Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
