Registration Dossier

Administrative data

Description of key information

Skin irritation:

Preliminary irritation tests for test chemicalPhenethyl salicylate(CAS No:87-22-9)were performed on male albino Dunkin/Hartley guinea pigs to determine the concentration for suitable the sensitization study.In the preliminary test, the guinea pigs were treated intradermally and dermally.The animals were intradermally injected with0.1ml aliquots of a range of concentration of test substance (0.25%,0.5%, 1% or 2%)in 6% acetone/20% PEG400/0.01% Tween 80/saline.During topical application, animals received a single dermal application of 10%, 25% or 50% phenethyl salicylate in acetone using 8 mm saturated filter paper and 11 mm aluminum patch test cups which were applied to the shaved flank for 24 h. Reactions were assessed for irritation at 24 and 48 h after patch removal.Very slight erythema was observed at 0.25% and 0.5%. Barely perceptible erythema was observed at 10%, 25% or 50% concentrations.Since the test chemical induced cutaneous effects at these concentrations, thePhenethyl salicylate(CAS No:87-22-9) was considered to be slightly irritating to the skin of albino Dunkin/Hartley guinea pigs. Thus concentration of 0.5% was selected for the intradermal induction and a concentration of 50% phenethyl salicylate was selected for the topical induction application.

 

 

Eye irritation:

The ocular irritation potential ofPhenethyl salicylate(CAS No:87-22-9) was estimated using OECD QSAR toolbox version 3.3 with logPow as the primary descriptor. The substance Phenethylsalicylate(CAS No:87-22-9) was estimated to be not irritating into the eyes of Vienna White rabbits. Based on the estimated resultPhenethyl salicylate(CAS No:87-22-9) can be considered to be not irritating to eye and can be classified under the category ˋ Not Classified’ as per CLP regulation.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Data is from experimental report
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Preliminary irritation tests for test chemical Phenethyl salicylate (CAS No: 87-22-9) were performed in male Albino Dunkin/Hartley guinea pigs to determine the concentration for suitable the sensitization study.
GLP compliance:
not specified
Specific details on test material used for the study:
- IUPAC name: 2-phenylethyl 2-hydroxybenzoate
- Common name: Phenethyl Salicylate
- Molecular formula: C15H14O3
- Molecular weight : 242.2726 g/mol
- Smiles notation : c1ccc(cc1)CCOC(=O)c2ccccc2O
- InChl: 1S/C15H14O3/c16-14-9-5-4-8-13(14)15(17)18-11-10-12-6-2-1-3-7-12/h1-9,16H,10-11H2
- Substance type:Organic
- Physical state: Solid
- Physical apperance: white crystals
Species:
guinea pig
Strain:
other: Albino Dunkin/Hartley
Details on test animals and environmental conditions:
- Weight at study initiation: 320 g (intradermal exposure ) and 450g (dermal exposure )
- Diet (e.g. ad libitum): RGP pellets, hay cabbage ad libitum
- Water (e.g. ad libitum): water ad libitum
Type of coverage:
occlusive
Preparation of test site:
other: Intradermal application: clipped flanks Dermal application: shaved flanks
Vehicle:
other: Intradermal application: 6% acetone/20% PEG400/0.01% Tween 80/saline Dermal application: acetone
Controls:
not specified
Amount / concentration applied:
Intradermal concentration: 0.25%,0.5%, 1% or 2%
Topical Concentration: 10%, 25% or 50%
Duration of treatment / exposure:
Single application
Observation period:
24 and 48 hours
Number of animals:
4 (same sex)
Details on study design:
Area of exposure: shaved flanks

- % coverage: 8mm diameter filter paper patches in 11mm aluminum patch test cups are saturated with a range of concentrations of test chemical.
- Type of wrap if used: the patches are held in place by adhesive plaster ound around the trunk.
- Time after start of exposure: 24 and 48 hours after removal of the patches.

