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EC number: 205-413-1 | CAS number: 140-39-6
- 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
Skin Irritation:
The p-tolyl acetate (CAS No. 140-39-6) tested at 4% in petrolatum produced no irritation after a 48-hr closed-patch test in 25 human subjects.
Thus, based on the human experience data it was concluded that p-tolyl acetate (CAS No. 140-39-6) was non-Irritating to the skin of human subjects under the experimental conditions tested and being classified as “Category- Not Classified” as per CLP Regulation.
Eye Irritation:
The ocular irritation potential of p-tolyl acetate (CAS No: 140-39-6) was estimated using OECD QSAR toolbox version 3.4 with log Kow as the primary descriptor. p-tolyl acetate was estimated to be not irritating to the eyes of rabbits.Based on the estimated result, p-tolyl acetate (CAS No: 140-39-6) can be considered to be notirritating to the eyes and being classified as "Unclassified" as per CLP regulation.
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:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer-reviewed journal
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Skin irritation potentials of p-tolyl acetate (CAS No. 140-39-9) were investigated in rabbits.
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- Name of test material (as cited in study report): p-cresyl acetate
Molecular formula: C9H10O2
Molecular weight: 150.176 g/mol
Substance Type: Organic
Physical State: Liquid - Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- no data available
- Type of coverage:
- not specified
- Preparation of test site:
- other: intact and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- full strength
- Duration of treatment / exposure:
- no data available
- Observation period:
- no data available
- Number of animals:
- no data available
- Details on study design:
- no data available
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: no data available
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No irritation was observed.
- Interpretation of results:
- other: not irritating
- Conclusions:
- The substance p-tolyl acetate (CAS No.140-39-6) when administered to rabbits by the dermal route, is to be considered ―non-irritant for the skin.
- Executive summary:
Skin irritation potentials of p-tolyl acetate (CAS No. 140-39-9) were investigated in rabbits. p-tolyl acetate (CAS No.140-39-6) applied full strength on intact or abraded rabbit skin and effects were observed (duration not specified), produced no skin irritation. Hence, p-tolyl acetate (CAS No.140-39-6) was classified as non-irritating to skin.
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:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification
- Justification for type of information:
- Data is from OECD QSAR toolbox v3.4 and the supporting QMRF report has been attached.
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Prediction is done using OECD QSAR Toolbox version 3.4 with respect to the descriptor log Kow.
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- Name of test material (as cited in study report): 4-methylphenyl acetate
Molecular formula: C9H10O2
Molecular weight: 150.176 g/mol
Substance Type: Organic
Physical State: Liquid - Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- no data available
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 7 days
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- no data available
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No indication of irritation.
- Other effects:
- no data available
- Interpretation of results:
- other: not irritating
- Conclusions:
- p-tolyl acetate was estimated to be not irritating to the rabbit eyes.
- Executive summary:
The ocular irritation potential of p-tolyl acetate (CAS No: 140-39-6) was estimated using OECD QSAR toolbox version 3.4 with log Kow as the primary descriptor. p-tolyl acetate was estimated to be not irritating to the eyes of rabbits. Based on the estimated result, p-tolyl acetate (CAS No: 140-39-6) can be considered to be not irritating to the eyes and being classified as "Unclassified" as per CLP regulation.
