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EC number: 241-045-8 | CAS number: 16969-10-1
- 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
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- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
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- 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
Irritating potential of 2 -Hydroxy-3 -phenoxy acrylate was evaluated by in vitro tests.
Negative results were obtained for skin irritation in the vitro study (OECD 439, with a mean cell viability of 79%) and in the in vivo study (OECD 404).
However, the substance is severely irritating when administered into the eyes of rabbits.
Based on these results, 2 -Hydroxy-3 -phenoxy acrylate is considered to be not irritating for skin, but severely irritating to the eyes.
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:
- supporting study
- Study period:
- June 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- not GLP
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach/Main, FRG
- Age at study initiation: not specified
- Weight at study initiation: 2.89 - 3.03 kg
- Housing: individually
- Diet (e.g. ad libitum): about 130 g per day per animal
- Water (e.g. ad libitum): about 250 ml per day per animal
- Acclimation period: at least 8 days bafore the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): air-conditionned without details
- Photoperiod (hrs dark / hrs light): 12/12
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Remarks:
- at least 15 hours before the beginning of the study
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin sites of the same animal
- Amount / concentration applied:
- Application of 0.5 ml of the undiluted test substance to the patch test (2.5 x 2.5)
- Duration of treatment / exposure:
- 4h
- Observation period:
- 72h
- Number of animals:
- 1 male and 2 females
- Details on study design:
- Application site : upper third of the back or flanks
Removal of the test substance at the end of exposure period with lutrol and lutrom/water (1:1)
Readings 30-60 minutes after removal of the test patches and 24, 48, 72 hours after the beginning of application. - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 3 intact animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 3 intact animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- There is no indication of skin irritation (no erythema and no edema) at 24 hr after exposure.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on this study on rabbits, the test item is considered to be not irritating to the skin.
- Executive summary:
The objective of this study was to evaluate the potential corrosive and irritant properties of the test item following dermal application on rabbits.
The test item was applied for 4 hours to a three rabbits with intact skin. No unscheduled deaths occurred during the study and no clinical signs were noted in any animals.
The body weight of the animals was unaffected by the test item treatment. After a 4-hour exposure (three animals), no erythema or edema were observed at 24 hours after exposure.
Based on this study on rabbits, the test item is considered to be not irritating to the skin.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 April 2015 - 05 June 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.46 (In vitro dermal irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 439 (In vitro dermal irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: reconstructed human epidermis
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- EpiskinTM Model Kit (0.38 cm2 tissues) supplied by SkinEthic Laboratories, Lyon, France.
Medium and Incubation T°C: 37°C
REMOVAL OF TEST SUBSTANCE
- Rinsing: At the end of the treatment period, each tissue was removed from the well of the treatment plate, and rinsed with D-PBS. Rinsing was achieved by gently filling and emptying several times each tissue with D PBS to gently remove any residual test or control items. The rinsed tissues were transferred to the second column of 3 wells containing 2 mL of maintenance medium in each well and the plates were incubated at +37°C, 5% CO2 in a humidified incubator for 42 hours.
POSITIVE CONTROL
Name: Sodium Dodecyl Sulphate (SDS) at a 5% (w/v) aqueous solution.
NEGATIVE CONTROL
Name: Dulbecco’s Phosphate-Buffered Saline (D-PBS).
SCORING SYSTEM:
- Optical density (OD) was measured at 570 nm:
Relative mean viability (%) = 100 x mean cOD(test item) / mean cOD(negative control)
where:
- mean cOD Negative Control = mean ODNC – mean ODblank
- mean cOD Test Item = mean ODTI – mean ODblank - Control samples:
- yes, concurrent no treatment
- yes, concurrent positive control
- Amount/concentration applied:
- Amount applied per tissue: 10 +/- 2 µL.
- Duration of treatment / exposure:
- Exposure period of 15 minutes, followed by rinsing
MTT-loading after a 42h-incubation period following rinsing. Observation of MTT-> formazan transformation by viable cells. - Number of replicates:
- Triplicate
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 79
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- In the preliminary tests, the test item was found not to have direct MTT reducing properties or colouring potential.
Main test: All acceptance criteria for the negative and positive controls were fulfilled. The study was therefore considered to be valid.
Following a 15 minutes exposure and 42 hours of recovery period, the relative mean viability of the tissues treated with the test item was 79% with a standard deviation of 15%.
As the mean viability was > 50% after the MTT reduction, the IL-1a concentrations inculture media samples retained from the three negative controls and the three test item-treated tissues were analyzed by ELISA.
