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EC number: 208-534-8 | CAS number: 532-32-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 03 to 06 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, West-Germany
- Age at study initiation: ±12 weeks
- Weight at study initiation: 2462-3094 gram
- Housing: Individually in cages with perforated floors equipped with an automatic drinking system
- Diet (e.g. ad libitum): Standard laboratory rabbit diet approx. 100 gram 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
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±3℃
- Humidity (%): 30-70%
- 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
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
- Concentration (if solution): - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: Approximately 100 square centimeters (10 cm×10 cm)
- % coverage:
- Type of wrap if used: elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: One of three animals appeared very slight erythema.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- The test substance resulted in a primary irritation index of 0 (non-irritation) when applied to intact rabbit skin.
The observed skin irritation consisted of very slight erythema in one animal. The irritation was reversible within 24 hours after exposure.
No corrosive effect was evident on the skin. - Other effects:
- No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Any other information on results incl. tables
Individual skin irritation scores
Time after exposure |
Rabbit 2735 |
Rabbit 2736 |
Rabbit 2737 |
|||
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
|
1 hour 24 hours 48 hours 72 hours |
0 0 0 0 |
0 0 0 0 |
1 0 0 0 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is not irritating when applied to the intact rabbit skin.
- Executive summary:
This study was conducted under GLP according to OECD 404. Three rabbits were exposed to 0.5 g of the test substance, moistened with water, by application onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were assessed at 1, 24, 48 and 72 hours after the removal of the dressings and test article.
Under the conditions of this study, the test substance resulted in a primary irritation index of 0 when applied to the intact rabbit skin. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. In conclusion, the test substance is not irritating when applied to the intact rabbit skin.
The study represents a worst case situation as the treated skin area was 100 cm2 instead of 6 cm2 as required by the present version of OECD 404.
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