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EC number: 208-534-8 | CAS number: 532-32-1
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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- Toxicological Summary
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- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

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:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- GLP compliance:
- yes
Test material
- 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
- Reference substance name:
- Benzoic acid, sodium salt
- IUPAC Name:
- Benzoic acid, sodium salt
- Details on test material:
- Batch No.: Not specified
Purity: ≥99.5%
Constituent 1
Constituent 2
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
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- 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
- 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.
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