Phenethyl isovalerate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Phenethyl phenylacetate

EC Number:

203-013-1

EC Name:

Phenethyl phenylacetate

Cas Number:

102-20-5

Molecular formula:

C16H16O2

IUPAC Name:

2-phenylethyl phenylacetate

Details on test material:

- Name of test material : phenethyl phenylacetate- Substance type: organic- Physical state: Liquid-SMILES:c1(CC(=O)OCCc2ccccc2)ccccc1

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Age : 10 to 12 weeksSex : FemaleBody weight range : 2.0 kg ±200gNo. of animals: Three Acclimatization:The rabbit was acclimatized to standard laboratory condition for 24 hours in experimental room before study.Environmental conditions : Air conditioned room with 10-15 air changes per hour, temperature between 22-250C, relative humidity 40-60% and illumination cycle set to 12 hours artificial fluorescent light and 12 hours dark.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

0.1 ml

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

No. of animals : Three

Details on study design:

The test compound Phenethyl phenylacetate was applied in the amount of 0.1 ml in the conjunctival sac of rabbit after gently pulling the lower lid away from the eyeball. The other eye which remain untreated, served as a control. The acute irritation to eye conjunctiva, cornea and iris was evaluated at 1, 24, 48 and 72 hours after the treatment. The grades of ocular reaction (conjunctiva, cornea and iris) were recorded at each observation. To determine the reversibility of the effect the animals were observed normally for 21 days. Any other lesions in the eye viz pannus, staining were observed and scored accordingly. Examination of reactions was facilitated by use of biomicroscope and hand slit lamp. Individual animal weight before and during the study was observed.

Results and discussion

In vivo

Results

Irritation parameter:

other: MMAS ( Modified Maximum Average Draizes test )

Basis:

mean

Score:

0

Reversibility:

not specified

Remarks on result:

other: In the dose levels used in the study, no eye irritation symptoms were observed in rabbit

Irritant / corrosive response data:

The test compound Phenethyl phenylacetate when applied to the eye of New Zealand white rabbit at the dose level of 0.1 ml did not produced any lesions such as pannus, staining throughout the observation period of 72 hours as well as the entire observation period (21 days).

Other effects:

The test compound Phenethyl phenylacetate applied in conjunctival sac of rabbits did not show any observable clinical signs throughout the observation period of 21 days.

Any other information on results incl. tables

GRADING OF OCULAR LESIONS

 

S.NO/ SEX		OBSERVATION	Score				Total	Total Score
1/F			1 hour	24hours	48 hours	72 hours
	Cornea	A.       Opacity-Degree of Density	0	0	0	0	0	0×0×5=0
		B.       Area of Cornea Involved	0	0	0	0	0
	Iris	A.       Values	0	0	0	0	0	0
	Conjunctivae	A.       Redness	0	0	0	0	0	0+0+0×5=00
		B.       Chemosis	0	0	0	0	0
		C.       Discharge	0	0	0	0	0
2/F	Cornea	A.       Opacity-Degree of Density	0	0	0	0	0	0×0×5=0
		B.       Area of Cornea Involved	0	0	0	0	0
	Iris	A.       Values	0	0	0	0	0	0
	Conjunctivae	A.       Redness	0	0	0	0	0	0+0+0×5=00
		B.       Chemosis	0	0	0	0	0
		C.       Discharge	0	0	0	0	0
3/F	Cornea	A.       Opacity-Degree of Density	0	0	0	0	0	0×0×5=0
		B.       Area of Cornea Involved	0	0	0	0	0
	Iris	A.       Values	0	0	0	0	0	0
	Conjunctivae	A.       Redness	0	0	0	0	0	0+0+0×5=00
		B.       Chemosis	0	0	0	0	0
		C.       Discharge	0	0	0	0	0
Grand total								00
Mean								0.00
Eye Irritation Scoring index								0.00

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

The MMAS ( Modified Maximum Average Draizes test ) score of Phenethyl phenylacetate in New Zealand white rabbits was calculated to be 0 from the test result using OECD method. From this, it is concluded that the test substance Phenethyl phenylacetate can be classified under non irritant categories at the dose level of 0.1 ml.

Executive summary:

The MMAS ( Modified Maximum Average Draizes test ) score of Phenethyl phenylacetate in New Zealand white rabbits was calculated to be 0. From this it is concluded that the test substance Phenethyl phenylacetate can be classified under non irritant categories at the dose level of 0.1 ml.