Registration Dossier

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The restriction is due to the use of the read across approach: the test was performed not with 3-PPB but with Benzyl benzoate, a substance which has been demonstrated to be very similar in structure, physical/chemical properties and toxicological profile.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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

Reference
Name:
Unnamed
Type:
Constituent
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

Resultsopen allclose all
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
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
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: one hour post 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).

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.