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EC number: 205-521-9 | CAS number: 142-09-6
- 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
n-hexyl methacrylate was tested with respect of its acute dermal irritant/corrosive properties following the patch test method. Method: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FDA Draize (1959) (Evonik Oil Additives GmbH, 1978)
In this study n-HMA is a slight to moderate skin irritant.
For the endpoint eye irritation no study with n-HMA was available. Therefore a read across using the category approach was used to predict the irritating properties of n-HMA.
n-HMA lies between BMA and 2-EHMA of the C1-C8 methacrylate esters. i-BMA and n-BMA are slightly irritating in the rabbit eye and 2-EHMA slightly to none irritating. Thus, it can be assumed that the eye irritating property of n-HMA lies also in-between as there are no further indicators for stronger irritation. For precautionary reasons n-HMA has to be regarded as slightly irritating in a worst case approach.
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:
- guideline study with acceptable restrictions
- Remarks:
- Test procedure in accordance with national standard methods with acceptable restrictions. Restrictions: Observation period only 72 h, only two observations, duration of treatment 24 h instead of 4h.
- Qualifier:
- according to guideline
- Guideline:
- other: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FDA Draize (1959)
- Principles of method if other than guideline:
- Information about the method, described in the study report ( Draize test: skin irritation/corrosion), is given in the free text field " Any other information materials and methods incl. tables".
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: mean value 2,5 kg
- Housing: individual housing
- Diet: ad libitum standard diet (Mümmel Z, Plange)
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C
- Humidity (%): 45 - 55 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and shaved/abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated skin areas of the test animals serve as the control (shaved, scarified).
- Amount / concentration applied:
- undiluted 0.5 mL (equal to 443 mg (density 0.886 g/cm3))
- Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- 24h and 72h post application
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100% the whole torso of the animal was covered with a gummed bandage
- Type of wrap if used: gummed bandage to wrap up the body of the test animal.
REMOVAL OF TEST SUBSTANCE
- Removal of the test substance by removal of the adhesive tape and the bandage, no wash off
SCORING SYSTEM:
Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Very severe erythema (beef redness) to eschar formation preventing grading of erythema: 4
Maximum possible: 4
Edema Formation
No edema: 0
Very slight edema (barely perceptible) : 1
Slight edema (edges of area well defined by definite raising):2
Moderate edema (raised approximately 1mm): 3
Severe edema (raised more than 1mm and extending beyond area of exposure):4
Maximum possible: 4 - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other:
- Remarks:
- 48 h value was not determined. No data in respect to reversibilty for times after exposure > 72h. Too short study duration to make a statement about reversibility. Only data of shaved skin have been used, data of shaved and scarified skin have not been used.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.92
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other:
- Remarks:
- 48 h value was not determined. No data in respect to reversibilty for times after exposure > 72h. Too short study duration to make a statement about reversibility. Only data of shaved skin have been used, data of shaved and scarified skin have not been used.
- Irritant / corrosive response data:
- Not reported
- Other effects:
- Not reported
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Classification: not irritating Criteria used for interpretation of results: EU
- Conclusions:
- n-Hexyl methacrylate was not irritating in a primary skin irritation study in rabbits (24-hour occlusive application, no wash of the
test substance). No data in respect to reversibilty for times after > 72h observation. Only data of shaved skin have been used, data of shaved and
scarified skin have not been used.
According to the results of this dermal irritation study n-Hexylmethacrylate has to be classified as follows:
According to EU-GHS (CLP): Hazard category: None (effects < 2.3 both erythem and oedema)
According to UN-GHS: Hazard category: 3 (Erythem > 1.5 but < 2.3, 24 hour application, no wash off the test substance) mildly irritating - Executive summary:
In a primary dermal irritation study New Zealand White rabbits were dermally exposed (intact and scarified skin) to
0.5 mL undiluted n-Hexyl methacrylate for 24 hours. Animals then were observed for 3 days. Irritation was scored by the method of Draize et al., 1959.
The mean erythema score (average value of the single scores (animals 1-6; erythema; intact skin, 24h and 72h) was determined to be 1.667 out of 4 and the mean oedema score was 1.9167 out of 4.
Remarks concerning the study result: The study for acute skin irritation/corrosion was performed before OECD 404 came into force. For this reason the test values were reevaluated according to OECD criteria and test scores (erythema, oedema) obtained for the scarified skin were regarded as irrelevant.