SCORING SYSTEM: the resulting reactions are scored for irritation on a scale from 0 to +++. (mentioned in table 1)
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48 h
Reversibility:
not specified
Remarks on result:
other: Very slight erythema was observed at 0.25% and 0.5% . Barely perceptible erythema was observed at 10%, 25% or 50% concentrations
Irritant / corrosive response data:
Very slight erythema was observed at 0.25% and 0.5% . Barely perceptible erythema was observed at 10%, 25% or 50% concentrations

Table 1.Skin Reaction Scoring System

SKIN REACTIONS

SCORES

No reaction

0

Barely perceptible erythema

±

Scattered, mild erythema (faint pink)

+

Moderate and diffuse erythema (pale pink )

++

Intense erythema (deep pink) and oedema

+++

Table 2: RESULTS OF PRELIMINARY IRRITATION TEST

Guinea pigs

Concentrations

No.

Sex

10%

25%

50%

24 hr

48 hr

24 hr

48 hr

24 hr

48 hr

1

M

0

0

±

±

±

±

2

M

0

0

0

0

±

±

3

M

±

0

±

±

±

4

M

0

0

±

0

0

0

Interpretation of results:
other: Slightly Irritating
Conclusions:
The test material Phenethyl salicylate (CAS No: 87-22-9) was considered to be slightly irritating on male albino Dunkin/Hartley guinea pigs in the preliminary irritation tests performed for the sensitization study.
Executive summary:

Preliminary irritation tests for test chemicalPhenethyl salicylate(CAS No:87-22-9)were performed on male albino Dunkin/Hartley guinea pigs to determine the concentration for suitable the sensitization study.

 

In the preliminary test, the guinea pigs were treated intradermally and dermally. The animals were intradermally injected with0.1ml aliquots of a range of concentration of test substance (0.25%,0.5%, 1% or 2%)in 6% acetone/20% PEG400/0.01% Tween 80/saline.

 

During topical application, animals received a single dermal application of 10%, 25% or 50% phenethyl salicylate in acetone using 8 mm saturated filter paper and 11 mm aluminum patch test cups which were applied to the shaved flank for 24 h. Reactions were assessed for irritation at 24 and 48 h after patch removal.

 

Very slight erythema was observed at 0.25% and 0.5% . Barely perceptible erythema was observed at 10%, 25% or 50% concentrations.

 

Since the test chemical induced cutaneous effects at these concentrations, thePhenethyl salicylate(CAS No:87-22-9) was considered to be slightly irritating to the skin of albino Dunkin/Hartley guinea pigs. Thus concentration of 0.5% was selected for the intradermal induction and a concentration of 50% phenethyl salicylate was selected for the topical induction application.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
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 version 3.3 and QMRF report has been attached
Qualifier:
according to
Guideline:
other: estimated data
Principles of method if other than guideline:
Prediction is done using QSAR Toolbox version 3.3
GLP compliance:
not specified
Specific details on test material used for the study:
- IUPAC name: 2-phenylethyl 2-hydroxybenzoate
- Common name: Phenethyl Salicylate
- Molecular formula: C15H14O3
- Molecular weight : 242.2726 g/mol
- Smiles notation : c1ccc(cc1)CCOC(=O)c2ccccc2O
- InChl: 1S/C15H14O3/c16-14-9-5-4-8-13(14)15(17)18-11-10-12-6-2-1-3-7-12/h1-9,16H,10-11H2
- Substance type:Organic
- Physical state: Solid
- Physical apperance: white crystals
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
no data available
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
no data available
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
no data available
Details on study design:
no data available
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
no eye irritating effects were observed.

Estimation method: Takes mode value from the 5 nearest neighbours
Domain  logical expression:Result: In Domain

((((((("a" or "b" or "c" or "d" )  and ("e" and ( not "f") )  )  and ("g" and ( not "h") )  )  and ("i" and ( not "j") )  )  and "k" )  and ("l" and ( not "m") )  )  and ("n" and "o" )  )

Domain logical expression index: "a"

Referential boundary: The target chemical should be classified as Esters (Acute toxicity) AND Phenols (Acute toxicity) by US-EPA New Chemical Categories

Domain logical expression index: "b"

Referential boundary: The target chemical should be classified as Michael addition AND Michael addition >> P450 Mediated Activation to Quinones and Quinone-type Chemicals AND Michael addition >> P450 Mediated Activation to Quinones and Quinone-type Chemicals >> Arenes by DNA binding by OECD

