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EC number: 203-074-4 | CAS number: 103-05-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Skin irritation/corrosion: Not irritating (Similar to OECD 404/GLP)
Serious eye damage/eye irritation (in vitro):
In vitro eye irritation test in isolated chicken eyes (ICE): Inconclusive (OECD 438/GLP)
The result of the in vitro eye irritation test was not conclusive so read-across was performed to an in vivo eye irritation study in rabbits from PEA(CAS No. 60 -12 -8).
Read-across from PEA - Serious eye damage/eye irritation (in vivo): Irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8 -`15th November 1988 (experimental phase)
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source of test material: Givaudan - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gorseside Rabbits, Northchurch, Berkhamsted, Herfordshire, UK
- Age at study initiation: 10-12 weeks on arrival
- Weight at study initiation: 2kg
- Housing: individually in grid bottomed metal cages
- Diet: Commerically available antobiotic free rabbit diet (SQC standard rabbit pellets) ad libitum
- Water: Mains drinking water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 5-24°C. Temperature was typically greater than 14°C duing study period.
- Humidity (%): 37-68%
- Photoperiod (hrs dark / hrs light): 12 light/dark
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72 hrs and 7 days
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal skin on the trunk clipped free of hair. Left flank and immediately caudal to the last rib.
- % coverage: 6 sq.cm
- Type of wrap if used: Elastoplast elastic adhesive bandage 10cm wide
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Treated sites cleansed by gentle swabbing with cotton wool soeaked in warm water
- Time after start of exposure: 4 hrs
OBSERVATION TIME POINTS
1, 24, 48, 72 hrs and 7 days
SCORING SYSTEM:
- Method of calculation: Draize - Irritation parameter:
- erythema score
- Basis:
- animal: 1, 3
- Time point:
- 24 h
- Score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 0.5
- Irritation parameter:
- edema score
- Basis:
- animal: 1, 2, 3
- Time point:
- 24 h
- Score:
- 0.5
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1.5
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 2
- Remarks on result:
- other: Minimal dequamation
- Irritation parameter:
- erythema score
- Basis:
- animal: 3, 4
- Time point:
- 48 h
- Score:
- 1
- Irritation parameter:
- edema score
- Basis:
- animal: 1, 4
- Time point:
- 48 h
- Score:
- 0.5
- Irritation parameter:
- edema score
- Basis:
- animal: 2, 3
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 1
- Remarks on result:
- other: Slight desquamation
- Irritation parameter:
- erythema score
- Basis:
- animal: 3, 4
- Time point:
- 72 h
- Score:
- 1
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 1
- Irritation parameter:
- edema score
- Basis:
- animal: 2, 3
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0.5
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a primary dermal irritation study in rabbits, DMPEC was not a skin irritant.
- Executive summary:
In a primary dermal irritation study (A/S/12895-12918), 4 female rabbits were dermally exposed (semi-occlusive) to 0.5mL of DMPEC for 4 hours. Animals then were observed for 7 days after dosing. Irritation was scored by the method of Draize.
The average scores calculated from the numerical values given to the irritation observed at the 24, 48 and 72 hour observations were 1.3 for erythema and 0.3 for oedema. Therefore the substance DMPEC is not a skin irritant based on the specific guidance adopted by the UNSCEGHS in June 2011.
This in vivo skin irritation/corrosion study in the rabbit is acceptable and satisfies the guideline requirement for an OECD 404 study.
Reference
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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- Please see read-across justification.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- other: cornela necrosis
- Basis:
- mean
- Time point:
- other: Only 24 hr timepoint
- Score:
- 8
- Max. score:
- 10
- Reversibility:
- not specified
- Interpretation of results:
- other: Irritating
- Conclusions:
- Phenylethyl Alcohol is an irritant to rabbit eyes.
- Executive summary:
In an eye irritation study (Carpenter et al., 1974) Phenylethyl Alcohol (undiluted) was applied to the centre of the cornea of 5 albino rabbits. The eye was examined in strong diffuse daylight 18 - 24 hours later, stained with fluorescein, and the injury scored. No vehicle was used.
Eye injury was graded according to the following 10-point scale based upon the degree of corneal necrosis that resulted. The corneal injury in rabbits was indicated as 8 out of 10. Based on the results of this study, Phenylethyl Alcohol was considered to be an eye irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion
There is one in vivo skin irritation test in rabbits available.
In a primary dermal irritation study (similar to OECD404/GLP), 4 female rabbits were dermally exposed (semi-occlusive) to 0.5mL of DMPEC for 4 hours. Animals then
were observed for 7 days after dosing. Irritation was scored by the method of Draize. The average scores calculated from the numerical values given to the irritation observed
at the 24, 48 and 72 hour observations were 1.3 for erythema and 0.3 for oedema. According to the Guidance on the Application of the CLP Criteria (v5.0, 2017), for existing
test data with more than three animals, specific guidance adopted by the UNSCEGHS in June 2011 needs to be applied. In the case of 4 rabbits the following applies:
a. Classification as skin corrosive – Category 1 if destruction of skin tissue (visible necrosis through the epidermis and into the dermis) occurs in at least one animal after exposure up to 4 hours.
b. Classification as skin irritant – Category 2 if at least 3 out of 4 rabbits show a mean score per animal of ≥ 2.3 ≤ 4.0 for erythema/eschar or for oedema.