The mean IL-1a concentration for treated tissues was 23.8 pg/mL. Due to this value being below 60 pg/mL, the results met the criteria for an in vitro classification as non-irritant to skin. - Other effects:
- no
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In vitro, the test item is considered to be non-irritant to the skin.
- Executive summary:
The objective of this study was to evaluate the skin irritation potential of the test item using the EpiskinTM reconstructed human epidermis model.
The study design was based upon international guidelines (OECD Guideline No. 439 and Commission Regulation (EC) No. 761/2009, B.46). The study was conducted in compliance with CiToxLAB France standard operating procedures and the principles of Good Laboratory Practice.
Methods
Preliminary tests were performed to detect the ability of the test item to directly reduce MTT as well as its colouring potential.
Following the preliminary tests, the skin irritation potential of the test item was tested in the main test. The test item and both the negative and positive controls were applied topically on triplicate tissues and incubated at room temperature for 15 minutes. At the end of the treatment period, each tissue was rinsed with D-PBS and incubated for 42 hours at 37°C, 5% CO2 in a humidified incubator. The cell viability was then assessed by means of the colourimetric MTT reduction assay.
Relative viability values were calculated for each tissue and expressed as a percentage of the mean viability of the negative control tissues which was set at 100% (reference viability).
In addition, the concentration of the inflammatory mediator IL-1awas evaluated in the culture medium retained following the 42-hour recovery period. This quantification, based on an ELISA assay, was performed since the mean relative viability of the test item-treated tissues was > 50% following the MTT reduction assay.
Results
Preliminary tests
In the preliminary tests, the test item was found not to have direct MTT reducing properties or colouring potential.
Main test
All acceptance criteria for the negative and positive controls were fulfilled. The study was therefore considered to be valid.
Following a 15 minutes exposure and 42 hours of recovery period, the relative mean viability of the tissues treated with the test item was 79% with a standard deviation of 15%.
As the mean viability was > 50% after the MTT reduction, the IL-1a concentrations inculture media samples retained from the three negative controls and the three test item-treated tissues were analyzed by ELISA.
The mean IL-1a concentration for treated tissues was 23.8 pg/mL. Due to this value being below 60 pg/mL, the results met the criteria for an in vitro classification as non-irritant to skin.
Conclusion
Under the experimental conditions of this study, the test item is considered to be non-irritant to skin.
According to the results of this study, the classification of the test item should be:
. not classified (Directive 67/548/EEC) and no category (Regulation (EC) No. 1272/2008).
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June / July 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- not GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach/Main, FRG
- Age at study initiation: not specified
- Weight at study initiation: 2.86 - 3.14 kg
- Housing: individually
- Diet (e.g. ad libitum): about 130 g per day per animal
- Water (e.g. ad libitum): about 250 ml per day per animal
- Acclimation period: at least 8 days bafore the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): air-conditionned without details
- Photoperiod (hrs dark / hrs light): 12/12
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 ml
- Observation period (in vivo):
- 1h, 24h, 48h, 72h, 8d, 15d, 21d after application
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- Single application to the conjunctival sac of the right eyelid ; the substance was not washed out.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21d
- Remarks on result:
- other: individual mean results: 1-1-1
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21d
- Remarks on result:
- other: individual mean results: 0-0.67-0.33
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21d
- Remarks on result:
- other: individual mean results: 2-2-2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21d
- Remarks on result:
- other: individual mean results: 2.3-2.3-2.3
- Irritant / corrosive response data:
- The test item showed signs of eye irritation, not fully reversible in 21 days.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Under the experimental conditions of this study, the test item was severely irritant with irreversible effects when administered by ocular route to rabbits.
- Executive summary:
The objective of this study was to evaluate the potential irritant properties of the test item for the eye following a single administration to rabbits.
The test item was administered to 3 rabbits. Ocular reactions were observed approximately 1, 24, 48 and 72 hours, 7, 14 and 21 days after the administration.
Local clinical signs were observed in rabbits: loss of cornea tissue (2 animals), pupil contracted (all), suppuration (2 animals), discharge of blood (2 animals), marginal vascularization of the cornea (2 animals), small retractions in the eyelids (all), bloody incrustation (1 animal).
Mean scores calculated for the 3 rabbits over 24, 48 and 72 hours were: 1 for corneal opacity (individual mean score: 1-1-1), 2.3 for chemosis (2.3-2.3-2.3), 0.33 for iritis (0-0.67-0.33) and 2 for redness of the conjunctiva (2-2-2).
The effects on cornea and conjunctiva are not fully reversible into 21 days.