Domain logical expression index: "c"

Referential boundary: The target chemical should be classified as Strong binder, OH group by Estrogen Receptor Binding

Domain logical expression index: "d"

Referential boundary: The target chemical should be classified as Acylation AND Acylation >> Acylation involving an activated (glucuronidated) ester group AND Acylation >> Acylation involving an activated (glucuronidated) ester group >> Arenecarboxylic Acid Esters by Protein binding by OASIS v1.4

Domain logical expression index: "e"

Referential boundary: The target chemical should be classified as Acylation AND Acylation >> Acylation involving an activated (glucuronidated) ester group AND Acylation >> Acylation involving an activated (glucuronidated) ester group >> Arenecarboxylic Acid Esters by Protein binding by OASIS v1.4

Domain logical expression index: "f"

Referential boundary: The target chemical should be classified as Acylation >> (Tio)carbamoylation of protein nucleophiles OR Acylation >> (Tio)carbamoylation of protein nucleophiles >> Isothiocyanates, Isocyanates OR Acylation >> Acylation involving an activated (glucuronidated) carboxamide group OR Acylation >> Acylation involving an activated (glucuronidated) carboxamide group >> Carboxylic Acid Amides OR Acylation >> Direct acylation involving a leaving group OR Acylation >> Direct acylation involving a leaving group >> Carbamates  OR Acylation >> Direct acylation involving a leaving group >> Carboxylic Acid Amides OR Acylation >> Ester aminolysis OR Acylation >> Ester aminolysis >> Amides OR Acylation >> Ester aminolysis >> Dithiocarbamates OR Acylation >> Ester aminolysis or thiolysis OR Acylation >> Ester aminolysis or thiolysis >> Carbamates  OR AN2 OR AN2 >> Direct carbamoylation of protein amines OR AN2 >> Direct carbamoylation of protein amines >> Isocyanates and Diisocyanates OR AN2 >> Michael addition to activated double bonds OR AN2 >> Michael addition to activated double bonds >> alpha,beta-Unsaturated Carbonyls and Related Compounds OR AN2 >> Michael addition to alpha, beta-unsaturated acids and esters OR AN2 >> Michael addition to alpha, beta-unsaturated acids and esters >> alpha,beta-Unsaturated Carboxylic Acids and Esters OR AN2 >> Michael-type addition to quinoid structures  OR AN2 >> Michael-type addition to quinoid structures  >> Carboxylic Acid Amides OR AN2 >> Michael-type addition to quinoid structures  >> Hydroxylated Phenols OR AN2 >> Michael-type addition to quinoid structures  >> N-Substituted Aromatic Amines OR AN2 >> Michael-type addition to quinoid structures  >> Substituted Anilines OR AN2 >> Michael-type addition to quinoid structures  >> Substituted Phenols OR Michael addition OR Michael addition >> Michae addition on quinoide type compounds OR Michael addition >> Michae addition on quinoide type compounds >> Quinone methide(s)/imines; Quinoide oxime structure; Nitroquinones, Naphthoquinone(s)/imines  OR Michael addition >> Michael addition on conjugated systems with electron withdrawing group OR Michael addition >> Michael addition on conjugated systems with electron withdrawing group >> alpha,beta-Carbonyl compounds with polarized double bonds  OR No alert found OR Nucleophilic addition OR Nucleophilic addition >> Addition to carbon-hetero double bonds OR Nucleophilic addition >> Addition to carbon-hetero double bonds >> Ketones OR Radical reactions OR Radical reactions >> Free radical formation OR Radical reactions >> Free radical formation >> Hydroperoxides OR Radical reactions >> Free radical formation >> Organic peroxy compounds OR Schiff base formation OR Schiff base formation >> Direct acting Schiff base formers OR Schiff base formation >> Direct acting Schiff base formers >> 1,2-Dicarbonyls and 1,3-Dicarbonyls  OR Schiff base formation >> Schiff base formation with carbonyl compounds OR Schiff base formation >> Schiff base formation with carbonyl compounds >> Aldehydes OR Schiff base formation >> Schiff base formation with carbonyl compounds >> Aromatic carbonyl compounds OR SN2 OR SN2 >> Interchange reaction with sulphur containing compounds OR SN2 >> Interchange reaction with sulphur containing compounds >> Thiols and disulfide compounds  OR SN2 >> Nucleophilic substitution at sp3 carbon atom OR SN2 >> Nucleophilic substitution at sp3 carbon atom >> Alkyl halides  OR SN2 >> Nucleophilic substitution on benzilyc carbon atom OR SN2 >> Nucleophilic substitution on benzilyc carbon atom >> alpha-Activated benzyls  OR SN2 >> Ring opening SN2 reaction OR SN2 >> Ring opening SN2 reaction >> Epoxides, Aziridines and Sulfuranes  OR SN2 >> SN2 Reaction at a sp3 carbon atom OR SN2 >> SN2 Reaction at a sp3 carbon atom >> Activated alkyl esters and thioesters  by Protein binding by OASIS v1.4

