Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 202-715-5 | CAS number: 98-94-2
- 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
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- Nanomaterial pour density
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- 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
Several studies are available for both skin and eye irritation. The test species used was the rabbit.
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:
- weight of evidence
- Study period:
- 6th June 1977 to 11thNovember 1977
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Not compliant with guidelines or GLP. Skin was abraded prior to application of the test substance.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test substance was applied to rabbits to determine its potential skin irritancy.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Not documented
- Age at study initiation: Not documented
- Weight at study initiation: 2.33 - 2.55kg
- Housing: Not documented
- Diet (e.g. ad libitum): Not documented
- Water (e.g. ad libitum): Not documented
- Acclimation period: Not documented
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not documented
- Humidity (%): Not documented
- Air changes (per hr): Not documented
- Photoperiod (hrs dark / hrs light): Not documented
IN-LIFE DATES: From: 10 November 1977 To: 11 November 1977 - Type of coverage:
- not specified
- Preparation of test site:
- other: Intact and abraded shaved skin
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml - Duration of treatment / exposure:
- No information provided
- Observation period:
- 30 days post application. Readings were made at 4, 24, 48 and 72 hours post application.
- Number of animals:
- 6 animals
- Details on study design:
- No information provided
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 4 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: For both intact and abraded skin.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: For both intact and abraded skin.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: For both intact and abraded skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: For both intact and abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 4 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- no data
- Remarks on result:
- other: For both intact and abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- no data
- Remarks on result:
- other: For both intact and abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- no data
- Remarks on result:
- other: For both intact and abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- no data
- Remarks on result:
- other: For both intact and abraded skin
- Irritation parameter:
- other: Corrosion Score
- Basis:
- mean
- Time point:
- other: 4 hours
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- no data
- Remarks on result:
- other: For both intact and abraded skin
- Irritation parameter:
- other: Corrosion Score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: For both intact and abraded skin
- Irritation parameter:
- other: Corrosion Score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: For both intact and abraded skin
- Irritation parameter:
- other: Corrosion Score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: For both intact and abraded skin
- Irritant / corrosive response data:
- Following exposure to rabbits, the test substance was considered to be extremely irritating to the skin of the rabbits.
- Other effects:
- No additional information
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- Under the conditions of this study, the test substance, DMCHA, should be considered to be irritating, based on the results observed following exposure to rabbits. Based on these results, the test substance should be classified as a Category 1B skin corrosion/irritant and have the signal word Warning and the hazard statement H314: Causes severe skin burns and eye damage associated with it, in accordance with Regulation EC No. 1272/2008. According to Directive 67/548/EEC, the test substance should be classified as Corrosive (C) and should have the risk phrase R34 : Causes burns, associated with it.
- Executive summary:
In a study conducted by Katz (1977), the test substance, cyclohexyldimethylamine (DMCHA), was tested for its ability to cause irritation when applied to the skin of 6 rabbits. The skin of the test animals was either intact or abraded and 50ml of test substance was applied to each rabbit. Readings on erythema, oedema and corrosion score were made at 4, 24, 48 and 72 hours post application and observations continued for 30 days post application. Under the conditions of this study, the test substance, DMCHA, should be considered to be irritating, based on the results observed following exposure to rabbits. Based on these results, the test substance should be classified as a Category 1B skin corrosion/irritant and have the signal word Warning and the hazard statement H314: Causes severe skin burns and eye damage
associated with it, in accordance with Regulation EC No. 1272/2008. According to Directive 67/548/EEC, the test substance should be classified as Corrosive (C) and should have the risk phrase R34 : Causes burns, associated with it.- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Not documented
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Insufficient information to determine reliability
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- BASF internal test procedure
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- No information provided
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 -20% solution - Duration of treatment / exposure:
- Not documented
- Observation period:
- 8 days.
