Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
Based on existing data on constituents (additivity principles), the registered substance has an oral ATE mixture estimated at 2687 mg/kg bw and should not be classified for acute oral toxicity hazard according to the rules for classification of mixtures of Regulation (EC) No 1272/2008.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- calculation (if not (Q)SAR)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- accepted calculation method
- Principles of method if other than guideline:
- Classification based on calculation rules for mixtures of the CLP Regulation
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 2 687 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on existing data on constituents (additivity principles), the registered substance has an oral ATE mixture estimated at 2687 mg/kg bw and should not be classified for acute oral toxicity hazard according to the rules for classification of mixtures of Regulation (EC) No 1272/2008.
- Executive summary:
The NCS is composed of several identified constituents and in that, it can be considered as a mixture according to the definition of the CLP Regulation.
The decision logic for classification of mixtures from the ECHA Guidance on the Application of the CLP Criteria (2017) was used to determine the acute oral toxicity hazard of the registered substance. An oral DL50 or an ATE estimate can be derived based on the current classification for a part of these constituents.Based on existing data on constituents (additivity principles), the ATE of the Essential oil of Litsea cubeba (Lauraceae) obtained from the fruits by distillation, terpenes fraction is the following:
Oral ATE(mix) = 2687 mg/kg bw
As the oral DL50/ATE of the substance is calculated to be higher than 2000 mg/kg bw, therefore, the Essential oil of Litsea cubeba (Lauraceae) obtained from the fruits by distillation, terpenes fraction is not classified for acute oral toxicity.
In conclusion, the decision not to classify the substance was taken on the basis of existing data on constituents (additivity principles): the registered substance has an oral ATE mixture estimated at 2687 mg/kg bw and should not be classified for acute oral toxicity hazard according to the rules for classification of mixtures of Regulation (EC) No 1272/2008.
Reference
The NCS is composed of several identified constituents and in that, it can be considered as a mixture according to the definition of the CLP Regulation.
The decision logic for classification of mixtures from the ECHA Guidance on the Application of the CLP Criteria (2017) was used to determine the acute oral toxicity hazard of the registered substance.
An oral DL50 or an ATE estimate can be derived based on the current classification for a part of these constituents.
Data on constituents:
Constituent | CAS# | Range | Typical concentration | Oral DL50/ ATE estimates | Sources |
l-limonene | 5989-54-8 | 45-60 | 51 | LD50 > 5000 mg/kg bw Not classified | https://echa.europa.eu/fr/registration-dossier/-/registered-dossier/10807/7/3/1 |
Eucalyptol | 470-82-6 | 1-10 | 5,50 | LD50 = 4500 mg/kg bw Not classified | https://echa.europa.eu/fr/registration-dossier/-/registered-dossier/13231/7/3/1 |
Beta-myrcene | 123-35-3 | 1-10 | 5,30 | LD50 > 5000 mg/kg bw Not classified | https://echa.europa.eu/fr/registration-dossier/-/registered-dossier/14795/7/3/1 |
(Z)-3,7-dimethylocta-2,6-denial | 106-26-3 | 1-10 | 5,00 | LD50 = 6800 mg/kg bw Not classified | https://echa.europa.eu/fr/registration-dossier/-/registered-dossier/6329/7/3/1 |
6-methylhept-5-en-2-one | 110-93-0 | 1-10 | 5,00 | LD50 = 3570 mg/kg bw Not classified | https://echa.europa.eu/fr/registration-dossier/-/registered-dossier/12205/7/3/1 |
(1S,5S)-2,6,6-trimethylbicyclo[3.1.1]hept-2-ene (alpha pinene) | 7785-26-4 | 1-10 | 5,00 | Oral LD50 cut-off value = 500 mg/kg Acute Tox. 4 | https://echa.europa.eu/fr/registration-dossier/-/registered-dossier/14528/7/3/1 |
Beta-pinene | 127-91-3 | 1-10 | 4,10 | Not classified | C&L Inventory: https://echa.europa.eu/fr/information-on-chemicals/cl-inventory-database/-/discli/details/36440 |
(R)-3,7-dimethyl-1,6-octadien-3-ol (l-linalool) | 126-91-0 | 1-10 | 3,00 | LD50 ≥ 2000 mg/kg bw Not classified | https://echa.europa.eu/fr/registration-dossier/-/registered-dossier/27524/7/3/2 |
Sabinen | 3387-41-5 | 1-10 | 2,80 | Oral LD50 cut-off value = 2000 mg/kg Acute Tox. 4 | https://echa.europa.eu/fr/registration-dossier/-/registered-dossier/26637/7/3/1 |
(R)-3,7-dimethyloct-6-enal (R-citronellal) | 2385-77-5 | 1-10 | 2,70 | LD50 = 2423 mg/kg bw Not classified | https://echa.europa.eu/fr/registration-dossier/-/registered-dossier/22664/7/3/1 |
Geranial | 141-27-5 | 0-5 | 2,50 | LD50 = 6800 mg/kg bw Not classified | https://echa.europa.eu/fr/registration-dossier/-/registered-dossier/17552/7/3/2 |
Camphene | 79-92-5 | 0-5 | 1,50 | LD50 > 2000 mg/kg bw Not classified | https://echa.europa.eu/fr/registration-dossier/-/registered-dossier/14290/7/3/1 |