According to the results of this dermal irritation study n-Hexylmethacrylate has to be classified as follows:
According to GefStoffV: slightly below the irritancy threshold (non-irritant, but 24 hour application, no wash off the test substance)
According to EU-GHS (CLP): Hazard category: None (effects < 2.3 both erythem and oedema)
According to UN-GHS: Hazard category: 3 (Erythem > 1.5 but < 2.3, 24 hour application, no wash off the test substance) mildly irritating.
NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.
Reference
Overall primary irritation score (PDII): 3.6 of 8 scores FDA (Draize), 1959,
re-evaluated according to OECD 404
|
Remarks concerning the study result: The study for acute skin irritation/ corrosion was performed before OECD 404 came into force. For this reason the test values were reevaluated according to OECD criteria and test scores (erythema, oedema) obtained for the scarified skin were regarded as irrelevant. Classification criteria according to the different classification systems: EU-GHS: Category 1: Corrosive subcategories Corrosive in >= 1 of 3 animals (applies to authorities not using subcategories): Corrosive (only applies to some authorities) Subcategory Exposure Observation ------------------------------------------------------------ 1A <= 3 minutes <= 1 hour 1B > 3 minutes to <= 1 hour <= 14 days 1C > 1 hour to <= 4 hours <= 14 days ------------------------------------------------------------ A: Single harmonized corrosion category, using the results of animal testing. A: Corrosive is a test substance that produces destruction of skin tissue, namely, visible necrosis through the epidermis and into the dermis, in at least 1 of 3 tested animals after exposure up to 4 hours duration. Corrosive reactions are typified by ulcers, bleeding, bloody scrabs and, by the end of observation at 14 days, by discoloration due to bleaching of the skin, complete areas of alopecia and scars. Histopathologic determinations should be consided evaluate questionable lesions. Substances and/or mixtures are considered corrosive (Skin categorry 1) if it has a pH of 2 or less or a pH of 11.5 or greater. If consideration of alkali/acid reserve suggests the substance or prepatration may not be corrosive despite the low or high pH value, then further testing needs to be carried out to confirm this, preferably by use of an appropriate validated in vitro test. Category 2: (1) Mean value of >= 2.3 to < 4.0 for erythem/eschar or for oedema in at least 2 of 3 animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions, or (2) Inflammation that persits to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scalling, or (3) In some cases where there is pronounced variability of response amoung animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above. UN-GHS (additional category 3): Category 3: Mild irritant (Applies to only some authorities for e.g. UN-GHS) Mean value of >= 1.5 to < 2.3 for erythem/eschar or for oedema from gradings in at least 2 of 3 tested animals from grades at 24, 48 and 72 hours or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions (when not included in the irritant category above). According to the results of this dermal irritation study n-Hexylmethacrylate has to be classified as follows: According to EU-GHS (CLP): Hazard category: None (effects < 2.3 both erythem and oedema) According to UN-GHS: Hazard category: 3 (Erythem > 1.5 but < 2.3, 24 hour exposition, no wash off the test substance)ems:
Classification criteria according to the different classification systems:
Classification criteria according to the different classification systems:
Classification criteria according to the different classification systems:
EU-GHS:
Category 1: Corrosive subcategories
Corrosive in >= 1 of 3 animals
(applies to authorities not using subcategories): Corrosive
(only applies to some authorities)
Subcat. Exposure Observation
1A <= 3 minutes <= 1 hour
1B > 3 minutes -- <= 1 hour <= 14 days
1C > 1 hour -- <= 4 hours <= 14 days
A single harmonized corrosion category is provided in Table 3.2.1, using the results of animal
testing. A corrosive is a test material that produces destruction of skin tissue, namely, visible necrosis
through the epidermis and into the dermis, in at least 1 of 3 tested animals after exposure up to a 4 hour
duration. Corrosive reactions are typified by ulcers, bleeding, bloody scabs and, by the end of observation at
14 days, by discoloration due to blanching of the skin, complete areas of alopecia and scars. Histopathology
should be considered to discern questionable lesions.
A mixture is considered corrosive (Skin Category 1) if it has a pH of 2 or less or a pH of 11.5 or greater. If
consideration of alkali/acid reserve suggests the substance or preparation may not be corrosive despite the low or high pH value, then further testing needs to be carried out to confirm this, preferably by use of an appropriate validated in vitro test.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study. The test followed recognized toxicology testing procedures and recognized scoring procedures of the results.
