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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

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:
1999
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

Constituent 1
Reference substance name:
Bernsteinsaure = Succinic acid
IUPAC Name:
Bernsteinsaure = Succinic acid
Constituent 2
Reference substance name:
1,4-butane-di-carbonic-acid
IUPAC Name:
1,4-butane-di-carbonic-acid
Constituent 3
Chemical structure
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)

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.