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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
Endpoint summary
Administrative data
Description of key information
Skin irritation:
- in vivo (rabbit): slightly/moderately irritating
Eye irritation:
- WoE: not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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.
- 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
- 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 - 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) - 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
- 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).
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
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) |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 31-Aug-2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test was conducted according to OECD Test Guideline No. 437, 2009, under GLP Standards, and QA.
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline for Testing of Chemicals 437: Bovine Corneal Opacity and Permeability (BCOP) Test Method for Identifying Ocular Corrosives and Severe Irritants (September, 2009)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: not relevant: in vitro test
- Strain:
- other: Bovine
- Details on test animals or tissues and environmental conditions:
- BOVINE EYES:
- Source: Bovine eyes from young cattle were obtained from the slaughterhouse, where the eyes were excised by a slaughterhouse employee as soon as possible after slaughter. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 ul per cornea
NEGATIVE CONTROL
- Amount(s) applied (volume or weight with unit): 750 ul of physiological saline per cornea
POSITIVE CONTROL
- Amount(s) applied (volume or weight with unit): 750 ul per cornea
- Concentration (if solution): 10% (w/v) Benzalkonium Chloride - Duration of treatment / exposure:
- Exposure: 10 minutes
Post incubation period: 120 minutes - Observation period (in vivo):
- Not applicable
- Details on study design:
- TEST SITE: Isolated bovine cornea
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, 3 times
- Time after start of exposure: 10 minutes
SCORING SYSTEM:
- After the 10 minutes exposure and washing step, the corneas were incubated for 120 +/- 10 minutes at 32 °C. After the completion of the incubation period opacity determination was performed by sodium fluorecein treatment. Incubation 90 min. Optical density of the medium determined at 490 nm.
- The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro score:
In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).
TOOL USED TO ASSESS SCORE: opacitymeter and microplate reader.
DATA EVALUATION: A test substance that induces an IVIS ≥ 55.1 is defined as a corrosive or severe irritant. - Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean at 10 minutes
- Value:
- 4.3
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- No pH effect of the test substance was observed on the rinsing medium.
- Interpretation of results:
- other: not severe irritant or corrosive
- Remarks:
- based on CLP criteria
- Conclusions:
- In the in vitro Bovine Corneal Opacity and Permeability test, cornmint oil (mentha arvensis) did not induce ocular irritation through both endpoints, opacity and permeability, resulting in a mean in vitro irritancy score of 4.3 after 10 minutes of treatment. It is concluded that this test is valid and that Cornmint oil (mentha arvensis) is not severe irritant or corrosive in the BCOP test under the experimental conditions described in the report.
- Executive summary:
This in vitro study was performed according to OECD Guideline 437 (2009) to assess the corneal irritation and damage potential of Cornmint oil (mentha arvensis) by means of the Bovine Corneal Opacity and Permeability Assay (BCOP) using fresh isolated bovine corneae. The negative control responses of the opacity and permeability values were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (10% (w/v) Benzalkonium Chloride) was 119 and was within the historical positive control data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly. Cornmint oil (mentha arvensis) did not induce ocular irritation through both endpoints, opacity and permeability, resulting in a mean in vitro irritancy score of 4.3 after 10 minutes of treatment. Finally, it is concluded that this test is valid and that Cornmint oil (mentha arvensis) is not severe irritant or corrosive in the BCOP test under the experimental conditions described in the report.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1974
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Read across from peppermint oil. The documentation is a summary of methods and results, individual scores are not included.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- In an eye irritation test following the method of Draize, 0.1 ml of 10, 20, 30, 40, 50, or 60% test substance in olive oil was applied to the right eye (conjunctival sac) of rabbits (8 animals/dose group). The upper and lower lids were held closed for one minute. Afterwards, the eyes of 4 animals were rinsed for 1 minute with physiological saline and those of the remaining 4 were not rinsed. The test substance mixture was warmed at the 3 highest concentrations to keep the mixture fluid.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- No data on test animals and environmental conditions.
- Vehicle:
- other: Olive oil
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 10, 20, 30, 40, 50, and 60% - Duration of treatment / exposure:
- 1 minute and 24 hours
- Observation period (in vivo):
- 24 hours
- Number of animals or in vitro replicates:
- 48 (8/dose group)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): In each dose group the eyes of 4 animals were rinsed for 1 minute with physiological saline, and those of the remaining 4 were not rinsed.
- Time after start of exposure: 1 minute
SCORING SYSTEM: No data
TOOL USED TO ASSESS SCORE: No data - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- no effects observed in all concentrations, no individual scores provided
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- no effects observed in all concentrations, no individual scores provided
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- no effects observed in all concentrations, no individual scores provided
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- no effects observed in all concentrations, no individual scores provided
- Irritant / corrosive response data:
- At 10, 20, 30, 40, 50, or 60% no effects and no reactions were observed.
- Other effects:
- no other effects reported
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Based on CLP criteria
- Conclusions:
- At 10, 20, 30, 40, 50, and 60% no effects and no reactions were observed. Under the conditions of this study, 10 to 60% test substance in olive oil was not an eye irritant in rabbits.
