Registration Dossier

Administrative data

Description of key information

Oral: OECD425; rat LD50 >5000 mg/kg.  Reliability = 1
Dermal: OECD 402; rat LD50 >5000 mg/kg. Reliability = 1
Inhalation: OECD 403; rat 4-hr LC50 >5.2 mg/L (equivalent to >6.188 mg/L test substance corrected for molecular weight difference between test and read across substance). Reliability =2

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
6 188 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Additional information

The test substance has low oral and dermal toxicity in the rat. The rat oral and dermal LD50’s were >5000 mg/kg body weight. No data were available for acute inhalation toxicity with the test substance, but a 4-hour inhalation LC50 study in rats with 6:2 FTOH was used as a read across to fulfill the data gap for the test substance. The underlying hypothesis for the read-across between the test substance and 6:2 FTOH is that the test substance is transformed metabolically to 6:2 FTOH. The available in vitro data show that this transformation occurs extremely rapidly (half-life less than 3 minutes). While no actual in vivo rate data are available (aside from one study that demonstrates disappearance of the test substance), the transformation is still expected to occur rapidly. Therefore, it is reasonable to read-across the information from the acute inhalation study on 6:2 FTOH to address the data gap for the test substance. Based upon Probit analysis of the data, the rat 4-hour inhalation LC50 for 6:2 FTOH is >5.2 mg/L (equivalent to >6.188 mg/L test substance corrected for molecular weight difference between test and read across substance). 


Justification for selection of acute toxicity – oral endpoint
OECD guideline, GLP study

Justification for selection of acute toxicity – inhalation endpoint
LC50 is based on read across to acute inhalation study with 6:2 FTOH (OECD guideline, GLP study), which corrected for molecular weight differences between the test and read across substances, would yield an equivalent test substance 4-hour LC50 of >6.188 but <11.781 mgL.

Justification for selection of acute toxicity – dermal endpoint
OECD guideline, GLP study

Justification for classification or non-classification

Based on the acute oral LD50 in rats of >5000 mg/kg, the dermal LD50 in rats of >5000 mg/kg, and the inhalation 4-hour LC50 in rats with 6:2 FTOH of >5.2 mg/L (equivalent to >6.188 mg/L test substance when corrected for molecular weight difference between test and read across substance), no classification is required for acute oral, dermal, or inhalation endpoints according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 (ATP02).