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EC number: 203-740-4 | CAS number: 110-15-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7 July - 1 December 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study according to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Bernsteinsaure = Succinic acid
- IUPAC Name:
- Bernsteinsaure = Succinic acid
- Reference substance name:
- 1,4-butane-di-carbonic-acid
- IUPAC Name:
- 1,4-butane-di-carbonic-acid
- Reference substance name:
- Succinic acid
- EC Number:
- 203-740-4
- EC Name:
- Succinic acid
- Cas Number:
- 110-15-6
- Molecular formula:
- C4H6O4
- IUPAC Name:
- succinic acid
- Details on test material:
- - Name of test material (as cited in study report):Bernsteinsaure = succinic acid
- Physical state: white crystalline powder
- Analytical purity: 99.5%
- Impurities (identity and concentrations): water
- Purity test date: no details
- Lot/batch No.: SLMB 112
- Expiration date of the lot/batch: December 1999
- Stability under test conditions: stable for duration of study
- Storage condition of test material: in refrigerator in dark
- Other: Density at 20°C = 1.56 g/cm3. pH 2.7 (1% w/v dispersion in water)
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga
- Age at study initiation: Not stated
- Weight at study initiation: 2.6, 2.8 and 2.9 kg
- Housing: Individual metal wire caging
- Diet (e.g. ad libitum): Altromin 2023 ad libitum
- Water (e.g. ad libitum): tap water via automatic watering system - ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Mean 20°C
- Humidity (%): average of 71 %
- Air changes (per hr): 12/h
- Photoperiod (hrs dark / hrs light): 12/12
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): 0.5 g applied to a 25 x 25 mm area moistened with 1.0 mL of deionised water
- Concentration (if solution): Not applicable - Duration of treatment / exposure:
- 4 h
- Observation period:
- Rabbits observed at 1, 24, 48 and 72 hours after dressing removal. termination on Day 4
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 25 x 25 mm
- % coverage: not applicable
- Type of wrap if used: cellulose patch, covered by non-irritating tape (Blenderm) and covered by self adhesive nonwoven fabric hypoallergenic dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual material wiped off with wet tissue
SCORING SYSTEM: Standard Draize skin assessment
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No reactions observed
- Remarks on result:
- other: No erythematous response apparent at any time point for any rabbit
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No reactions observed
- Irritant / corrosive response data:
- Erythema mean score for 24-72 hours = 0
Oedema mean score for 24-72 hours = 0 - Other effects:
- None
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No reactions were observed. The mean scores for erythema and oedema were zero. No classification is required for succinic acid in respect of skin irritation in accordance with Directive 67/548/EEC as amended or the Classification Regulation 1272/2008
- Executive summary:
A skin irritation assessment was completed in accordance with standard OECD and EU test methods (Method 404 or B.4). Three female rabbits were exposed to succinic acid for 4 hours.
No reactions were observed. The mean scores for erythema and oedema were zero. No classification is required for succinic acid in respect of skin irritation in accordance with Directive 67/548/EEC as amended or the Classification Regulation 1272/2008.
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