p-mentha-1,4(8)-diene

Endpoint summary

Description of key information

In an acute oral toxicity study (similar to OECD Guideline No 401) performed in rats, the LD50 was 3740 mg/kg bw.
In an acute dermal toxicity study (similar to OECD Guideline No 402) performed in rabbits, the LD50 was higher than 4300 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

3 740 mg/kg bw

Quality of whole database:

Study performed similarly to OECD guideline 401 with deviations but considered as appropriate and reliable to complete this endpoint.

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:

4 300 mg/kg bw

Quality of whole database:

Study performed similarly to OECD Guideline No 402 with deviations but considered as appropriate and reliable to complete this endpoint.

Additional information

In an acute oral toxicity study (similar to OECD 401 Guideline), 4 groups of 10 rats were given a single oral dose of terpinolene monoconstituent at 3.0, 3.5, 4.0 and 5.0 mL/kg bw. Animals were then observed for mortality and clinical signs of toxicity. No clinical signs were observed. Deaths occured at 3.5 mL/kg bw and above.

The oral LD₅₀ of terpinolene monoconstituent is 4.39 mL/kg bw in rats, corresponding to about 3740 mg/kg bw.

In an acute dermal toxicity study (similar to OECD 402 Guideline), four rabbits were administered a single dermal dose of terpinolene monoconstituent of 5 mL/kg bw. All animals were observed for mortality and clinical signs of toxicity. No mortality occurred at the tested dose level.

The acute dermal LD₅₀ of terpinolene monoconstituent was considered to be higher than 5 mL/kg bw, corresponding to 4300 mg/kg bw.

Justification for selection of acute toxicity – oral endpoint
Only one study available for this endpoint

Justification for selection of acute toxicity – inhalation endpoint
Acute toxicity is already assessed by two different routes of exposure (oral and dermal routes), that showed very low toxicity, with high LD50 values.
Therefore in accordance with column 2 of REACH Annex VIII (section 8.5), the acute toxicity by inhalation does not need to be conducted.

Justification for selection of acute toxicity – dermal endpoint
Only study available for this endpoint

Justification for classification or non-classification

Oral and dermal LD₅₀ are higher than 2000 mg/kg bw in rats and rabbits, respectively, therefore terpinolene monoconstituent is not classified for acute toxicity according to Directive 67/548/EEC and CLP Regulation (EC) No. 1272/2008.

However, based on its viscosity, terpinolene monoconstituent is classified for aspiration hazard Category 1 according to Regulation (EC) No. 1272/2008 (hydrocarbon with a kinematic viscosity of less than 20.5 mm2/s at 40°C) and as harmful "R65: may cause lung damage if swallowed" according to Directive 67/548/EEC.