Registration Dossier
Registration Dossier
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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.
Endpoint summary
Administrative data
Description of key information
Acute toxicity oral (rat): LD50: 1240 mg/kg bw (no guideline followed)
Acute toxicity dermal (rabbit): LD50 > 5000 mg/kg bw (no guideline followed)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Test according to unspecified guideline. Very concise reporting: chemical identity of test substance, origin, strain, sex, housing conditions, and health status of animals, testing conditions, and non lethal effects not reported. However, report is acceptable as basic data.
- Qualifier:
- according to guideline
- Guideline:
- other: no data on guideline available
- Deviations:
- not applicable
- Principles of method if other than guideline:
- Standard acute method, no details available.
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- no data
- Doses:
- 0.5, 1.2, 1.6 and 5 g/kg body weight
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- no data
- Statistics:
- no data
- Preliminary study:
- no applicable
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 1.24 other: g/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: within 24 hours
- Mortality:
- 0.5 g/kg - 1/10
1.2 g/kg - 5/10
1.6 g/kg - 6/10
5 g/kg - 10/10 - Clinical signs:
- other: no data
- Gross pathology:
- no data
- Other findings:
- no data
- Interpretation of results:
- other: Acute Tox. 4
- Remarks:
- Based on CLP criteria
- Conclusions:
- The acute oral toxicity (LD50) of Cornmint oil towards rats is 1.24 g/kg bw under the conditions of this test. Based on this result the substance should be classified as Acute Tox. 4 in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
- Executive summary:
The acute toxicity (LD50) of Cornmint oil towards rats was investigated according to a standard acute method (unspecified guideline). Rats were exposed to a single oral dose of 0.5, 1.2, 1.6 and 5 g/kg bw and were observed for 14 days. Per dose 10 rats were used. The acute toxicity (LD50) was found to be 1.24 g/kg bw under the conditions of this test.
Reference
Distribution of Mortality
| Observation Day | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 |
| Mortality | 3 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 240 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test according to unspecified guideline. Very concise reporting: Species, strain, source and sex of animals, environmental conditions, and time of dosing not reported. However, report is acceptable as basic data.
- Qualifier:
- according to guideline
- Guideline:
- other: no data on guideline available
- Deviations:
- not applicable
- Principles of method if other than guideline:
- standard acute method, no details available.
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Details on dermal exposure:
- no data
- Duration of exposure:
- no data
- Doses:
- 5 g/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- no data
- Statistics:
- no data
- Preliminary study:
- not applicable
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 other: g/kg bw
- Based on:
- test mat.
- Mortality:
- 0/10
- Clinical signs:
- other: no data
- Gross pathology:
- no data
- Other findings:
- no data
- Interpretation of results:
- not classified
- Remarks:
- Based on CLP criteria
- Conclusions:
- The acute dermal toxicity (LD50) of Cornmint oil towards rabbits is > 5 g/kg bw under the conditions of this test. Based on these results the substance Cornmint oil does not need to be classified as acute toxic based on the criteria outlined in Annex I of 1272/2008/EC.
- Executive summary:
The acute dermal toxicity (LD50) of Cornmint oil towards rabbits was investigated according to a standard acute method (unspecified guideline). Rats were exposed to a single oral dose of 5 g/kg bw and were observed for 14 days. Per dose 10 rats were used. The acute toxicity (LD50) was found to be > 5 g/kg bw under the conditions of this test.
Reference
Distribution of Mortality
| Observation Day | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 |
| Mortality | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Additional information
For both oral and dermal acute toxicity, standard acute tests were available; both conducted with Cornmint oil. The oral study indicated a LD50 of 1.24 g/kg bw and the dermal study indicated a LD50 > 5 g/kg bw. These values are used for classification as key descriptor values for oral and dermal exposure. There were no supporting studies available.
Justification for classification or non-classification
Based on the key information for oral acute toxicity, the substance Cornmint oil needs to be classified as Acute tox 4, harmful if swallowed when taking into account the criteria outlined in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC. Based on the key information for dermal acute toxicity, the substance Cornmint oil does not need to be classified as acute toxic based on the criteria outlined in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC.
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