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EC number: 205-503-0 | CAS number: 141-82-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Justification for type of information:
- Succinic acid may be used as an analogue for malonic acid, based on the following considerations. Firstly, dicarboxylic acids are naturally occurring metabolic products of fatty acid oxidation, and are rapidly beta-oxidised. A category approach for short-medium chain dicarboxylic acids, including malonic acid and succinic acid, has been validated and used by various bodies including the Cosmetics Ingredient Review Panel and the European Food Safety Authority.The study was carried out to provide a comparison between the LLNA and GPMT tests, rather than to investigate the properties of the test materials, nevertheless it follows standard OECD guidelines and was carried out in accordance with GLP.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- not specified
- Remarks:
- GLP claimed, but validation not seen
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- 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
Constituent 1
- Specific details on test material used for the study:
- Succinic acid (Aldrich No. 398055), purity 99%, was obtained from Sigma-Aldrich (Munich, Germany)
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: SPF-CBA/Ca01aHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- Female SPF-CBA/Ca01aHsd mice (6–12 weeks) were purchased from Harlan Winkelmann (Borchen, Germany). The mice were housed in groups in Macrolon cages on Altromin saw fiber bedding. The animals were barrier-maintained (semi-barrier) in an air conditioned room (temperature 22 ± 3 °C, relative humidity 55 ± 10%) with a 12-h light/dark cycle and air change rate of at least 10/h. The acclimatization period was at least five days. Food (Altromin 1324 maintenance diet for rats and mice, totally-pathogen-free and tap water were provided ad libitum.
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 5%, 10%, 25%
- No. of animals per dose:
- 5
- Details on study design:
- A preliminary experiment was performed with three animals to detect the highest tolerable exposure concentration. Three different concentrations of the test compound were applied daily to the ears of the animals, which were observed for systemic effects and local skin irritation. Local irritant effects expressed as ear swelling were assessed by measuring the ear thickness on day 1 and day 4.In the main test, groups of 5 mice were treated by topical applications of 25 ll test or control solution to the entire dorsal surface of each ear. Topical applications were performed once daily over three consecutive days. A negative control group was treated with the vehicle alone. The positive control group received p-phenylenediamine at 1% in the respective vehicle. On day 6, all mice were dosed with 20 lCi 3H-methyl thymidine by intravenous injection into the tail vein. Approximately 5 h after 3H-methyl thymidine injection, all mice were sacrificed. The draining auricular lymph nodes were excised, weighed (the left and right lymph nodes were weighed and the mean calculated for each mouse), individually pooled for each animal (two lymph nodes per animal) and collected in PBS.Cell suspensions were prepared and tritated thymidine was measured using a scintillation counter and expressed as disintegrations per minute.The proliferative response of the lymph node cells was expressed as number of disintegrations per node (DPM/node) adjusted for background values. The Stimulation Index was calculated as the ratio of the arithmetic mean of DPM/node values for the test and control groups.In addition to the requirements of the OECD guideline, a lymph node weight index (LNWI) was calculated as the ratio of the arithmetic mean lymph node weight values of the test group and the negative control group.
- Positive control substance(s):
- other: p-phenylenediamine at 1%
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.3
- Test group / Remarks:
- 25% concentration
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- 10% concentration
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- 5% concentration
Any other information on results incl. tables
Succinic acid gave clearly negative results, i.e. SI values were below 3 for all tested concentrations. As the lymph node weight reaction was weak and lacked a dose–response relationship, the SI result was given precedence. Therefore, succinic acid was considered to show no skin sensitizing potential in the LLNA.
Stimulation indices (SI) ± SD and lymph node weight indices (LNWI) ± SD obtained in the LLNA
Test substance |
Vehicle Parameter |
Index ± SD at test concentration |
||
25% |
10% |
5% |
||
Succinic acid |
DMSO SI |
1.3 ± 0.7 |
1.2 ± 0.3 |
1.2 ± 0.4 |
LNWI |
1.1 ± 0.1 |
1.1 ± 0.1 |
1.12 ± 0.03 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Succinic acid gave clearly negative results in the mouse LLNA test, i.e. SI values were below 3 for all tested concentrations. As the lymph node weight reaction was weak and lacked a dose–response relationship, the SI result was given precedence. Therefore, succinic acid was considered to show no skin sensitizing potential in the LLNA.
- Executive summary:
The skin sensitization potential of eight unsaturated and one saturated lipid (bio)chemicals was tested in both the LLNA and the GPMT to address the hypothesis that chemicals with unsaturated carbon–carbon double bonds may result in a higher number of unspecific (false positive) results in the LLNA compared to the GPMT. In this test series, succinic acid gave clearly negative results (SI <3) and was not considered sensitising.
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