Domain logical expression index: "g"

Referential boundary: The target chemical should be classified as (!Undefined)Group All Lipid Solubility < 0.01 g/kg AND Group C Melting Point > 55 C by Eye irritation/corrosion Exclusion rules by BfR

Domain logical expression index: "h"

Referential boundary: The target chemical should be classified as (!Undefined)Group CN Lipid Solubility < 0.4 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 All Molecular Weight > 650 g/mol OR Group C Aqueous Solubility < 0.0001 g/L OR Group C Aqueous Solubility < 0.0005 g/L OR Group C Molecular Weight > 380 g/mol OR Group CN Aqueous Solubility < 0.1 g/L OR Group CN log Kow > 4.5 OR Group CN Molecular Weight > 290 g/mol by Eye irritation/corrosion Exclusion rules by BfR

Domain logical expression index: "i"

Referential boundary: The target chemical should be classified as Non-Metals by Groups of elements

Domain logical expression index: "j"

Referential boundary: The target chemical should be classified as Halogens by Groups of elements

Domain logical expression index: "k"

Similarity boundary:Target: Oc1ccccc1C(=O)OCCc1ccccc1
Threshold=40%,
Dice(Atom centered fragments)
Atom type; Count H attached; Hybridization

Domain logical expression index: "l"

Referential boundary: The target chemical should be classified as Aromatic compound AND Carbonic acid derivative AND Carboxylic acid derivative AND Carboxylic acid ester AND Hydroxy compound AND Phenol by Organic functional groups, Norbert Haider (checkmol)

Domain logical expression index: "m"

Referential boundary: The target chemical should be classified as Dialkylether OR Ether by Organic functional groups, Norbert Haider (checkmol)

Domain logical expression index: "n"

Parametric boundary:The target chemical should have a value of log Kow which is >= 4.46

Domain logical expression index: "o"

Parametric boundary:The target chemical should have a value of log Kow which is <= 5.26

Interpretation of results:
other: not irritating
Conclusions:
The substance Phenethyl salicylate (CAS No: 87-22-9) was estimated to be not irritating into the eyes of Vienna White rabbits.Based on the estimated result Phenethyl salicylate (CAS No: 87-22-9) can be considered to be not irritating to eye.
Executive summary:

The ocular irritation potential of Phenethyl salicylate (CAS No: 87-22-9) was estimated using OECD QSAR toolbox version 3.3 with logPow as the primary descriptor. The substance Phenethyl salicylate (CAS No: 87-22-9) was estimated to be not irritating into the eyes of Vienna White rabbits.  Based on the estimated result Phenethyl salicylate (CAS No: 87-22-9) can be considered to be not irritating to eye and can be classified under the category ˋ Not Classified’ as per CLP regulation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

Various studieshas been investigated for the test chemicalPhenethyl salicylate (CAS No: 87-22-9)to observe the potential for dermal irritation to a greater or lesser extent. The studies are based on in vivo experiments in guinea pigs and humans for target chemicalPhenethyl salicylate(CAS No:87-22-9) which are summarized as follows;

 

 

