Phenethyl pivalate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted similarly to OECD Guideline 405 with deviations: no data about purity and no certificate of analysis of the test substance; no details on environmental conditions; age of animals at the start of study not reported

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

no data about purity and no certificate of analysis of the test substance; no details on environmental conditions; age of animals at the start of study not reported

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Remarks:

pre-GLP

Test material

Test material information

Constituent 1

Reference substance name:

Phenethyl pivalate

EC Number:

266-841-2

EC Name:

Phenethyl pivalate

Cas Number:

67662-96-8

Molecular formula:

C13H18O2

IUPAC Name:

2-phenylethyl 2,2-dimethylpropanoate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Fenethylpivalinate
- Physical state: Clear colourless liquid
- Date received: 20 March 1980

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

- Housing: Animals were housed individually in cages.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Undiluted

Duration of treatment / exposure:

24 h

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

Six

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: Eyes were not washed following instillation and the animals were released immediately.

SCORING SYSTEM: Ocular lesions were scored at 24, 48 and 72 h after instillation according to a scale comparable to the OECD Guideline 405.

TOOL USED TO ASSESS SCORE: Ocular reactions were read using a binocular magnifying glass. The diagnosis of corneal damage was confirmed, if necessary, by staining the eyes of the animals with fluorescein-impregnated papers. After flushing the excess fluorescein solution, the eyes were examined in a dark room under UV illumination.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: average of 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: average of 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: average of 24, 48 and 72 h

Score:

0.28

Max. score:

3

Reversibility:

fully reversible within: 3 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: average of 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

- Slight redness of the conjunctivae was noted in 4/6 rabbits.
- After three days, these lesions had cleared up completely.

Other effects:

None

Any other information on results incl. tables

Table 7.3.2/1: Scores for ocular lesions

Animal no.	Cornea				Iris				Conjunctivae redness				Conjunctivae chemosis
	24 h	48 h	72 h	Mean*	24 h	48 h	72 h	Mean*	24 h	48 h	72 h	Mean*	24 h	48 h	72 h	Mean*
1	0	0	0	0	0	0	0	0	0	0	0	0.00	0	0	0	0
2	0	0	0	0	0	0	0	0	1	0	0	0.33	0	0	0	0
3	0	0	0	0	0	0	0	0	1	0	0	0.33	0	0	0	0
4	0	0	0	0	0	0	0	0	0	0	0	0.00	0	0	0	0
5	0	0	0	0	0	0	0	0	1	1	0	0.67	0	0	0	0
6	0	0	0	0	0	0	0	0	1	0	0	0.33	0	0	0	0
Mean^#				0				0				0.28				0

*mean of scores at 24, 48 and 72 h

^#mean of scores of all 6 animals

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, fenethylpivalinate is not classified as irritating to eyes according to the Annex VI of the Directive 67/548/EEC and of the Regulation (EC) N° 1272-2008 (CLP).

Executive summary:

In an eye irritation study conducted similarly to the OECD Guideline 405, six rabbits of the New Zealand White strain were exposed to 0.1 mL of fenethylpivalinate in one eye, while the other eye remained untreated and served as control. The eyelids were then gently held together for 1 second to avoid any loss of the test material. Eyes were not washed and ocular reactions were read at 24, 48 and 72 h following instillation using a binocular magnifying glass. The diagnosis of corneal damage was confirmed, if necessary, by staining the eyes of the animals with fluorescein-impregnated papers. After flushing the excess fluorescein solution, the eyes were examined in a dark room under UV illumination. Ocular reactions were graded according to a scale comparable to the OECD Guideline 405.

Slight redness of the conjunctivae was noted in 4/6 rabbits. After three days, these lesions had cleared up completely. The calculated mean scores for each individual lesion for all animals within three scoring times (24, 48 and 72 h) were as follows: 0.00 for cornea score; 0.00 for iris score; 0.28 for conjunctivae score and 0.00 for chemosis score. In this study, fenethylpivalinate is not an eye irritant on rabbits.

Under the test conditions, fenethylpivalinate is not classified as irritating to eyes according to the Annex VI of the Directive 67/548/EEC and of the Regulation (EC) N° 1272-2008 (CLP).