Registration Dossier

Administrative data

Description of key information

Acute oral toxicity
The acute median lethal oral dose (LD50) to rats of the test material was found to be > 5.0 g/kg bodyweight.
Acute inhalation
Testing by the inhalation route in accordance with column 2 of Annex VIII of 1907/2006/EC, is considered to be inappropriate as exposure of humans via inhalation is unlikely taking into account the vapour pressure of the substance (0.94 Pa at 20°C) and/or the possibility of exposure to aerosols or droplets of an inhalable size.
Acute dermal toxicity
One acute dermal study with limited detail is available that suggests LD50(dermal)>5000mg/kg bw). This is supported by an acute oral toxicity study that suggests the substance is not acutely harmful (LD50>5000mg/kg). Potential for systemic exposure via ingestion is considered to be higher than exposure following contact with skin, therefore the existing data from exposure via contact with skin is considerd to be reliable and represents the worse case.

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 study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
One acute dermal study with limited detail is available that suggests LD50(dermal)>5000mg/kg bw).

Additional information

Justification for selection of acute toxicity – oral endpoint
The acute median lethal oral dose (LD50) to rats of the test material was found to be > 5.0 g/kg bodyweight.

Justification for selection of acute toxicity – inhalation endpoint
The oral and dermal LD50 levels for the substance have been determined and both demonstrate relatively harmless levels of acute toxicity >2000 mg/kg bw and therefore do not require labelling under CLP. Testing by the inhalation route in accordance with column 2 of Annex VIII of 1907/2006/EC, is therefore considered to be inappropriate as exposure of humans via inhalation is unlikely taking into account the vapour pressure of the substance (0.94 Pa at 20°C) and/or the possibility of exposure to aerosols or droplets of an inhalable size.

Justification for selection of acute toxicity – dermal endpoint
One acute dermal study with limited detail is available that suggests LD50(dermal)>5000mg/kg bw).
Systemic exposure to Patchouli, ext. via contact with skin is unlikley to be more significant than exposure orally. Hence, the weight of evidence from the acute oral toxicity data (LD50 greater than 5 g/kg bw) where systemic exposure to Patchouli oil is considered to be higher than dermal exposure plus the limited acute dermal study represents a worse case assessment and the substance is considered not be acutely harmful in contact with skin. Classification and labelling is therefore not required.

Justification for classification or non-classification

The acute median lethal oral dose (LD50) to rats of the test material was found to be > 5.0 g/kg bodyweight, which is the maximum concentration for classification according to Regulation (EC) No 1272/2008.

One acute dermal study with limited detail is available that suggests LD50(dermal)>5000mg/kg bw). Systemic exposure to Patchouli, ext. via contact with skin is unlikely to be more significant than exposure orally. Hence, the weight of evidence from the acute oral toxicity data (LD50 greater than 5 g/kg bw) where systemic exposure to Patchouli oil is considered to be higher than dermal exposure plus the limited acute dermal study represents a worse case assessment and the substance is considered not be acutely harmful in contact with skin. Classification and labelling is therefore not required.