Reference
Estimation
method: Takes mode value from the 5 nearest neighbours
Domain logical expression:Result: In Domain
(((((((("a"
or "b" or "c" or "d" or "e" )
and ("f"
and (
not "g")
)
)
and ("h"
and (
not "i")
)
)
and ("j"
and (
not "k")
)
)
and ("l"
and (
not "m")
)
)
and ("n"
and (
not "o")
)
)
and "p" )
and ("q"
and "r" )
)
Domain
logical expression index: "a"
Referential
boundary: The
target chemical should be classified as Esters (Acute toxicity) by
US-EPA New Chemical Categories
Domain
logical expression index: "b"
Referential
boundary: The
target chemical should be classified as Acetoxy AND Alkyl arenes AND
Aryl AND Carboxylic acid ester by Organic Functional groups
Domain
logical expression index: "c"
Referential
boundary: The
target chemical should be classified as Alkyl arenes AND Carboxylic acid
ester AND Overlapping groups by Organic Functional groups (nested)
Domain
logical expression index: "d"
Referential
boundary: The
target chemical should be classified as Aliphatic Carbon [CH] AND
Aliphatic Carbon [-CH2-] AND Aliphatic Carbon [-CH3] AND Aromatic Carbon
[C] AND Carbonyl, aliphatic attach [-C(=O)-] AND Ester, aromatic attach
[-C(=O)O] AND Miscellaneous sulfide (=S) or oxide (=O) AND Olefinic
carbon [=CH- or =C<] AND Oxygen, one aromatic attach [-O-] AND Oxygen,
two olefinic attach [-O-] by Organic functional groups (US EPA)
Domain
logical expression index: "e"
Referential
boundary: The
target chemical should be classified as Aromatic compound AND Carbonic
acid derivative AND Carboxylic acid derivative AND Carboxylic acid ester
by Organic functional groups, Norbert Haider (checkmol)
Domain
logical expression index: "f"
Referential
boundary: The
target chemical should be classified as AN2 AND AN2 >> Shiff base
formation after aldehyde release AND AN2 >> Shiff base formation after
aldehyde release >> Specific Acetate Esters AND SN1 AND SN1 >>
Nucleophilic attack after carbenium ion formation AND SN1 >>
Nucleophilic attack after carbenium ion formation >> Specific Acetate
Esters AND SN2 AND SN2 >> Acylation AND SN2 >> Acylation >> Specific
Acetate Esters AND SN2 >> Nucleophilic substitution at sp3 Carbon atom
AND SN2 >> Nucleophilic substitution at sp3 Carbon atom >> Specific
Acetate Esters by DNA binding by OASIS v.1.4
Domain
logical expression index: "g"
Referential
boundary: The
target chemical should be classified as AN2 >> Michael-type addition,
quinoid structures OR AN2 >> Michael-type addition, quinoid structures
>> Quinoneimines OR AN2 >> Michael-type addition on alpha,
beta-unsaturated carbonyl compounds OR AN2 >> Michael-type addition on
alpha, beta-unsaturated carbonyl compounds >> Four- and Five-Membered
Lactones OR AN2 >> Michael-type conjugate addition to activated alkene
derivatives OR AN2 >> Michael-type conjugate addition to activated
alkene derivatives >> Alpha-Beta Conjugated Alkene Derivatives with
Geminal Electron-Withdrawing Groups OR AN2 >> Nucleophilic addition to
alpha, beta-unsaturated carbonyl compounds OR AN2 >> Nucleophilic
addition to alpha, beta-unsaturated carbonyl compounds >> Alpha,
Beta-Unsaturated Aldehydes OR AN2 >> Schiff base formation OR AN2 >>
Schiff base formation >> Alpha, Beta-Unsaturated Aldehydes OR AN2 >>
Schiff base formation by aldehyde formed after metabolic activation OR
AN2 >> Schiff base formation by aldehyde formed after metabolic
activation >> Geminal Polyhaloalkane Derivatives OR AN2 >> Shiff base
formation for aldehydes OR AN2 >> Shiff base formation for aldehydes >>
Haloalkane Derivatives with Labile Halogen OR No alert found OR
Non-covalent interaction OR Non-covalent interaction >> DNA
intercalation OR Non-covalent interaction >> DNA intercalation >> DNA
Intercalators with Carboxamide and Aminoalkylamine Side Chain OR
Non-covalent interaction >> DNA intercalation >> Organic Azides OR
