Registration Dossier

Administrative data

Description of key information

Acute oral toxicity to female rats > 2000 mg/kg bw.. 
Acute dermal toxicity to rats > 2000 mg/kg bw..

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 dermal route

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

Additional information

Acute oral toxicity

Oxooil LS9 was tested in an acute oral toxicity study, performed according to OECD Guideline 420. Oxooil LS9 was administered as supplied by oral gavage to five female CD rats at a dosage of 2000 mg/kg bodyweight (limit test). Systemic signs of reaction to treatment were recorded during a subsequent 14-day observation period. There were no deaths and no signs of reaction to treatment. The acute oral median lethal dose (LD50) of the test material in the female CD rat is estimated to be greater than 2000 mg/kg bodyweight.

Acute dermal toxicity

Oxooil LS9 was tested in an acute dermal toxicity study, performed according to OECD Guideline 402. The test substance was administered to the clipped dorsal skin of 5 male and 5 female rats at a dosage of 2000 mg/kg bodyweight under occlusive dressings for 24 hours (Limit test). Systemic and local signs of reaction to treatment were recorded at least once daily for 14 days following removal of the dressings.  There were no deaths and no systemic signs of reaction to treatment. Very slight or well-defined erythema, from Day 1 to 8, desquamation (exfoliation), from Day 5 to 9, and scabbing from Day 4 to 14, were observed amongst four male and four females rats. The acute dermal median lethal dosage (LD50) to rats of Oxooil LS9 was demonstrated to be greater than 2000 mg/kg bodyweight.

 

Acute inhalation toxicity

Oxooil LS9 has been tested by both the oral and dermal routes of exposure and shown to be of low acute toxicity (LD50 > 2000 mg/kg bw.). Although absorption would be expected via the lung, repeated dose toxicity information indicates that it is unlikely to be any greater than by the oral route. Taking into account Annex XIII Section 8.5 of the REACH regulation, the use of vertebrate animals to study a third route of acute exposure is considered to be unjustified.

Justification for classification or non-classification

No classification for acute toxicity is indicated according to the general classification and labelling requirements for dangerous substances and preparations (Directive 67-548-EEC) or the classification, labelling and packaging (CLP) regulation (EC) No 1272/2008.