- Number of animals:
- Not documented
- Details on study design:
- TEST SITE
- Area of exposure: Backs and ears
- % coverage: Not documented
- Type of wrap if used: Not documented
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No information provided
- Time after start of exposure: Not relevant
SCORING SYSTEM: No information - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Reversibility:
- no data
- Remarks on result:
- other: light erythema was observed
- Irritation parameter:
- other:
- Basis:
- mean
- Time point:
- other: 8 days
- Reversibility:
- no data
- Remarks on result:
- other: Necrosis was observed
- Irritant / corrosive response data:
- Following 24 hours, light erythema was observed. After 8 days observations, necrosis was observed.
- Other effects:
- No information provided
- Interpretation of results:
- Category 1C (corrosive) based on GHS criteria
- Conclusions:
- Under the conditions of this study, the test material was considered to be corrosive. Based on these results, the test substance should be classified as Category 1C skin corrosive/irritant and should have the signal word signal word Warning and the hazard statement H314: Causes severe skin burns and eye damage associated with it, in accordance with Regulation EC No. 1272/2008. According to Directive 67/548/EEC, the test substance should be classified as Corrosive (C) and should have the risk phrase R34 : Causes burns, associated with it.
- Executive summary:
In a study conducted by BASF in 1960, the test substance cyclohexyldimethylamine (DMCHA) was applied to the backs and ears of rabbits to determine its potential skin irritancy. The test substance was applied undiluted and observations were made at 1, 5, 15 and 20 hours, with recordings made after 24 hours and 8 days. Following 24 hours, light erythema was observed. After 8 days observations, necrosis was observed. Under the conditions of this study, the test material was considered to be corrosive. Based on these results, the test substance should be classified as Category 1C skin corrosive/irritant and should have the signal word signal word Warning and the hazard statement H314: Causes severe skin burns and eye damage associated with it, in accordance with Regulation EC No. 1272/2008. According to Directive 67/548/EEC, the test substance should be classified as Corrosive (C) and should have the risk phrase R34 : Causes burns, associated with it.
Referenceopen allclose all
No additional information provided
Corrosive
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1960
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The age of this study means it was not conducted according to OECD or GLP guidelines. However, the brief method outlined indicates it conformed to guidelines available at the time.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test susbtance was applied to the eyes of rabbits and observations were made after 1 and 24 hours and 8 days.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- No information provided
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution): 5 -20% Solution - Duration of treatment / exposure:
- 8 days
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- Not specified
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not documented
- Time after start of exposure: Not documented
SCORING SYSTEM: Not documented
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein Not documented - Irritant / corrosive response data:
- Etching of the conjunctiva was observed at all time points examined, in addition to a milky opacity of the cornea. After 8 days, etching of the haw was observed, in addition to scarring and the corneal effects.
- Other effects:
- No other effects observed
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Under the conditions of this experiment, the test substance should be considered to be corrosive. According to Regulation EC No. 1272/20008, the test substance should be classified as Eye Dam 1 and should have the hazard phrase H318: "Causes serious eye damage" and the signal word Danger associated with it. According to Directive 67/548/5EEC, the test substance should be classified as R41 Risk of serious damage to eyes and have the symbol Xi and Danger associated with it.