Radical OR Radical >> Radical mechanism by ROS formation OR Radical >>
Radical mechanism by ROS formation >> Organic Azides OR Radical >>
Radical mechanism via ROS formation (indirect) OR Radical >> Radical
mechanism via ROS formation (indirect) >> Geminal Polyhaloalkane
Derivatives OR Radical >> Radical mechanism via ROS formation (indirect)
>> Nitroarenes with Other Active Groups OR Radical >> Radical mechanism
via ROS formation (indirect) >> Nitrophenols, Nitrophenyl Ethers and
Nitrobenzoic Acids OR Radical >> Radical mechanism via ROS formation
(indirect) >> p-Substituted Mononitrobenzenes OR Radical >> Radical
mechanism via ROS formation (indirect) >> Single-Ring Substituted
Primary Aromatic Amines OR Radical >> Radical mechanism via ROS
formation (indirect) >> Thiols OR Radical >> ROS formation after GSH
depletion (indirect) OR Radical >> ROS formation after GSH depletion
(indirect) >> Quinoneimines OR SN1 >> Carbenium ion formation OR SN1 >>
Carbenium ion formation >> Alpha-Haloethers OR SN1 >> Nucleophilic
attack after diazonium or carbenium ion formation OR SN1 >> Nucleophilic
attack after diazonium or carbenium ion formation >> Nitroarenes with
Other Active Groups OR SN1 >> Nucleophilic attack after nitrene
formation OR SN1 >> Nucleophilic attack after nitrene formation >>
Organic Azides OR SN1 >> Nucleophilic attack after nitrenium ion
formation OR SN1 >> Nucleophilic attack after nitrenium ion formation >>
Single-Ring Substituted Primary Aromatic Amines OR SN1 >> Nucleophilic
attack after reduction and nitrenium ion formation OR SN1 >>
Nucleophilic attack after reduction and nitrenium ion formation >>
Nitroarenes with Other Active Groups OR SN1 >> Nucleophilic attack after
reduction and nitrenium ion formation >> Nitrophenols, Nitrophenyl
Ethers and Nitrobenzoic Acids OR SN1 >> Nucleophilic attack after
reduction and nitrenium ion formation >> p-Substituted Mononitrobenzenes
OR SN2 >> Acylation involving a leaving group OR SN2 >> Acylation
involving a leaving group >> Haloalkane Derivatives with Labile Halogen
OR SN2 >> Acylation involving a leaving group after metabolic activation
OR SN2 >> Acylation involving a leaving group after metabolic activation
>> Geminal Polyhaloalkane Derivatives OR SN2 >> Alkylation OR SN2 >>
Alkylation >> Alkylphosphates, Alkylthiophosphates and Alkylphosphonates
OR SN2 >> Alkylation, direct acting epoxides and related OR SN2 >>
Alkylation, direct acting epoxides and related >> Epoxides and
Aziridines OR SN2 >> Alkylation, nucleophilic substitution at sp3-carbon
atom OR SN2 >> Alkylation, nucleophilic substitution at sp3-carbon atom
>> Haloalkane Derivatives with Labile Halogen OR SN2 >> Alkylation,
nucleophilic substitution at sp3-carbon atom >> Sulfonates and Sulfates
OR SN2 >> Alkylation, ring opening SN2 reaction OR SN2 >> Alkylation,
ring opening SN2 reaction >> Four- and Five-Membered Lactones OR SN2 >>
Direct acting epoxides formed after metabolic activation OR SN2 >>
Direct acting epoxides formed after metabolic activation >> Quinoline
Derivatives OR SN2 >> Nucleophilic substitution at sp3 carbon atom after
thiol (glutathione) conjugation OR SN2 >> Nucleophilic substitution at
sp3 carbon atom after thiol (glutathione) conjugation >> Geminal
Polyhaloalkane Derivatives OR SN2 >> SN2 at an activated carbon atom OR
SN2 >> SN2 at an activated carbon atom >> Quinoline Derivatives OR SN2
>> SN2 at sp3-carbon atom OR SN2 >> SN2 at sp3-carbon atom >>
Alpha-Haloethers OR SN2 >> SN2 attack on activated carbon Csp3 or Csp2
OR SN2 >> SN2 attack on activated carbon Csp3 or Csp2 >> Nitroarenes
with Other Active Groups by DNA binding by OASIS v.1.4
Domain
logical expression index: "h"
Referential
boundary: The
target chemical should be classified as (!Undefined)Group All Lipid
