Registration Dossier

Administrative data

Description of key information

The registration item was not acutely toxic to animals.

 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
4 250 mg/kg bw
Quality of whole database:
The available study is considered as reliable with some restrictions.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 mg/kg bw
Quality of whole database:
The available study is considered as reliable with some restrictions.

Additional information

The substance 3,5,5,-trimethylhexyl acetate was not acutely toxic to rats in a reliable and valid acute oral toxicity study and the oral LD50 value was 4250 mg/kg bodyweight. In addition, the substance was not acutely toxic in a reliable and valid acute dermal toxicity study in rabbits with a dermal LD50 value >5000 mg/kg body weight. Information about the acute inhalation toxicity of the substance is not available. However, dermal and oral routes of exposure are considered to be the most likely routes of human exposure to this fragrance substance. Overall, the registration item exhibits low acute toxicity.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on acute toxicity, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the eighth time in Regulation (EU) No 2016/918.