- Executive summary:
In a study conducted by BASF in 1960, the test substance, cyclohexyldimethylamine (DMCHA), was applied to the eyes of rabbits to determine its potential as an eye irritant. The test substance was applied undiluted as a 5 -20% solution. Following application, the eyes were observed after 1 and 24 hours and then again after 8 days. Etching of the conjunctiva was observed 1 and 24 hours with etching of the haw observed after 8 days. Effects were also observed on corneal opacity. Under the conditions of this experiment, the test substance should be considered to be corrosive. According to Regulation EC No. 1272/20008, the test substance should be classified as Eye Dam 1 and should have the hazard phrase H318: "Causes serious eye damage" and the signal word Danger associated with it. According to Directive 67/548/5EEC, the test substance should be classified as R41 Risk of serious damage to eyes and have the symbol Xi and Danger associated with it.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 6th June 1977 to 11th November 1977
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Study is not OECD or GLP compliant. Insufficient information to determine reliability.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test substance was applied to the eyes of rabbits to determine its irritancy potential.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Not documented
- Age at study initiation: Not documented
- Weight at study initiation: 2.33 to 2.51kg
- Housing: Not documented
- Diet (e.g. ad libitum): Not documented
- Water (e.g. ad libitum): Not documented
- Acclimation period: Not documented
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not documented
- Humidity (%): Not documented
- Air changes (per hr): Not documented
- Photoperiod (hrs dark / hrs light): Not documented
IN-LIFE DATES: From: To: Not documented - Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.10ml - Duration of treatment / exposure:
- Test 1: 5 minute exposure
Test 2: 24 hour exposure - Observation period (in vivo):
- Test 1: 48 hour observations
Test 2: 72 hours observation
In both test, the animals reactions were observed for 30 days post application. - Number of animals or in vitro replicates:
- 8 test animals
- Details on study design:
- No information provided.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 5 minutes
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not specified
- Remarks on result:
- other: Following 5 minutes exposure
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Following 5 minutes exposure
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Following 5 minutes exposure
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 5 minutes
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not specified
- Remarks on result:
- other: Following 5 minutes exposure
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Following 5 minutes exposure
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 48 hour
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Following 5 minutes exposure
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 5 minutes
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Following 5 minutes exposure
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Following 5 minutes exposure
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Following 5 minutes exposure
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Following 24 hour exposure
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Following 24 hour exposure
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Following 24 hour exposure
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 hour
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Following 24 hour exposure
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Following 24 hour exposure
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Following 24 hour exposure
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Following 24 hour exposure
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Following 24 hour exposure
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Following 24 hour exposure
- Irritant / corrosive response data:
- Following application to the rabbits eyes, there were severely irritating effects seen following the 24 hour exposure period on the corneas, iris and conjunctivae with no improvement/reduction in effects observed at subsequent observation timepoints.
Following the 5 minute exposure, readings made at the 24 hour time-point indicated severe irritancy efects with no reduction at the 48 hour observation time-point. - Other effects:
- Upon application of the test substance to the rabbit eyes, the rabbits were in considerable stress, with screaming and hyperactivity recorded.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study, the test substance, DMCHA should be considered to be corrosive to the eye. Based on these results, the test substance should be classified as a Category 1 eye irritant with the signal word Danger and the hazard statement H318: Causes serious eye damage associated with, in accordance with Regulation EC No. 1272/2008. According to Directive 67/548/EEC, the test substance should be classified as an Irritant (Xi) and have the risk phrase R41 Risk of serious damage to eyes associated with it.
- Executive summary:
In a study conducted by Katz (1977), the test substance, cyclohexyldimethylamine (DMCHA), was applied to the eye of 8 rabbits to determine its ability to cause irritancy. The test substance was applied at a concentration of 0.10 ml for 5 minutes exposure (Test 1) and a 24 hour exposure (Test 2) in two separate tests. Observations were made at 5 minutes, 24 hours and 48 hours in Test 1 and at 24 hours, 48 hours and 72 hours in Test 2. Observations continued for 30 days post application. Upon application of the test substance to the rabbit eyes, the rabbits were in considerable stress, with screaming and hyperactivity recorded. Following application to the rabbits eyes, there were severely irritating effects seen following the 24 hour exposure period on the corneas, iris and conjunctivae with no improvement/reduction in effects observed at subsequent observation timepoints. Following the 5 minute exposure, readings made at the 24 hour time-point indicated severe irritancy efects with no reduction at the 48 hour observation time-point. Under the conditions of the study, the test substance, DMCHA should be considered to be corrosive to the eye. Based on these results, the test substance should be classified as a Category 1 eye irritant with the signal word Danger and the hazard statement H318: Causes serious eye damage associated with, in accordance with Regulation EC No. 1272/2008. According to Directive 67/548/EEC, the test substance should be classified as an Irritant (Xi) and have the risk phrase R41 Risk of serious damage to eyes associated with it.