Solubility < 0.01 g/kg by Eye irritation/corrosion Exclusion rules by BfR
Domain
logical expression index: "i"
Referential
boundary: The
target chemical should be classified as (!Undefined)Group CN Lipid
Solubility < 0.4 g/kg OR (!Undefined)Group CNHal Lipid Solubility < 400
g/kg OR Group All Aqueous Solubility < 0.000005 g/L OR Group All Aqueous
Solubility < 0.00002 g/L OR Group All log Kow > 9 OR Group All Melting
Point > 200 C OR Group C Aqueous Solubility < 0.0001 g/L OR Group C
Aqueous Solubility < 0.0005 g/L OR Group C Melting Point > 55 C OR Group
C Molecular Weight > 380 g/mol OR Group CHal log Kow > 4.5 OR Group CHal
Melting Point > 65 C OR Group CHal Molecular Weight > 280 g/mol OR Group
CHal Molecular Weight > 370 g/mol OR Group CN Aqueous Solubility < 0.1
g/L OR Group CN Molecular Weight > 290 g/mol by Eye irritation/corrosion
Exclusion rules by BfR
Domain
logical expression index: "j"
Referential
boundary: The
target chemical should be classified as No alert found by in vitro
mutagenicity (Ames test) alerts by ISS
Domain
logical expression index: "k"
Referential
boundary: The
target chemical should be classified as alpha,beta-unsaturated aliphatic
alkoxy group by in vitro mutagenicity (Ames test) alerts by ISS
Domain
logical expression index: "l"
Referential
boundary: The
target chemical should be classified as Group 14 - Carbon C AND Group 16
- Oxygen O by Chemical elements
Domain
logical expression index: "m"
Referential
boundary: The
target chemical should be classified as Group 15 - Nitrogen N OR Group
15 - Phosphorus P OR Group 17 - Halogens Br OR Group 17 - Halogens
F,Cl,Br,I,At by Chemical elements
Domain
logical expression index: "n"
Referential
boundary: The
target chemical should be classified as Aromatic compound AND Carbonic
acid derivative AND Carboxylic acid derivative AND Carboxylic acid ester
by Organic functional groups, Norbert Haider (checkmol)
Domain
logical expression index: "o"
Referential
boundary: The
target chemical should be classified as Carboxylic acid anhydride OR
Dialkylether OR Ether OR Heterocyclic compound by Organic functional
groups, Norbert Haider (checkmol)
Domain
logical expression index: "p"
Similarity
boundary:Target:
Cc1ccc(OC(C)=O)cc1
Threshold=30%,
Dice(Atom centered fragments)
Atom type; Count H attached; Hybridization
Domain
logical expression index: "q"
Parametric
boundary:The
target chemical should have a value of log Kow which is >= 1.74
Domain
logical expression index: "r"
Parametric
boundary:The
target chemical should have a value of log Kow which is <= 2.57
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation:
In different studies, p-tolyl acetate has been investigated for potential for dermal irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits along with human data for target chemical p-tolyl acetate and its functionally similar read across substances benzyl propionate (CAS No. -122-63-4) and benzyl acetate(CAS: 140-11-4). The predicted data using the OECD QSAR toolbox has also been compared with the experimental data.
Various studies for p-tolyl acetate were summarized in Food and Cosmetics Toxicology, Volume 12, Issue 3, June 1974, Page 391 to assess the irritation in humans and rabbits.
p-tolyl acetate applied at full strength on intact or abraded rabbit skin, produced no irritation. Also, when tested in 25 human subjects at 4% in petrolatum in a 48-hr closed-patch test, p-tolyl acetate produced no irritation.
In a prediction done by SSS (2017), the skin irritation potential of p-tolyl acetate (CAS No: 140-39-6) was estimated using OECD QSAR toolbox version 3.4 with log Pow as the primary descriptor and considering the seven closest read across substances. The substance p-tolyl acetate was estimated to be not irritating to the skin of New Zealand White rabbits.
