Benzoic acid, 4-[(1-oxodecyl)oxy]-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well performed GLP and OECD guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Benzoic acid, 4-[ (1-oxodecyl) oxy]-

EC Number:

617-941-3

Cas Number:

86960-46-5

Molecular formula:

C17H24O4;

IUPAC Name:

Benzoic acid, 4-[ (1-oxodecyl) oxy]-

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan Netherlands BV, Kreuzelweg 53, NL-5961 NM Horst / The Netherlands
- Age at study initiation: 13 weeks (male), 10 weeks (females)
- Weight at study initiation: 2594, 2158, 2158 grams
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks and haysticks were provided for gnawing.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet, ad libitum
- Water (e.g. ad libitum): Community tap water, ad libitum.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): light cycle of 12 hours light and 12 hours dark

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The right eye remained untreated and served as the reference control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g (per animal)
- Concentration (if solution): undiluted

VEHICLE
- no vehicle used

Duration of treatment / exposure:

single application (conjunctival sac of the left eye) without rinsing

Observation period (in vivo):

The eyes of each animal were examined approximately 1, 24, 48, 72 hours , as well as 7 days after administration.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eyes were not rinsed

SCORING SYSTEM: according to the numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004

TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp (Roth AG, CH-4153 Reinach/Switzerland)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: # 1, 2, 3 each

Time point:

other: mean of 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: initial slight signs of irritation were fully reversible within 24h

Results 2

Irritation parameter:

iris score

Basis:

animal: # 1, 2, 3 each

Time point:

other: mean of 24, 48, 72 h

Score:

0

Max. score:

2

Reversibility:

other: no signs of irritation (iris) at any time

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal: # 1, 3 each

Time point:

other: mean of 24, 48, 72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

other: mean of 24, 48, 72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

conjunctivae score

Remarks:

chemosis

Basis:

animal: # 1, 2, 3 each

Time point:

other: mean of 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: no signs of irritation (chemosis) at any time

Irritant / corrosive response data:

The instillation resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis. These effects were reversible and were no longer evident 7 days after treatment. A slight reversible corneal opacity was noted in one animal at the 1-hour reading. No abnormal findings were observed in the iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed.

Other effects:

No clinical signs were observed

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based upon the referred classification criteria, the test item is considered to be "not irritating" to the rabbit eye.

Executive summary:

The primary eye irritation potential of the test item was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1 g into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7 days after test item instillation. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately.

The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 1.00, 1.33 and 1.00 for reddening, respectively, and 0.00 for chemosis for each of the three animals. The instillation of the test item into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis. These effects were reversible and were no longer evident 7 days after treatment, the end of the observation period for all animals. A slight reversible corneal opacity was noted in one animal at the 1-hour reading. No abnormal findings were observed in the iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed and no clinical signs were observed.

Thus, the test item did not induce significant or irreversible damage to the rabbit eye.