Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
Explanation for the modification of the dose descriptor starting point:

Tetrahydromyrcenol fulfils the REACH Annex VII to Annex XI information requirements in accordance with R 7.5-7.7 for assessing long-term systemic toxicity and it can be concluded that the substance does not have to be classified and labelled for the long-term effects and no adverse effects are observed at limit dose level for repeated dose, toxicity. A DNEL derivation is therefore not needed (Practical guide 14, section 5.2.1), the endpoint conclusion “no hazards identified” can be selected in the IUCLID overall endpoint summary of section 7 and no risk characterization is required for this endpoint category (Practical guide 14, 6.2).

Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
Explanation for the modification of the dose descriptor starting point:

Information on acute inhalation toxicity is not needed because acute toxicity via oral and dermal route is available (REACH Annex VII to Annex XI and in accordance with ECHA guidance Chapter R.7.4). Acute inhalation toxicity information has been derived based on route-to-route extrapolation from an acute oral toxicity study, which leads to the conclusion that classification and labeling is not needed for acute systemic inhalation (IUCLID section 7.2.2). In ECHA guidance R.8, Appendix R. 8-8 (2nd paragraph) a statement is made that a DNEL for acute toxicity should be derived if an acute toxicity hazard (leading to C&L) has been identified (November, 2012). This statement can be interpreted that if such classification is not needed DNEL derivation is not needed. In addition, in accordance with Practical guide 14, the endpoint conclusion “no hazards identified” can be selected in the IUCLID overall endpoint summary of section 7. Therefore no risk characterisation is required for this endpoint category (Practical guide 14, 6.2).

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population