Also these results are further supported by the experimental study conducted in an OECD GLP laboratory by Sustainability Support Services (Europe) AB for the functionally similar read across substance benzyl Propionate (CAS: 122-63-4).This study was performed as per OECD guideline No. 404. Three healthy young adult female rabbits were used for conducting acute dermal irritation study. Body weights were recorded on day 0 (prior to application) and at termination. Rabbits with good intact skin were selected for the study. The hairs of all the rabbits were clipped at contralateral sites, approximately 24 hours prior to treatment. A dose of0.5 ml of test item (as such) was applied to the skin, over an area of approximately 6 x 6 cm clipped of hair on one side of rabbits. The other untreated side was kept as control area and 0.5 ml of distilled water was applied at this site. At the end of 4 hours, the gauze patch was removed and test item application site was wiped with water without altering the integrity of the epidermis. Initially, the test item was applied to the clipped area of skin of one rabbit. The test site was covered with gauze patch. After 4 hours of exposure in Animal No. 1, there was no erythema and oedema observed at 1, 24, 48 and 72 hours observation. Hence the confirmatory test was conducted on additional two rabbits (No. 2 and 3)to confirm the non irritant nature of the test item. In Animals No. 2 and 3 after post patch removal, revealed no erythema and oedema at 1, 24, 48 and 72 hours observation. The patch was removed after 4 hours and rabbits were observed for erythema and oedema at 1, 24, 48 and 72 hours after patch removal, evaluated and graded as per Draize method. The individual mean score at 24, 48 and 72 hours for Animal Nos. 1, 2 and 3 were 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00, for erythema and oedema formation, respectively.
Hence, it was concluded that “Benzyl propionate (CAS No. - 122 -63-4)” was Non-Irritating to the skin of Female New Zealand White rabbits under the experimental conditions tested.
The above results are further supported by the experimental study performed by P.J Frosch, et al., (Contact Dermatitis, vol 33,Pages 333-342,1995) for the functionally similar read across substance benzyl Acetate (CAS: 140-11-4). The patch test was performed on human subjects to assess the irritation potential of benzyl acetate (CAS No: 140 -11 -4). One hundred patients were patch tested with 1 or 5% benzyl acetate in petrolatum, using Finn Chambers on Scanpor applied for 2 days to the back. Scoring was done on the day the patch was removed and 1 or 2 days later. A weak positive response was seen in one patient given the 1% concentration. There were no effects in the 5% group. Thus, based on the human experience data it was concluded that benzyl acetate (CAS No. 140-11-4) was non-Irritating to the skin of human subjects under the experimental conditions tested.
On the basis of human and animal data for the target as well as it read across substances, it was concluded that p-tolyl acetate (CAS No. 140-39-6) was non-Irritating to the skin of human subjects and animals under the experimental conditions tested and being classified as “Category- Not Classified” as per CLP Regulation.
Eye Irritation:
In different studies, p-tolyl acetate has been investigated for potential for ocular irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits along with predicted data for target chemical p-tolyl acetate and its functionally similar read across substances benzyl propionate (CAS No. - 122-63-4) and n-butylacetate (CAS: 123-86-4). The predicted data using the OECD QSAR toolbox has also been compared with the experimental data.
The ocular irritation potential of p-tolyl acetate (CAS No: 140-39-6) was estimated by SSS(2017) using OECD QSAR toolbox version 3.4 with log Kow as the primary descriptor. p-tolyl acetate was estimated to be not irritating to the eyes of rabbits.
Also the above study is supported by the Acute Eye Irritation/Corrosion Study of functionally similar read across substance benzyl propionate (CAS no. - 122-63-4) in Rabbits, conducted by Sustainability Support Services (Europe) AB at SA-FORD (Sanctuary for Research and Development), Maharashtra, India. This study was performed as per OECD guideline No. 405.
Rabbits free from injury of eye were selected for the study. The eyes of all the rabbits were examined 24 hours prior to treatment. One eye of each rabbit served as control and other as treated. Control eye was left untreated whereas;0.1 ml of test item (as such)was instilled in the other (treated) eye of rabbits.The eye was observed at 1, 24, 48, 72 hours after test item instillation.Ophthalmoscope was used for scoring of eye lesions.
In the initial test,0.1 ml of test itemwas applied into the conjunctival sac of the right eye of Animal No.1. The left eye of the rabbit served as the control. Animal No. 1 presented ocular lesions at 1 hour observation period. Hence the confirmatory test was conducted on additional two rabbits (Animal No. 2 and 3);0.1 ml of test itemwas instilled into the conjunctival sac of right eye and left eye served as the control. Ocular lesions were observed at 1, 24 and 48 hour in Animal Number 2 whereas in Animal Number 3 ocular lesions presented only at 1 hour observation period.