Isogeranial | 72203-98-6 | 0-5 | 1,00 | LD50 = 3220 mg/kg bw Not classified | IFRA Labelling Manual 2019 |
Isoneral | 72203-97-5 | 0-1 | 0,40 | LD50 = 3220 mg/kg bw Not classified | IFRA Labelling Manual 2019 |
p-mentha-1,4(8)-diene | 586-62-9 | 0-1 | 0,30 | LD50 = 3740 mg/kg bw Not classified | https://echa.europa.eu/fr/registration-dossier/-/registered-dossier/10412/7/3/1 |
2,3-Dehydro 1,8-cineol | 92760-25-3 | 0-2 | 0,25 | No data | / |
Alpha phellandrene | 99-83-2 | 0-2 | 0,25 | Acute tox 4 or Not classified Precautionary approach: ATE = 500 | C&L Inventory: https://echa.europa.eu/fr/information-on-chemicals/cl-inventory-database/-/discli/details/22821 |
6-Methyl hept-5-en-2-ol | 1569-60-4 | 0-1 | 0,20 | Not classified | C&L Inventory : https://echa.europa.eu/fr/information-on-chemicals/cl-inventory-database/-/discli/details/84179 |
Gamma-terpinene | 99-85-4 | 0-1 | 0,20 | LD50 > 2000 mg/kg bw Not classified | https://echa.europa.eu/fr/registration-dossier/-/registered-dossier/26624/7/3/2 |
Minor constituents not contributing to the C&L | / | 0-10 | 0,75 | / | / |
For substances not classified or with an oral LD50 > 2000 mg/kg bw, an ATE estimates of 2001 has been considered according to the CLP Regulation.
For substances with an oral LD50 > 5000 mg/kg bw, an ATE estimates of 5001 has been considered according to the CLP Regulation.
See full study report on attached background material for detailled calculation.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 687 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 study available
Additional information
The NCS is composed of several identified constituents and in that, it can be considered as a mixture according to the definition of the CLP Regulation.
The decision logic for classification of mixtures from the ECHA Guidance on the Application of the CLP Criteria (2017) was used to determine the acute oral toxicity hazard of the registered substance. An oral DL50 or an ATE estimate can be derived based on the current classification for a part of these constituents.
Based on existing data on constituents (additivity principles), the ATE of the Essential oil of Litsea cubeba (Lauraceae) obtained from the fruits by distillation, terpenes fraction is the following:
Oral ATE(mix) = 2687 mg/kg bw
As the oral DL50/ATE of the substance is calculated to be higher than 2000 mg/kg bw, therefore, the Essential oil of Litsea cubeba (Lauraceae) obtained from the fruits by distillation, terpenes fraction is not classified for acute oral toxicity.
In conclusion, the decision not to classify the substance was taken on the basis of existing data on constituents (additivity principles): the registered substance has an oral ATE mixture estimated at 2687 mg/kg bw and should not be classified for acute oral toxicity hazard according to the rules for classification of mixtures of Regulation (EC) No 1272/2008.
Justification for classification or non-classification
Harmonized classification:
The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self classification:
Acute toxicity (Oral):
Based on existing data on constituents (additivity principles), the registered substance has an oral ATE mixture estimated at 2687 mg/kg bw and should not be classified for acute oral toxicity hazard according to the rules for classification of mixtures of Regulation (EC) No 1272/2008.
Acute toxicity (Dermal):
No information was available. Not required for substances at the REACH Annex VII tonnage level.
Acute toxicity (Inhalation):
No information was available. Not required for substances at the REACH Annex VII tonnage level.
Specific target organ toxicity: single exposure (Oral):
Based on the typical composition, the registered substance has no constituent classified for Specific target organ toxicity: single exposure (Oral) category 1 or category 2. Therefore, the substance should not be classified for Specific target organ toxicity: single exposure (Oral) according to the regulation (EC) No. 1272/2008 and to the GHS.
Specific target organ toxicity: single exposure (Dermal):
No information was available. Not required for substances at the REACH Annex VII tonnage level.
Specific target organ toxicity: single exposure (Inhalation):
No information was available. Not required for substances at the REACH Annex VII tonnage level.
Aspiration hazard:
The registered substance has more than 10% of its constituents classified as Aspiration hazard cat.1 but no data on the kinematic viscosity was available. Therefore, in a worst-case approach, and based on the typical composition, the substance should be classified for aspiration hazard category 1, H304 (May be fatal if swallowed and enters airways according to the regulation (EC) No. 1272/2008) according to CLP Regulation and GHS.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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