 423 and 402 are available for tripropylene glycol butyl ether highers (TPnB-H).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
300 mg/kg bw

Acute toxicity: via dermal route

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

Additional information

Oral: an acute oral toxicity test (Acute Toxic Class Method) was conducted with Fischer 344 rats to determine the potential for Dowanol™ TPnB-H Glycol Ether to produce toxicity from a single dose via the oral route. Under the conditions of this study, the acute oral LD50 of Dowanol™ TPnB-H Glycol Ether is estimated to be between 300 and 2,000 mg/kg of body weight in female rats.

Dermal: an acute dermal toxicity test was conducted with Fischer 344 rats to determine the potential for Dowanol TPnB-H Glycol Ether to produce toxicity from a single topical application. Under the conditions of this study, the single dose acute dermal LD50 of the test substance was greater than 2,000 mg/kg of body weight in male and female rats.

Inhalation: no study for acute inhalation toxicity has been conducted with TPnB-H as inhalation exposure is unlikely due to the low vapor pressure

(<0.01 mbar at 20°C).

Justification for classification or non-classification

Tripropylene glycol butyl ether highers (TPnB-H) should be classified as harmful via the oral route - according to EU criteria - based on an estimated oral LD50 between 300 and 2000 mg/kg bw in rats.

The dermal LD50 of TPnB-H is greater than 2000 mg/kg bw. Hence, no classification for acute dermal toxicity is required according to EU criteria.