Untreated eye of the treated rabbits was normal throughout the experimental period of 72 hours.
The following grading scores were observed in treated eye of tested rabbits.
Observation at 1 hour after instillation of test item revealed: Cornea-No ulceration or opacity in all 3 animals; Area of Opacity-Zero in all the animals;Iris:Normal in all the animals.Conjunctivae -Some blood vessels definitely hyperaemic (injected) in all the animals;Chemosis:Some swelling above normal (includes nictating membranes) were observed in animal number 1 and 3 whereas animal number 2 was normal.
Observation at 24 hours after instillation of test item revealed: Cornea-No ulceration or opacity in all the animals; Area of Opacity-Zero in all the animals;Iris:Normal in all the animals.Conjunctivae -Some blood vessels definitely hyperaemic (injected) was observed in animal no. 2. Animal no. 1 and 3 recovered to normal;Chemosis:No swelling was observed in all the Animals.
At 24 hours observation the rabbits were examined for corneal epithelium cell damage using sodium fluorescein strips and noticed 0 % damage in Animal Nos 1, 2 and 3, respectively.
Observation at 48 and 72 hours after instillation of test item revealed: Cornea-No ulceration or opacity in all the animals; Area of Opacity-Zero in all the animals;Iris:Normal in all the animals.Conjunctivae -Some blood vessels definitely hyperaemic (injected) was observed in animal no. 3 at 48 hours which was recovered to normal at 72 hours observation whereas blood vessels were normal in Animal Numbers 1 and 3 at 48 and 72 hours observation;Chemosis:No swelling was observed in all the animals.
The individual mean score for Animal Nos. 1, 2 and 3at 24, 48, 72 hoursfor Corneal opacity, iris, conjunctiva, chemosis were found 0.00, 0.00, 0.00, 0.00 ; 0.00, 0.00, 0.67, 0.00 and 0.00, 0.00, 0.00, 0.00, respectively.
Under the experimental conditions tested, eye irritation and reversibility of effects on eyes of rabbits was observed at 72 hours.
Hence under the experimental test conditions, Benzyl propionate (CAS No. - 122-63-4) is “Non Irritant” to New Zealand White Male rabbit eyes.
In addition to these studies, the experimental study was conducted by ECETOC (ECETOC Technical Report no. 48 (2), 1998) for the functionally similar read across substance n-butyl acetate (CAS: 123-86-4). Study was carried out according to OECD 405 “EYE IRRITATION” Guidelines. 0.1 ml of n-butyl acetate was instilled into the conjunctival sac of 4 New Zealand White rabbits. Observations were made after 1 hour, 4 hours and then 1, 2, 3 and 7 days after instillation of test chemical. The scoring was done according to the Draize method. Conjunctival redness and chemosis was observed in all animals after 1 day of observation. The MMAS (Maximum Modified Average Score) of n-butyl acetate was 7.5 after 1 day of observation. The effects were recovered fully after 7 days and the MMAS scores were 0.0.
Based on the classification of chemicals according to MMAS scores, n-butyl acetate can be considered to be not irritating to rabbit eyes
Moreover, these studies are further supported by the experimental study summarized in Concise International Chemical Assessment Document 64 - BUTYL ACETATES, World Health Organization, Geneva, 2005,for the functionally similar read across substance n-butyl acetate (CAS: 123-86-4). 0.1 ml of n-butyl acetate (123-86-4) was instilled into the eyes of 6 rabbits and the effects were observed. Iritis and minor to moderate conjunctivitis were observed which healed fully within 48 hours, but no corneal damage was observed. A maximum Draize score of 14.7 /110 (occurring at 4 hours) was noted when n-butyl acetate was tested in rabbits. Based on the Draize scores, n-butyl acetate can be considered to be not irritating to eyes.
On the basis of the above available data for the target as well as it read across substances; and by applying the weight of evidence approach, it can be concluded that p-tolyl acetate (CAS No: 140-39-6) can be considered to be not irritating to the eyes and being classified as "Unclassified" as per CLP regulation.
Justification for classification or non-classification
According to CLP Regulation EC No. 1272/2008 and based on the studies of skin and eye irritation, it is concluded that the substance p-tolyl acetate is not classified as skin and eye irritant.
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