Therefore the substance DMPEC is not a skin irritant based on these criteria. The results from this study are acceptable to use in the human health risk assessment.
Serious eye damage/eye irritation
There is one in vitro eye irritation test in isolated chicken eyes available. There is a read-across in vivo eye irritation study in rabbits from PEA available.
In an in vitro eye irritation test in isolated chicken eyes (ICE) assay (OECD 438/GLP), isolated chicken eyes were exposed to DMPEC (99.7%) for 10 seconds. Physiological
saline (0.9% (w/v) NaCl) was used for the negative control and 5% (w/v) Benzalkonium chloride solution was used for the positive control. The control eyes and test eyes were evaluated pre-treatment and at approximately 30, 75, 120, 180 and 240 minutes after the post-treatment rinse. Corneal thickness and corneal opacity were measured at all time points. Fluorescein retention was measured on two occasions, at baseline (t=0) and approximately 30 minutes after the post-treatment rinse. No significant corneal swelling (mean ≤5%) was observed during the four-hour observation period on test item treated eyes. Slight corneal opacity change (severity 0.5 or 1) was noted on three eyes. Severe fluorescein retention change (severity 3) was observed. No other corneal effect was observed. The positive and negative controls gave the appropriate responses. The ICE classes for DMPEC were: 1xI (mean corneal swelling) 1xII (mean corneal opacity) 1xIV (mean fluorescein retention). DMPEC did not meet any of the criteria for Eye damage – Category 1. DMPEC did not meet all the criteria for Not classified (i.e. it was false that 3 endpoints were classed as I or 2 endpoints were classed as I and 1 endpoint classed as II. Based on this in vitro eye irritation in the isolated chicken eyes test with DMPEC, the test item is not classified as a severe irritant and not classified as non-irritant.
There are 2 further in vitro tests that were considered to obtain a conclusive result – OECD 437 (Bovine Corneal Opacity and Permeability (BCOP)) and OECD 492 (Reconstructed human Cornea-like Epithelium (RhCE) test). The former allows identification of chemicals with a classification of ‘Eye Damage 1’ or ‘Not Classified’ similar to OECD 438, so was not considered further. The OECD 492 allows the identification of chemicals not requiring classification and labelling for eye irritation or serious eye damage i.e. ‘Not Classified’. Based on the results of the OECD 438 study with DMPEC, it is unlikely that the substance is not irritating to the eyes (slight corneal opacity change (severity 0.5 or 1) was noted on three eyes; severe fluorescein retention change (severity 3) was observed) so performing OECD 492 was not considered. The RIFM expert panel performed an evaluation of 18 AAA fragrance ingredients for eye irritation (DMPEC was one the substances in this group though there are no eye irritation studies available). Together the studies showed that the undiluted materials cause moderate to severe eye irritation. Based on the in vitro results and RIFM opinion, it was concluded that DMPEC is likely irritating to the eye (‘Eye irritation – Category 2). Currently there is no in vitro eye irritation test that allows identification of chemicals with a classification of ‘Eye irritation – Category 2’. To avoid animal testing, read-across was performed to an in vivo eye irritation study in rabbits from PEA.
In an eye irritation study (no guideline), PEA (undiluted) was applied to the centre of the cornea of 5 albino rabbits. The eye was examined in strong diffuse daylight 18 - 24 hours later, stained with fluorescein, and the injury scored. No vehicle was used. Eye injury was graded according to the following 10-point scale based upon the degree of corneal necrosis that resulted. The corneal injury in rabbits was indicated as 8 out of 10. Based on the results of this study, PEA was considered to be an eye irritant. DMPEC was predicted to be an eye irritant (Eye irritation – Category 2) based on the weight of evidence.
The results from this study are acceptable to use in the human health risk assessment.
In an eye irritation study (Carpenter et al., 1974) Phenylethyl Alcohol (undiluted) was applied to the centre of the cornea of 5 albino rabbits. The eye was examined in strong diffuse daylight 18 - 24 hours later, stained with fluorescein, and the injury scored. No vehicle was used.
Eye injury was graded according to the following 10-point scale based upon the degree of corneal necrosis that resulted. The corneal injury in rabbits was indicated as 8 out of 10. Based on the results of this study, Phenylethyl Alcohol was considered to be an eye irritant.
Justification for classification or non-classification
Based on the available information in the dossier, the substance DMPEC (CAS No. 103-05-9) is classified as Eye irritation Category 2 for serious eye damage/eye irritation based on the results of the read-across study from Phenethyl alcohol (CAS No. 60 -12 -8) and does not need to classified for skin irritation/corrosion when considering the criteria outlined in Annex I of 1272/2008/EC.
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