- Executive summary:
In an eye irritation test following the method of Draize, 0.1 ml of 10, 20, 30, 40, 50, or 60% test substance, Brazilian menthol (peppermint oil), diluted in olive oil, was applied to the right eye (conjunctival sac) of rabbits (8 animals/dose group). The upper and lower lids were held closed for one minute. Afterwards, the eyes of 4 animals were rinsed for 1 minute with physiological saline and those of the remaining 4 were not rinsed. The test substance mixture was warmed at the 3 highest concentrations to keep the mixture fluid. At 10, 20, 30, 40, 50, or 60% no effects and no reactions were observed. Under the conditions of this study, 10 to 60% Brazilian menthol (peppermint oil) in olive oil was not an eye irritant in rabbits. The documentation is a summary of methods and results, individual scores are not included. Therefore, no conclusion on classification in accordance with 67/548/EEC and 1272/2008/EC can be drawn.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- The read across justification is presented in the document attached to this record.
- Reason / purpose for cross-reference:
- read-across source
- Number of animals or in vitro replicates:
- 48 (8/dose group)
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- no effects observed in all concentrations, no individual scores provided
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- no effects observed in all concentrations, no individual scores provided
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- no effects observed in all concentrations, no individual scores provided
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- no effects observed in all concentrations, no individual scores provided
- Irritant / corrosive response data:
- At 10, 20, 30, 40, 50, or 60% no effects and no reactions were observed.
- Other effects:
- no other effects reported
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- based on CLP criteria
- Conclusions:
- The eye irritant properties of cornmint oil were assessed using read across from the source substance peppermint oil. At 10, 20, 30, 40, 50, and 60% no effects and no reactions were observed. Under the conditions of this study, 10 to 60% test substance in olive oil was not an eye irritant in rabbits.
- Executive summary:
The eye irritant properties of cornmint oil were assessed using read across from the source substance peppermint oil. In an eye irritation test following the method of Draize, 0.1 ml of 10, 20, 30, 40, 50, or 60% test substance, Brazilian menthol (peppermint oil), diluted in olive oil, was applied to the right eye (conjunctival sac) of rabbits (8 animals/dose group). The upper and lower lids were held closed for one minute. Afterwards, the eyes of 4 animals were rinsed for 1 minute with physiological saline and those of the remaining 4 were not rinsed. The test substance mixture was warmed at the 3 highest concentrations to keep the mixture fluid. At 10, 20, 30, 40, 50, or 60% no effects and no reactions were observed. Under the conditions of this study, 10 to 60% Brazilian menthol (peppermint oil) in olive oil was not an eye irritant in rabbits. The documentation is a summary of methods and results, individual scores are not included. Therefore, no conclusion on classification in accordance with 67/548/EEC and 1272/2008/EC can be drawn.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The key study for skin irritation was performed with cornmint oil (Peppermint Flavour - Arvensis) and resulted in an overall irritation score of 3 indicating slight/moderate erythema and oedema at 24 hours. 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 could be concluded that cornmint oil does not have to be classified as irritating in accordance with 67/548/EEC or 1272/2008/EC.
As the study was not performed according to current guidelines with an irregular scoring system, and the major constituent L-menthol is classified as irritating to the skin and present at levels higher than the thresholds mentioned for classification and labeling (in both 68/548/EEC and 1272/2008/EC), the essential oils belonging to the mint category are considered to be irritating to the skin.
The conclusion on eye irritation was based on a Weight of Evidence approach. An in vitro BCOP test in accordance with OECD437 was performed with Cornmint oil. Results show a mean in vitro irritancy score (IVIS) of 4.3 indicating that the substance is not severe irritant or corrosive (A substance that induces an IVIS ≥ 55.1 is defined as a corrosive or severe irritant).
Additionally, an in vivo eye irritation test with category member peppermint oil was available and used for read across. In this test, peppermint oil was applied to the eyes (conjunctival sac) of eight rabbits per dose group following the method of Draize. Afterwards, the eyes of 4 animals were rinsed for 1 minute with physiological saline and those of the remaining 4 were not rinsed. At 10, 20, 30, 40, 50, or 60% no effects and no reactions were observed. Under the conditions of this study, 10 to 60% Brazilian menthol (peppermint oil) in olive oil was not an eye irritant in rabbits. The documentation is a summary of methods and results, individual scores are not included. Therefore, definite conclusions on classification in accordance with 67/548/EEC and 1272/2008/EC cannot be drawn based on the available study results for cornmint oil.
However, the major constituent L-menthol is classified for Eye Irritation Category 2 according to CLP (Regulation 1272/2008/EC). As this constituent is present at levels higher than the thresholds mentioned for classification and labelling in that Regulation, the essential oils belonging to the mint category can be considered to be irritating to the eye and should also be classified with Eye Irritation Category 2.
According to the Dangerous Substances Directive (67/548/EEC), L-menthol is not classified as an eye irritant and therefore classification of the essential oils belonging to the mint category as eye irritant is also not required.
Justification for selection of skin irritation / corrosion endpoint:
The selected study is the key study for the skin irritation endpoint.
Justification for selection of eye irritation endpoint:
No selection is made as a Weight of Evidence approach was followed which is described below.
Effects on skin irritation/corrosion: slightly irritating
Justification for classification or non-classification
Based on the key information for skin irritation/corrosion, the substance Cornmint oil needs to be classified as irritating to the skin in accordance with the CLP Regulation (1272/2008/EC) and Dangerous Substances Directive (67/548/EEC).
Based on the WoE information for eye irritation, the substance Cornmint oil needs to be classified as irritating to the eye in accordance with the CLP Regulation (1272/2008/EC) but under the Dangerous Substances Directive (67/548/EEC).
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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