Under the experimental conditions of this study, the test item was severely irritant with irreversible effects when administered by ocular route to rabbits.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In vitro skin irritation study (Gerbeix 2015a)
The objective of this study was to evaluate the skin irritation potential of the test item using the EpiskinTM reconstructed human epidermis model.
The study design was based upon international guidelines (OECD Guideline No. 439 and Commission Regulation (EC) No. 761/2009, B.46).
The test item and both the negative and positive controls were applied topically on triplicate tissues and incubated at room temperature for 15 minutes. At the end of the treatment period, each tissue was rinsed with D-PBS and incubated for 42 hours at 37°C, 5% CO2 in a humidified incubator. The cell viability was then assessed by means of the colourimetric MTT reduction assay. Relative viability values were calculated for each tissue and expressed as a percentage of the mean viability of the negative control tissues which was set at 100% (reference viability). In addition, the concentration of the inflammatory mediator IL-1awas evaluated in the culture medium retained following the 42-hour recovery period. This quantification, based on an ELISA assay, was performed since the mean relative viability of the test item-treated tissues was > 50% following the MTT reduction assay.
In the preliminary tests, the test item was found not to have direct MTT reducing properties or colouring potential. All acceptance criteria for the negative and positive controls were fulfilled. The study was therefore considered to be valid.
Following a 15 minutes exposure and 42 hours of recovery period, the relative mean viability of the tissues treated with the test item was 79% with a standard deviation of 15%. As the mean viability was > 50% after the MTT reduction, the IL-1a concentrations inculture media samples retained from the three negative controls and the three test item-treated tissues were analyzed by ELISA. The mean IL-1a concentration for treated tissues was 23.8 pg/mL. Due to this value being below 60 pg/mL, the results met the criteria for an in vitro classification as non-irritant to skin.
Under the experimental conditions of this study, the test item is considered to be non-irritant to skin.
In vivo skin irritation study (Kirsch 1989) :
The objective of this study was to evaluate the potential corrosive and irritant properties of the test item following dermal application on rabbits.
The test item was applied for 4 hours to a three rabbits with intact skin. No unscheduled deaths occurred during the study and no clinical signs were noted in any animals.
The body weight of the animals was unaffected by the test item treatment. After a 4-hour exposure (three animals), no erythema or edema were observed at 24 hours after exposure.
Based on this study on rabbits, the test item is considered to be not irritating to the skin.
In vivo eye irritation study in rabbit (Kirsch 1989):
The objective of this study was to evaluate the potential irritant properties of the test item for the eye following a single administration to rabbits.
The test item was administered to 3 rabbits. Ocular reactions were observed approximately 1, 24, 48 and 72 hours, 7, 14 and 21 days after the administration.
Local clinical signs were observed in rabbits: loss of cornea tissue (2 animals), pupil contracted (all), suppuration (2 animals), discharge of blood (2 animals), marginal vascularization of the cornea (2 animals), small retractions in the eyelids (all), bloody incrustation (1 animal).
Mean scores calculated for the 3 rabbits over 24, 48 and 72 hours were: 1 for corneal opacity (individual mean score: 1-1-1), 2.3 for chemosis (2.3-2.3-2.3), 0.33 for iritis (0-0.67-0.33) and 2 for redness of the conjunctiva (2-2-2).
The effects on cornea and conjunctiva are not fully reversible into 21 days.
Under the experimental conditions of this study, the test item was severely irritant with irreversible effects when administered by ocular route to rabbits.
In vitro eye irritation study (Gerbeix 2015b)
The objective of this study was to evaluate the potential irritant and corrosive properties of the test item to the eye. The Bovine Corneal Opacity and Permeability (BCOP) test method (OECD 437) can identify chemicals inducing serious eye damage and chemicals not requiring classification for eye irritation or serious eye damage.
Three corneas were used for each treated series (test item, positive control and negative control). The test item was applied undiluted, in a single experiment using a treatment time of 10 minutes and using the closed-chamber method. At the end of the incubation period, the optical density of the solution from the posterior chamber of each holder was measured in order to determine the permeability of the cornea. Each cornea was then observed for opaque spots and other irregularities.
Fluorescein fixation was observed on the corneas treated with the test item. All acceptance criteria were fulfilled. The study was therefore considered as valid.
The mean In Vitro Irritancy Score (IVIS) of the test item-treated corneas was: 3.
As the test item induced a mean IVIS = 3, the test item was considered as a test chemical not requiring classification for eye irritation or serious eye damage.
Justification for classification or non-classification
Based on the available data, 2 -Hydroxy-3 -phenoxy acrylate should be classified as eye corrosive (Eye Dam 1) according to the Regulation EC n°1272/2008.
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