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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
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:
- 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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- hexyl 2-methylprop-2-enoate
- EC Number:
- 205-521-9
- Cas Number:
- 142-09-6
- Molecular formula:
- C10H18O2
- IUPAC Name:
- hexyl 2-methylprop-2-enoate
- Test material form:
- liquid
- Details on test material:
- Commercial grade assumed (~98%)
Constituent 1
Test animals
- 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
Test system
- 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
Results and discussion
In vivo
Resultsopen allclose all
- 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
Any other information on results incl. tables
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.
Applicant's summary and conclusion
- 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.
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