- Justification for type of information:
- The C1-C8 methacrylate esters are slight to mild irritants except for 2-EHMA, which is practically non to slightly irritating.
n-HMA lies between BMA and 2-EHMA of the C1-C8 methacrylate esters. i-BMA and n-BMA are slightly irritating in the rabbit eye and 2-EHMA slightly to none irritating. Thus, it can be assumed that the eye irritating property of n-HMA lies also in-between as there are no further indicators for stronger irritation. For precautionary reasons n-HMA has to be regarded as slightly irritating in a worst case approach. - Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the safety of chemicals in foods, drugs and cosmetics", Division of Pharmacology, FDA (Draize) (1959)
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation:
- Weight at study initiation: 2.4-2.6 kg
- Housing: no data
- Diet (e.g. ad libitum): Mümmel Z, Plange
- Water (e.g. ad libitum): tap water
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18
- Humidity (%): 45-55
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- Not rinsed
- Observation period (in vivo):
- 24, 48 and 72 h, and 4, 5, 6 and 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Six New Zealand White rabbits had 0.1 ml of undiluted test material instilled into the conjunctival sac of the left eye. The right eye of each rabbit, which remained untreated, served as a control. Animals were observed for irritating effects of the cornea, iris, conjunctivae 24, 48 and 72 hours and 4, 5, 6 and 7 days after treatment.
SCORING SYSTEM: Draize scale - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Except for some initial redness, none of the animals showed any effects of the treatment.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Classification: not irritating Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008
- Conclusions:
- Classification: not irritating
- Executive summary:
The ocular irritation that could be induced by 2-ethylhexyl methacrylate was evaluated in the rabbit according to the recommendations of the "Appraisal of the safety of chemicals in foods, drugs and cosmetics", Division of Pharmacology, FDA (Draize) (1959). A single application of 0.1 ml of 2-ethylhexyl methacrylate in its original form was placed into the conjunctival sac of one eye of six New-Zealand white rabbits. The ocular reactions were observed at 24, 48 and 72 hours and up to 7 days after the instillation. Mean values (24+48+72 h) for ocular irritation were: 0.0 for chemosis, enanthema, congestion and opacity. Under these experimental conditions, 2-ethylhexyl methacrylate was considered as not irritating when administered to the rabbit by ocular route.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The C1-C8 methacrylate esters are slight to mild irritants except for 2-EHMA, which is practically non to slightly irritating.
n-HMA lies between BMA and 2-EHMA of the C1-C8 methacrylate esters. i-BMA and n-BMA are slightly irritating in the rabbit eye and 2-EHMA slightly to none irritating. Thus, it can be assumed that the eye irritating property of n-HMA lies also in-between as there are no further indicators for stronger irritation. For precautionary reasons n-HMA has to be regarded as slightly irritating in a worst case approach. - Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemall GmbH & Co. KG
- Age at study initiation: 8-10 W
- Weight at study initiation: no data
- Housing: individually
- Diet (e.g. ad libitum): mümmel z, ssniff/Soest
- Water (e.g. ad libitum): tap water
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 2
- Humidity (%): 40 - 50
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Amount applied: 0.1 ml
- Duration of treatment / exposure:
- The test eyes were not washed out following the instillation
- Observation period (in vivo):
- 1, 24, 48 and 72 hours as well as 8 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Observation time: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: Observation time: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: Observation time: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Observation time: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Observation time: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: Observation time: 8 days
- Irritant / corrosive response data:
- One hour after dosing, two animals exhibited slight conjunctival redness, chemosis and discharge, which persisted for 24 hours in one animal. The second animal also exhibited conjunctival redness at 24 hours after dosing. At 48 hours following dosing all signs of irritation had resolved. The remaining animal showed no signs of irritation at any time during the test.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- not classified Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008
- Conclusions:
- Classification: not irritating
- Executive summary:
In an OECD 405 guideline study, n-butyl methacrylate (0.1 ml) was placed in the conjunctival sac of the right eye of three New Zealand White rabbits. The lids were then gently held together for one second. The test eyes were not washed out following the instillation. The left eye remained untreated for control. The eyes were examined at 1, 24, 48 and 72 hours as well as 8 days from beginning of test. Eye irritation was scored for signs of corneal damage (density, area), iris reaction and lesions of the conjunctivae (erythema, chemosis, discharge). Additionally, the cornea was examined with the aid of fluorescein after recording the observations at 24 hours. One hour after dosing, two animals exhibited slight conjunctival redness, chemosis and discharge, which persisted for 24 hours in one animal. The second animal also exhibited conjunctival redness at 24 hours after dosing. At 48 hours following dosing all signs of irritation had resolved. The remaining animal showed no signs of irritation at any time during the test. n-Butyl methacrylate is considered as slightly irritating to eyes.
