Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 290-058-5 | CAS number: 90063-97-1 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Mentha arvensis, Labiatae.
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- no data available: testing technically not feasible
Marine water
- Hazard assessment conclusion:
- no data available: testing technically not feasible
STP
- Hazard assessment conclusion:
- no data available: testing technically not feasible
Sediment (freshwater)
- Hazard assessment conclusion:
- no data available: testing technically not feasible
Sediment (marine water)
- Hazard assessment conclusion:
- no data available: testing technically not feasible
Hazard for air
Air
- Hazard assessment conclusion:
- no hazard identified
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- no data available: testing technically not feasible
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- no potential to cause toxic effects if accumulated (in higher organisms) via the food chain
Additional information
Cornmint oil is a Natural Complex Substance, a mixture consisting of slightly soluble to soluble constituents. The toxicity of the NCS on algae, Daphnia and fish was not experimentally established. For these endpoints the toxicity was estimated by QSARs in Episuite EcoWin v1.00, in accordance with Appendix 7 of the EFEO NCS protocol. A statement on the NCS Protocol has been attached.
The 96h-LC50 of Cornmint oil towards fish was calculated to be 3.01 mg/l. The 48h-EC50 towards Daphnia magna was estimated at 2.43 mg/l. The estimated 96h-EC50 of Cornmint oil towards algae is 2.63 mg/l.
All constituents have the same working mechanisms (Narcosis and Polar narcosis) and there are no minor constituents that are toxic to the environment. A DPD+ analysis identified the following constituents to represent the dominant risks to the environment (see table). The ratio calculated from the constituent concentration and concentration limit is called Lead Substance Indicator (LSI).
|
|
|
Aquatic |
||
CAS |
Substance |
Conc. in corn mint (%) |
R-phrase(s) |
Conc. limit |
LSI |
5989 -54 -8 |
L-Limonene |
5.0 |
R50/53 |
0.25 |
20 |
89-48-5 |
Menthyl Acetate |
3.5 |
R51/53 |
2.5 |
1.4 |
Since the LSI of Menthyl acetate is less than 10 times compared to the LSI of L-Limonene, L-Limonene is considered as the lead constituent representative for the other constituents. Therefore, the exposure assessment is carried out using L-limonene and the PNECs for L-limonene are used for the risk assessment for the environment. These PNEC values were obtained from the disseminated REACH registration dossier for this substance (CAS number 5989 -54 -8) available on the ECHA website.
(1) A statement on the use of the protocol for Registration of Natural Complex Substance (NCS) under REACH as well as the protocol itself have been attached to the dossier.
Conclusion on classification
Classification
As is mentioned in the substance chapter 1.2, Cornmint oil dementholized is the typical quality in the dossier for Cornmint oil. This is the quality on which the calculation for the data requirements on toxicity towards Daphnia, algae and fish (EC50/LC50 values calculated from EPIWIN data on the constituents) is based. Based on the calculated EC50/LC50 values between 1 and 10 mg/L and the observed log Kow values of the constituents, Cornmint oil dementholized would need to be classified with Aquatic Chronic 2. Also for the other two qualities, Cornmint oil crude and Cornmint oil dementholized, low terpenes content, the environmental classification would be Aquatic Chronic 2 (details not provided in the dossier).
However, the classification for the environment is not based on the calculated EC50/LC50 values, but on the classifications of the constituents, which is in line with the CLP guidance. In order to determine the classification, the NCS is treated as a mixture. In the CLP guidance (2013) it is mentioned that classification is to be based on 1) available test data on the substance/mixture as a whole, and, if not available 2) test data available on similar mixtures and individual hazardous ingredients (so-called bridging) and, if not available 3) the classifications of the individual ingredients/constituents, combined with their concentrations in the mixture. For Cornmint oil, no test data is available for the substance as a whole and a similar substance/mixture for which test data is available is also not known. Therefore, the classification for the environment of all qualities of Cornmint oil is based on the classifications of the constituents together with their typical percentages in the UVCB substance.
The classifications for the constituents of the three qualities of Cornmint oil are provided in the below table. The information available in the IFRA/ IOFI labelling manual (IFRA/IOFI GHS working group 2013) was used as a basis. For constituents for which a disseminated REACH registration was already available, the IFRA information was checked and adjusted where necessary.
