Registration Dossier

Administrative data

Description of key information

Acute oral and dermal toxicity studies with analogue chemicals indicating minimal toxicological effects.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
3 600 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
5 000 mg/kg bw

Additional information

Oral Studies

In a key study, the acute oral LD50 value for the analogue chemical, dimyrcetol, was determined to be 4.1 g/kg bwt (3.5 to 4.8 g/kg bwt). In a second key study, the acute oral LD50 value for the analogue chemical, myrcenol, dihydro derivative, was 3.6 g/kg bwt (3.0 to 4.2 g/kg bwt). Signs of toxicity described included lethargy, piloerection, blood on the nose, flaccidity, ataxia, and diarrhea.

Dermal Study:

In a key study conducted for the Research Institute for Fragrance Materials, the acute dermal LD50 of dimyrcetol was determined to be > 5.0 g/kg bwt in rabbits. In a second key study, the acute dermal LD50 of myrcenol, dihydro derivative, was also determined to be > 5.0 g/kg bwt in rabbits. In these studies, there were 2/10 deaths recorded with clinical signs including moderate to severe erythema and mild to severe edema.

Inhalation Toxicity:

This requirement is waived based on the low vapor pressure of dihydromyrcenol, which precludes significant exposure by this route.

Please refer to Section 13 of this IUCLID file for read-across documentation and rationale for the selection of representative analogue chemicals.

Justification for classification or non-classification

Acute oral toxicity

Based on the acute toxicity of the analogue chemicals, dimyrcetol or myrcenol, dihydro derivative, dihydromyrcenol would not be rated for acute oral toxicity under either the EU DSD classification criteria (EU Directive 67/548/EEC) or under the EU CLP classification criteria (EU Regulation 1272/2008). Given the presence of apparent CNS depression in acute animal studies, dihydromyrcenol would be classified under the EU CLP classification criteria as STOT (single exposure) Category 3. Under the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN-GHS), dihydromyrcenol would be rated as Acute Toxicity, Category 5.

Inhalation toxicity

No information available for classification.

Dermal toxicity

 

Based on the results of acute dermal toxicity studies conducted in rabbits with the analogue chemicals, dimyrcetol or myrcenol, dihydro derivative, dihydromyrcenol would not be classified under the EU DSD classification criteria (EU Directive 67/548/EEC). Similarly, it would not receive classification under the EU CLP classification criteria (EU Regulation 1272/2008) or under the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN-GHS).