Referenceopen allclose all
Classification of eye irritation studies according GHS-criteria
Substance: n-Butyl methacrylate CAS: 97-88-1
Source: UNTER 88-022
Animal No. |
Corneal opacity/Hornhauttrübung[Scores]
|
Mean Draize score in 2 of 3 animals |
Reversibility [scores] |
Hazard category |
|||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
|
||
1 |
0 |
0 |
0 |
0 |
0 |
|
|
2 |
0 |
0 |
0 |
0 |
0 |
|
|
3 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
0 |
|
|
none |
|
|
|
|
|
|
|
|
Animal No. |
Iritis/Regenbogenhautentzündung[Scores]
|
Mean Draize score in 2 of 3 animals |
Reversibility [scores] |
Hazard category |
|||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
|
||
1 |
0 |
0 |
0 |
0 |
0 |
|
|
2 |
0 |
0 |
0 |
0 |
0 |
|
|
3 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
0 |
|
|
none |
|
|
|
|
|
|
|
|
Animal No. |
Conjunctiva redness (erythem) /Bindehautrötung[Scores]
|
Mean Draize score in 2 of 3 animals |
Reversibility [scores] |
Hazard category |
|||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
|
||
1 |
1 |
0 |
0 |
0.33 |
0 |
|
|
2 |
0 |
0 |
0 |
0 |
0 |
|
|
3 |
1 |
0 |
0 |
0.33 |
0 |
|
|
|
|
|
|
|
|
|
none |
Animal No. |
Conjunctiva chemosis /Bindehautödem[Scores]
|
Mean Draize score in 2 of 3 animals |
Reversibility [scores] |
Hazard category |
|||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
|
||
1 |
0 |
0 |
0 |
0 |
0 |
|
|
2 |
0 |
0 |
0 |
0 |
0 |
|
|
3 |
1 |
0 |
0 |
0.33 |
0 |
|
|
|
|
|
|
|
|
|
none |
Classification: Hazard Category |
none |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Eye irritation
It is considered, that n-butyl methacrylate in its function as source material for the read across possess the potential for maximum slight irritation effects on the rabbit eye, which were below the criteria for classification according to 67/548/EEC and CLP / UN-GHS criteria, respectively.
No classification.
Please note: While the data support no classification, the CLP Annex VI entries still specify n-BMA as well as n-HMA as eye irritant, category 2.
Justification for classification or non-classification
n-hexyl methacrylate was not irritating in a valid primary skin irritation study in rabbits (24-hour occlusive application, no wash of the test substance). No data in respect to reversibilty for times after > 72h observation. Only data of shaved skin have been used, data of shaved and scarified skin have not been used.
The mean erythema score (average value of the single scores (animals 1-6; erythema; intact skin, 24h and 72h) was determined to be 1.667 out of 4 and the mean oedema score was 1.9167 out of 4. (Evonik Oil Additives GmbH, 1978)
According to the results of this dermal irritation study n-Hexylmethacrylate has to be classified as follows:
According to EU-GHS (CLP): Hazard category: None (effects < 2.3 both erythem and oedema)
According to UN-GHS: Hazard category: 3 (Erythem > 1.5 but < 2.3, 24 hour application, no wash off the test substance) mildly irritating
In an OECD 405 guideline study, n-butyl methacrylate (0.1 ml) was placed in the conjunctival sac of the right eye of three New Zealand White rabbits (Schreiber and Wodtke, 1988). The lids were then gently held together for one second. The test eyes were not washed out following the instillation. The left eye remained untreated for control. The eyes were examined at 1, 24, 48 and 72 hours as well as 8 days from beginning of test. Eye irritation was scored for signs of corneal damage (density, area), iris reaction and lesions of the conjunctivae (erythema, chemosis, discharge). Additionally, the cornea was examined with the aid of fluorescein after recording the observations at 24 hours. One hour after dosing, two animals exhibited slight conjunctival redness, chemosis and discharge, which persisted for 24 hours in one animal. The second animal also exhibited conjunctival redness at 24 hours after dosing. At 48 hours following dosing all signs of irritation had resolved. The remaining animal showed no signs of irritation at any time during the test. n-Butyl methacrylate is considered as slightly irritating to eyes.
In summary, n-BMA causes only light irritation and is rated as non-irritant.
n-HMA lies between BMA and 2-EHMA of the C1-C8 methacrylate esters. The irritating potential is derived from both esters and is therefore regarded as non irritating.
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