Constituent |
CAS number |
Cornmint oil dementholized % (typical) |
Cornmint oil dementholized, low terpenes content % (typical) |
Cornmint oil crude % (typical) |
Environmental classification (DSD) |
Environmental classification (CLP) |
L-Menthol |
2216-51-5 |
38.0 |
46.0 |
71.0 |
Not classified for environment (also in disseminated registration dossier) |
Not classified for environment (aquatic acute 3 acc to GHS) (also in disseminated registration dossier) |
Menthone |
89-80-5 |
24.0 |
21.5 |
8.5 |
R52/53 |
Aquatic chronic 3 |
Iso-Menthone |
491-07-6 |
9.0 |
9.0 |
3.8 |
R52/53 |
Aquatic chronic 3 |
L-Limonene |
5989 -54 -8
(limonene 138-86-3) |
5 |
0.5 |
3.4 |
R50/53 (also in disseminated registration dossier) |
Aquatic acute 1, chronic 1, with M-factor of 1 (also in disseminated registration dossier) |
Neo-Menthol |
2216-52-6 |
5.5 |
5.5 |
1.9 |
Analogue to Menthol: not classified for the environment |
Not classified for environment (aquatic acute 3 acc to GHS) |
Menthyl Acetate |
89-48-5 2623-23-6 |
3.5 |
4.0 |
2.5 |
R51/53 (also in dessiminated registration dossier) |
Aquatic chronic 2 (also in dessiminated registration dossier) |
Pulegone |
89-82-7 |
2.0 |
2.5 |
1.4 |
Not classified for environment |
Not classified for environment |
Iso-pulegol |
89-79-2 |
2.0 |
1.8 |
0.9 |
Not classified for environment (also in dessiminated registration dossier) |
Not classified for environment (also in dessiminated registration dossier) |
alpha-Pinene |
80-56-8 |
2 |
0.5 |
1 |
Not classified for environment (also in dessiminated registration dossier) |
Not classified for environment (also in dessiminated registration dossier) |
beta-pinene |
127-91-3 |
1.5 |
0.5 |
1 |
Not classified for environment (also in dessiminated registration dossier) |
Not classified for environment (also in dessiminated registration dossier) |
Piperitone |
89-81-6 |
1.0 |
1.5 |
0.2 |
Not classified for environment |
Not classified for environment (aquatic acute 3 acc to GHS) |
Octan-3-ol |
589-98-0 |
1.2 |
0.2 |
0.3 |
No data for Octan-3-ol For 1-octanol: Not classified for environment (also in disseminated registration dossier) |
No data for Octan-3-ol For 1-octanol: Not classified for environment (Aquatic acute 2 acc to GHS) (also in disseminated registration dossier) |
Neo-iso menthol |
491-02-1 |
0.8 |
0.8 |
0.3 |
Analogue to Menthol: not classified for the environment (also in disseminated registration dossier) |
Not classified for environment (aquatic acute 3 acc to GHS) (also in disseminated registration dossier) |
Neo-iso pulegol |
21290-09-5 29141-10-4 |
0.7 |
1.0 |
0.3 |
Analogue to Iso-pulegol: not classified for the environment |
Analogue to Iso-pulegol: not classified for the environment |
Germacrene D |
37839-63-7 |
0.5 |
1.5 |
0.5 |
No data |
No data |
1,8-cineole |
470-82-6 |
0.5 |
0.1 |
0.2 |
Not classified for environment (also in dessiminated registration dossier) |
Not classified for environment (also in dessiminated registration dossier) |
beta-Myrcene |
123-35-3 |
0.6 |
|
0.7 |
Not classified for environment (according to disseminated registration. dossier) |
Not classified for environment (according to disseminated registration dossier) |
Sabinene |
3387-41-5 |
0.4 |
|
0.3 |
No data |
No data |
beta-caryophyllene |
87-44-5
|
0.6 |
0.8 |
0.3 |
Not classified for environment |
Not classified for environment |
Unknown constituents |
|
1.2 |
2.3 |
1.5 |
|
|
Total |
|
100% |
100% |
100% |
|
|
Based on the data in the table, the following calculations are made for the three qualities of cornmint oil (typical):
Cornmint oil dementholized:
DPD:
The hazard ratios for Cornmint oil dementholized (see DPD Annex III, part A) are as follows:
HRR50/53= 5 / 25 = 0.2 This is <1 therefore R50/53 not applicable
HRR51/53= 5 / 2.5 + 3.5 / 25 = 2.14 This is >1 therefore R51/53 is applicable
CLP:
Calculation for aquatic hazard categories (see CLP table 4.1.1 and 4.1.2):
Aquatic acute category 1: 5 % * 1 = 5 %. This is <25%, therefore Aquatic acute 1 not applicable
Aquatic chronic category 1: 5 % * 1 = 5 %. This is <25%, therefore Aquatic chronic 1 not applicable
Aquatic chronic category 2: 5 % * 1 * 10 + 3.5% * 1 = 53.5%. This is >25%, therefore Aquatic chronic 2 isapplicable
Cornmint oil dementholized is therefore classified with R51/53 according to DSD and DPD, and Aquatic chronic category 2 according to CLP.
