Benzyl benzoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 to 18 March 1982

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

six rabbits used rather than three, but this does not affect validity of results

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Benzyl benzoate

EC Number:

204-402-9

EC Name:

Benzyl benzoate

Cas Number:

120-51-4

Molecular formula:

C14H12O2

IUPAC Name:

benzyl benzoate

Test material form:

other: clear liquid

Details on test material:

- Name of test material (as cited in study report): 81-223-02 (benzyl benzoate)

- Physical state: clear liquid
- Analytical purity: no data

- Lot/batch No.: no data

- Stability under test conditions: stable for duration of test, no change in physical appearance noted
- Storage condition of test material: no data

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hilltop Lab Animals Scottdale, Pennsylvania
- Age at study initiation: no information
- Weight at study initiation: 2.07 to -2.28 kg (males - 2.066, 2.279 and 2.158 kg; females - 2.144, 2.261 and 2.247 kg)
- Housing: individually in laboratory standard cages
- Diet (e.g. ad libitum): Wayne Rabbit Ration ad libitum
- Water (e.g. ad libitum): Potable tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%):30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 11 March 1982 To: 18 March 1982

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated contralateral eye used as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted, as supplied

Duration of treatment / exposure:

single instillation

Observation period (in vivo):

7 days, treated eyes assessed on day 1, 2, 3, 4 and 8 at 1, 24, 48, and 72 hours post instillation and again after 7 days

Number of animals or in vitro replicates:

6, three males, three females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No reported flushing the treated eyes
- Time after start of exposure: not applicable

SCORING SYSTEM: standard Draize assesment

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein -- no details reported

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

20

Reversibility:

fully reversible within: 24 hours

Results 2

Irritation parameter:

conjunctivae score

Time point:

24/48/72 h

Score:

0

Max. score:

20

Reversibility:

fully reversible within: 24 hours

Results 3

Irritation parameter:

iris score

Time point:

24/48/72 h

Score:

0

Max. score:

10

Reversibility:

fully reversible within: 24 hours

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

80

Reversibility:

other: no effects observed

Results 5

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: one hour post instillation

Score:

0

Max. score:

80

Reversibility:

other: no effects observed

Remarks on result:

other: No corneal changes noted in six rabbits

Results 6

Irritation parameter:

iris score

Basis:

mean

Time point:

other: one hour post instillation

Score:

0.83

Max. score:

10

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: only one treated eye showed iridial reaction

Results 7

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: one hour after instillation

Score:

2.67

Max. score:

20

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: six rabbits showed slight conjunctival reddening, no chemosis apparent in any treated eyes

Irritant / corrosive response data:

Slight or diffuse conjunctival injection apparent for all six rabbits within an hour of benzyl benzoate instillation. A minimal iridial response was also seen in one treated eye at this assessment. All reactions had resolved within 24 hours of dosing and the eyes were overtly normal for the remainder of the observation period (up to Day 8).

Other effects:

None observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on only very slight reactions being noted one hour after dosing, all of which had resolved wih in 24 hours, benzyl benzoate was not considered to be irritating to rabbit eyes.

Executive summary:

Six rabbits were allocated to the study based on a negative response to examination using sodium fluorescein stain 24 hours before dosing, which confirmed no pre-existing ocular damage was present. The right eye in each case was treated with 0.1 ml of undiluted benzyl benzote, instilled into the lower conjunctival sac on day 1. The left eye was used as an untreated control for each rabbit.

Eyes were examined 1, 24, 48 and 72 hours after dosing and again on day 8 (7 days after dosing). The assessment of ocular change was made using the standard Draize scoring scheme.

All six treated eyes developed a low degree of conjuctival vaculature injection within an hour of dosing but this resolved in all animals within 24 hours. A slight iridial response apparent in one rabbit also resolved by day 2.

The mean scores for 24, 48 and 72 hour assessments were all zero and consequently benzyl benzoate is not considered to be an ocular irritant. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.