Referenceopen allclose all
No additional information provided.
No additional information provided
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
On consideration of all the information presented, it is possible to conclude that the test substance in question, cyclohexyldimethylamine (DMCHA), is corrosive to the skin and a severe eye irritant. While the studies were not fully compliant with the relevant current guidelines, they were conducted sufficiently well, according to Guidelines extant at the time of the study. In addition, as all the studies presented had the same findings, it can be assumed that classification of 'Corrosive' is appropriate.
Skin Irritation:
In a study conducted by Katz (1977), the test substance, cyclohexyldimethylamine (DMCHA), was tested for its ability to cause irritation when applied to the skin of 6 rabbits. The skin of the test animals was either intact or abraded and 50ml of test substance was applied to each rabbit. Readings on erythema, oedema and corrosion score were made at 4, 24, 48 and 72 hours post application and observations continued for 30 days post application. Under the conditions of this study, the test substance, DMCHA, should be considered to be irritating, based on the results observed following exposure to rabbits. Based on these results, the substance should be classified as a Category 1B skin corrosion and have the signal word "Warning" and the hazard statement H314: Causes severe skin burns and eye damage associated with it, in accordance with
Regulation EC No. 1272/2008. According to Directive 67/548/EEC, the test substance should be classified as an Corrosive (C) and should have the risk phrase R34 : Causes burns, associated with it.
Eye Irritation:
In a study conducted by Katz (1977), the test substance, cyclohexyldimethylamine (DMCHA), was applied to the eye of 8 rabbits to determine its ability to cause irritancy. The test substance was applied at a concentration of 0.10 ml for 5 minutes exposure (Test 1) and a 24 hour exposure (Test 2) in two separate tests. Observations were made at 5 minutes, 24 hours and 48 hours in Test 1 and at 24 hours, 48 hours and 72 hours in Test 2. Observations continued for 30 days post application. Upon application of the test substance to the rabbit eyes, the rabbits were in considerable stress, with screaming and hyperactivity recorded. Following application to the rabbits' eyes, there were severely irritating effects seen following the 24 hour exposure period on the corneas, iris and conjunctivae with no improvement/reduction in effects observed at subsequent observation timepoints. Following the 5 minute exposure, readings made at the 24 hour time-point indicated severe irritancy effects with no reduction at the 48 hour observation time-point. Under the conditions of the study, the test substance, DMCHA should be considered to be a severe eye irritant. Based on these results, the test substance should be classified as a Category 1 eye irritant with the signal word Danger and the hazard statement H318: Causes serious eye damage associated with, in accordance with Regulation EC No. 1272/2008. According to Directive 67/548/EEC, the test substance should be classified as an Irritant (Xi) and have the risk phrase R41 Risk of serious damage to eyes associated with it.
Effects on skin irritation/corrosion: corrosive
Effects on eye irritation: corrosive
Justification for classification or non-classification
Skin Irritation/Corrosion:
On the basis of the results in the studies conducted, the test substance should be classified as Skin Corrosion/irritation 1B and have the hazard statement H314: Causes severe skin burns and eye damage associated with it, in accordance with Regulation EC No. 1272/2008. According to Directive 67/548/EEC, the test substance should be classified as R34 Causes burns and have the symbol C and the word Corrosive associated with it.
Eye Irritation/Corrosion:
On the basis of the results in the studies conducted, the test substance should be classified as Eye Dam 1 and have the hazard statement H318: Causes serious eye damage associated with it, in accordance with Regulation EC No. 1272/2008.
According to Directive 67/548/5EEC, the test substance should be classified as R41 Risk of serious damage to eyes and have the symbol Xi and Irritant associated with it.
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