The Preliminary irritation study for test chemical Phenylethyl salicylat (CAS no. 87 -22 -9) was performed on male albino Dunkin/Hartley guinea pigs to determine the concentration for suitable the sensitization study at Givuadan Roure SA Ecotoxicological Laboratory, Switzerland (SSS (Sustainability Support Services) has a letter of access,1981).In the preliminary test, the guinea pigs were treated intradermally and dermally during induction.The animals were intradermally injected with0.1ml aliquots of a range of concentration of test substance (0.25%, 0.5%, 1% or 2%)in 6% acetone/20% PEG400/0.01% Tween 80/saline.During topical application, animals received a single dermal application of 10%, 25% or 50% phenethyl salicylate in acetone using 8 mm saturated filter paper and 11 mm aluminum patch test cups which were applied to the shaved flank for 24 h. Reactions were assessed for irritation at 24 and 48 h after patch removal.The concentration which produced a definite irritation reaction is selected as the intradermal injection induction concentration. For shoulder induction, a concentration giving slight but definite irritation is selected. The highest concentration which causes no visible irritation is selected for challenge. Very slight erythema was observed at 0.25% and 0.5%. Barely perceptible erythema was observed at 10%, 25% or 50% concentrations.Since the test chemical induced cutaneous effects at concentrations 0.5% and 50%, thePhenethyl salicylate(CAS No:87-22-9) was considered to be slightly irritating while no effects were observedat concentration of 10%itwas considered to be not irritating at this concentration to the skin of male albino Dunkin/Hartley guinea pigs. Thus concentration of 0.5% was selected for the intradermal induction, a concentration of 50% phenethyl salicylate was selected for the topical induction application and10% was selected for the challenge application in sensitization study.

 

 

G. Klecak , H. Geleick , J. R. Frey (1977) andD. Belsito, D. Bickers, M. Bruze, P. Calow, H. Greim, J.M. Hanifin, A.E. Rogers, J.H. Saurat, I.G. Sipes, H. Tagami(2007) conducted two Pre-test of an OET (Open Epicutaneous Test) on Himalayan white-spotted guinea pigs for chemical Phenethyl salicylate(CAS No:87-22-9)for establishing the primary irritating threshold concentration of test material. 

In the first study, a 0.025 ml aliquot of phenethyl salicylate was applied to a 2 cm2area on the clipped flank. The application site was left uncovered and reactions were read after 24 h. It was observed that a concentration of 0.1% was the lowest concentration to produce mild irritation after a single application and was selected as the minimal irritating concentration. 

In next study, a 0.1 ml aliquot of neat phenethyl salicylate and progressively diluted solutions of phenethyl salicylate were applied to a 8 cm2area on the clipped flanks of 6–8 guinea pigs/group. The applications were repeated daily for 21 days, using the same skin site. The sites were left uncovered and the reactions were read 24 h after each application.

Minimal irritation was observed at concentration of 0.1% in both the studies .ThereforePhenethyl salicylate(CAS No:87-22-9)was considered to be irritating atconcentration of 0.03–100%onHimalayan white-spotted guinea pigs.

 

 

The last experimental study was carried out by D. Belsito, D. Bickers, M. Bruze, P. Calow, H. Greim, J.M. Hanifin, A.E. Rogers, J.H. Saurat, I.G. Sipes, H. Tagami(2007)on 5 volunteers as a part of maximization study. Phenethyl salicylate was applied at concentration of 8% to normal sites on the backs of each volunteer for 48 h under occlusive condition and later observed for skin lesions. Since none of the volunteer developed any skin reaction. The chemicalPhenethyl salicylate(CAS No:87-22-9)was considered to be not irritating on skin of five healthy volunteers.

 

 

Although no skin reactions observed in few references but on the basis of available dataand majority of results obtained in various studies, the chemicalPhenethyl salicylate(CAS No:87-22-9) can considered as slightly irritating.Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Slight Irritant”.

