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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.
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is performed according to an unspecified guideline unspecified, and provides acceptable basic data.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: no data on guideline available
- Deviations:
- not applicable
- Principles of method if other than guideline:
- The test substance was applied to the clipped dorsum of 8 rabbits for 4 hours under individual semi-occlusive patches. Reaction grades for erythema, oedema, cracking and scaling were assessed 4, 24, 48, and 72 hours after treatment by using grades ranging from "a"(very slight) to "h"(severe). An overall irritation score was assigned to each tested substance ranging from 0 (normal skin) to 7 (extreme).
- GLP compliance:
- no
Test material
- Reference substance name:
- cornmint oil
- IUPAC Name:
- cornmint oil
- Details on test material:
- - Name of test material (as cited in study report): Peppermint Flavour - Arvensis
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 9-12 weeks
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped 3-4 days before test start, animals in the telogen phase of hair growth were selected
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 0, 24, 48 and 72 hours after treatment, and occasionally up to 7 days after treatment.
- Number of animals:
- 8
- Details on study design:
- TEST SITE
- Area of exposure: dorsal surface
- Type of wrap if used: 2.5 cm2 of cotton gauze (8 ply folded in two) laid on a piece of thin flexible polythene (3 cm x 3 cm) attached to a piece of zinc oxide plaster (9 cm x 2.5 cm)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): treatment site wiped clean of excess material
- Time after start of exposure: upon patch removal (after 4 hrs)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.6
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1.4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1.4
- Max. score:
- 4
- Reversibility:
- no data
- Remarks:
- after 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1.6
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- no data
- Remarks:
- after 72 hours
- Irritant / corrosive response data:
- no other data
- Other effects:
- no data
Any other information on results incl. tables
Overall Irritation score for each animal
Animal number | 265 | 272 | 288 | 291 | 311 | 313 | 317 | 322 | Total irritation score per group |
Group | |||||||||
Diethyl Phtalate | 1 | 1 | 1 | - | 1 | 1 | 1 | 0 | 6 |
Geraniol | 3 | 3 | 3 | - | 2 | 4 | 4 | 3 | 22 |
Peppermint Flavour - Arvensis | 2 | 3 | 3 | - | 3 | 3 | 4 | 3 | 21 |
Distribution of overall irritation scores (0 -7) within each treatment group
Overall Irritation Scores | 0 | 1 | 2 | 3 | 4 | 5 | 6 | 7 |
Group | ||||||||
Diethyl Phtalate | 1 | 6 | ||||||
Geraniol | 1 | 4 | 2 | |||||
Peppermint Flavour - Arvensis | 1 | 5 | 1 |
In order to classify the test substance, the irritation scoring from "a" to "h" is converted to the grading of skin reactions as defined by OECD Guideline for the testing of chemicals No. 404: Acute Dermal Irritation/Corrosion.
The conversion for erythema:
Reaction Grades in this study | OECD grading of skin reactions |
a (marginal/very slight) | 1 (very slight) |
b (slight) | 1 (very slight) |
c (fairly distinct) | 2 (well defined) |
d (quite distinct) | 2 (well defined) |
e (becoming well developed) | 2 (well defined) |
f (well developed) | 3 (moderate to severe) |
g (becoming severe) | 3 (moderate to severe) |
h (severe) | 4 (severe) |
The conversion for oedema:
Reaction Grades in this study | OECD grading of skin reactions |
a (marginal/very slight) | 1 (very slight) |
b (slight) | 2 (slight) |
c (fairly distinct) | 2 (slight) |
d (quite distinct) | 2 (slight) |
e (becoming well developed) | 3 (moderate) |
f (well developed) | 3 (moderate) |
g (becoming severe) | 4 (severe) |
h (severe) | 4 (severe) |
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Remarks:
- Based on CLP criteria
- Conclusions:
- The overall Irritation Score for cornmint oil (Peppermint Flavour - Arvensis) was slightly irritating towards rabbits under the conditions of this test. After conversion of the used irritation scores to the grading of skin reactions as defined by OECD Guideline for the testing of chemicals No. 404: Acute Dermal Irritation/Corrosion, it was concluded that cornmint oil does not have to be classified as irritating in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
- Executive summary:
Cornmint oil (Peppermint Flavour - Arvensis), two control substances (Diethyl Phtalate and Geraniol), and Peppermint Flavour - Brazilian were applied to the clipped dorsum of 8 rabbits for 4 hours under individual semi-occlusive patches. Reaction grades for erythema, oedema, cracking and scaling were assessed 4, 24, 48, and 72 hours after treatment by using grades ranging from "a" (very slight) to "h" (severe). An overall irritation score was assigned to each tested substance ranging from 0 (normal skin) to 7 (extreme). The overall irritation score for Peppermint Flavour - Arvensis was 3 (Slight/moderate erythema and oedema at 24 hours. The reaction generally reduced to slight at 72 hours, but sometimes the slight/moderate reaction was maintained.
In order to classify Peppermint Flavour - Arvensis according to the current guidelines, the reaction grades wee converted to OECD grading of skin reactions. This resulted in an OECD grading for Peppermint Flavour - Arvensis of 1.5 for erythema (very slight - well defined) and 1.7 for oedema (very slight - slight). It is concluded that cornmint oil does not need to be classified as irritating to the skin based on the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
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