Sodium benzoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 10 to 24 May 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium benzoate

EC Number:

208-534-8

EC Name:

Sodium benzoate

Cas Number:

532-32-1

Molecular formula:

C7H6O2.Na

IUPAC Name:

sodium benzoate

Constituent 2

Reference substance name:

Benzoic acid, sodium salt

IUPAC Name:

Benzoic acid, sodium salt

Details on test material:

Batch No.: Not specified
Purity: ≥99.5%

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Animal 2711 from Broekman Institute, Someren, The Netherlands. Animals 2717 and 2737 from Charles River Wiga, Sulzfeld, West-Germany.
- Age at study initiation: Approx. 12-14 weeks
- Weight at study initiation: 2654-3179 grams
- Housing: Individually in cages with perforated floors and equipped with an automatic drinking system.
- Diet (e.g. ad libitum): Pelleted standard rabbit maintenance diet approx. 100 g per day.
- Water (e.g. ad libitum): Free access to tap-water diluted with decalcified water.
- Acclimation period: At least five days under test conditions for animal 2711, four days for animal 2737 and two days for animal 2717.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±3℃
- Humidity (%): 30-83%
- Air changes (per hr): 7.5-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light / 12 hours dark

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ±60 mg

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

14 days

Number of animals or in vitro replicates:

3 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: Draize scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 24 hours

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 2.44

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0.67

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

The test substance appeared to be mildly irritating (M2) to the rabbit eye (Kay and Calandra interpretation of the Draize score: 9.3).

Instillation of the substance into one of the eyes of each of three albino rabbits affected the conjunctivae. The irritation of the conjunctivae was reversible within 14 days.

Treatment of the eyes with fluorescein 2%, 24 hours after test article instillation revealed no corneal epithelial damage in any of the animals.

No corrosion was observed.

Other effects:

No staining by the test article was observed.
No toxic symptoms were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Individual eye irritation scores

Animal	Time after application	Cornea opacity	Iris	Conjunctivae
				Redness	Chemosis
2711	1 hour 24 hours 48 hours 72 hours 7 days 14 days	0 0 0 0 0 0	1 0 0 0 0 0	1 2 3 3 2 0	1 1 1 0 0 0
2717	1 hour 24 hours 48 hours 72 hours 7 days 14 days	0 0 0 0 0 0	0 0 0 0 0 0	2 2 3 3 2 0	2 1 1 0 0 0
2737	1 hour 24 hours 48 hours 72 hours 7 days 14 days	0 0 0 0 0 0	0 0 0 0 0 0	1 2 2 2 1 0	1 1 1 0 0 0

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance is mildly irritating to the rabbit eye, sufficient to warrant classification as Category 2 (Reversible eye effects).

Executive summary:

This study was conducted under GLP according to OECD 405. Three rabbits were exposed to 60 mg of the test substance, by instilling the test substance into the eye. The eyes of each animal were examined approx. 1, 24 ,48 and 72 hours, and 7 and 14 days after instillation of the test article.

Under the conditions of this study, the test substance resulted in adverse effects on the conjunctivae. The irritation of the conjunctivae was reversible within 14 days. No corrosion nor signs of systemic intoxication were observed. The test article should be considered mildly irritating to the rabbit eye.