 

Eye irritation:

In different studies,the test chemicalPhenethyl salicylate (CAS No: 87-22-9) has been investigated for potential for ocular irritationto a greater or lesser extent. The studies are based on in vivo experiments in rabbits for target chemicalPhenethyl salicylate (CAS No: 87-22-9)its structurally similar read across substancesMethyl phenyl acetate (CAS No. – 101-41-7)and2-phenylethyl propanoate (CAS No: 122-70-3) .The predicted data using the OECD QSAR toolbox has also been compared with the experimental data and summarized as below;

The ocular irritation potential ofPhenethyl salicylate(CAS No:87-22-9) was estimated using OECD QSAR toolbox version 3.3 with logPow as the primary descriptor. The substance Phenethylsalicylate(CAS No:87-22-9) was estimated to be not irritating into the eyes of Vienna White rabbits. Based on the estimated resultPhenethyl salicylate(CAS No:87-22-9) can be considered to be not irritating to eye and can be classified under the category ˋ Not Classified’ as per CLP regulation.

 

 

This result is supported by the experimental study conducted in an OECD GLP laboratory (Sustainability Support Services (Europe) AB has the letter of access) (2014) for the structurally similar read across substance,Methyl phenyl acetate (CAS No. – 101-41-7).The study was performed as per OECD Guidelines 405 and complying to the GLP procedures. In this study, 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 as such test item was instilled in the other (treated) eye of each rabbit. The eye was observed at 1, 24, 48 and 72 hour after test item instillation. Ophthalmoscope was used for scoring of eye lesions.In the initial test, 0.1 ml of as such test item was instilled into the conjunctival sac of the right eye of animal no.1 whereas the left eye of the rabbit served as the control. As animal no. 1 showed no severe ocular lesions hence a confirmatory test was conducted on additional two rabbits (animal no. 2 and 3);0.1 ml of as such test item was instilled into the conjunctival sac of right eye of both the rabbits and left eye served as the control. Untreated eye of all the three rabbits was normal throughout the experimental period of 72 hours. The individual mean score for animal nos. 1, 2 and 3at 24, 48, 72 hours (at treated site) for corneal opacity, iris, conjunctiva and chemosis were found 0.00, 0.00, 0.33, 0.00; 0.00, 0.00, 0.33, 0.00 and 0.00, 0.00, 0.33, 0.00 respectively. Under the experimental conditions tested, eye irritation and reversibility of effects on eyes of rabbits was observed within 72 hours.  Hence under the experimental test conditions, Methyl phenyl acetate (CAS No. – 101-41-7) was considered as “Non Irritant” to New Zealand White male rabbit eyes.

 

 

The above results were further supported by the experimental study conducted by Morton Berozaa, M.N. Inscoea, , P.H. Schwartz Jr.a, M.L. Keplingera, C.W. Mastria (1975) and D. Belsito , D. Bickers , M. Bruze , P. Calow , M.L. Dagli , A.D. Fryer ,H. Greim , Y. Miyachi , J.H. Saurat , I.G. Sipes (2012) forstructurally similar read across substance2-phenylethyl propanoate (CAS No: 122-70-3) on six New Zealand albino rabbits to assess its adverse effects on eye. About 0.1ml dose of 70% 2-phenylethyl propanoate was installed into the conjunctival sac of the right eye of each of six rabbit while the left eye of each animal served as the control. Grading for eye injury was made at 1 , 24, 48 and 72 hr and at 7 days after treatment according to the grading and scoring system of Draize et al. (1944) in which a zero score indicates no irritation and the maximum score at any one scoring period is 110 (maximum irritation and damage to the cornea, iris, and conjunctiva). Slight ocular lesions were observed but all the effects were cleared within 3 days. Hence the chemical 2-phenylethyl propanoate (CAS No: 122-70-3) was considered to be not irritating to the eyes of six New Zealand albino rabbits.

 

 

Based on the available data for the target and read across substances and applying the weight of evidence approach,Phenethyl salicylate(CAS No:87-22-9) can be considered as not irritating to eyes. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Justification for classification or non-classification

The skin and eye irritation potential of test chemicalPhenethyl salicylate(CAS No:87-22-9)were observed in various studies. The results obtained from these studies indicate that the chemicalPhenethyl salicylate(CAS No:87-22-9)is likely to cause slight skin irritation but not able to causeocular lesions. HencePhenethyl salicylate(CAS No:87-22-9)can be classified under the category “Slight Irritant”for skin and“Not Classified” for eyes.