Please note: Cornmint oil dementholized (typical) contains 1.2% of known and unknown components with unknown hazards to the aquatic environment.
Cornmint oil dementholized, low terpenes content
DPD:
The hazard ratios for Cornmint oil dementholized, low terpenes content (see DPD Annex III, part A) are as follows:
HRR50/53= 0.5 / 25 = 0.02 This is <1 therefore R50/53 not applicable
HRR51/53= 0.5 / 2.5 + 4.0 / 25 = 0.36 This is <1 therefore R51/53 not applicable
HRR52/53= 0.5 / 0.25 + 4.0 / 2.5 + (21.5 + 9) / 25 = 4.82 This is >1 therefore R52/53 is applicable
CLP:
Calculation for aquatic hazard categories (see CLP table 4.1.1 and 4.1.2):
Aquatic acute category 1: 0.5 % * 1 = 0.5 %. This is <25%, therefore Aquatic acute 1 not applicable
Aquatic chronic category 1: 0.5 % * 1 = 0.5 %. This is <25%, therefore Aquatic chronic 1 not applicable
Aquatic chronic category 2: 0.5 % * 1 * 10 + 4% * 1 = 9%. This is <25%, therefore Aquatic chronic 2 not applicable
Aquatic chronic category 3: 0.5 % * 1 * 10 * 10 + 4%* 1 * 10 + (21.5 + 9)% * 1 = 120.5%. This is >25%, therefore Aquatic chronic 3 is applicable
The quality Cornmint oil dementholized, low terpenes content is therefore classified with R52/53 according to DSD and DPD, and Aquatic chronic category 3 according to CLP.
Please note: Cornmint oil dementholized, low terpenes content (typical) contains 3.8% of known and unknown components with unknown hazards to the aquatic environment
Cornmint oil crude
DPD:
The hazard ratios for Cornmint oil crude (see DPD Annex III, part A) are as follows:
HRR50/53= 3.4 / 25 = 0.136 This is <1 therefore R50/53 not applicable
HRR51/53= 3.4 / 2.5 + 2.5 / 25 = 1.46 This is >1 therefore R51/53 is applicable
CLP:
Calculation for aquatic hazard categories (see CLP table 4.1.1 and 4.1.2):
Aquatic acute category 1: 3.4 % * 1 = 3.4 %. This is <25%, therefore Aquatic acute 1 not applicable
Aquatic chronic category 1: 3.4 % * 1 = 3.4 %. This is <25%, therefore Aquatic chronic 1 not applicable
Aquatic chronic category 2: 3.4 % * 1 * 10 + 2.5% * 1 = 36.5%. This is >25%, therefore Aquatic chronic 2 is applicable
Cornmint oil crude is therefore classified with R51/53 according to DSD and DPD, and Aquatic chronic category 2 according to CLP.
Please note: Cornmint oil crude (typical) contains 2.3% of known and unknown components with unknown hazards to the aquatic environment
As can be seen above, the environmental classification based on the calculation rules in CLP is Aquatic Chronic 2 for Cornmint oil dementholized and Cornmint oil crude. For these two oils, the environmental classification is therefore the same using both methods (calculated EC50/LC50 values and calculation rules in CLP combined with classifications of the constituents). For Cornmint oil dementholized, low terpenes content the classification based on CLP calculation rules is Aquatic Chronic 3. For this last substance, there is therefore a discrepancy between the environmental classification based on the calculated EC50/LC50 and the environmental classification based on the calculation rules in CLP and the classifications of the constituents. However, preference is given to the official method as described by the CLP guidance for mixtures.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
