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EC number: 253-452-8 | CAS number: 37294-49-8
- 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 (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 Oct 2014 to 05 Dec 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- May 2008, including most recent amendments
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- March 2003
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000; including the most recent partial revisions
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Sulfosuccinates may cause false positive/negative results in the LLNA, therefore the GPMT is a golden standard test for these compounds.
Test material
- Reference substance name:
- Disodium C-isodecyl sulphonatosuccinate
- EC Number:
- 253-452-8
- EC Name:
- Disodium C-isodecyl sulphonatosuccinate
- Cas Number:
- 37294-49-8
- Molecular formula:
- C14H26O7S.2Na
- IUPAC Name:
- disodium 4-[(2-methylnonyl)oxy]-4-oxo-3-sulfonatobutanoate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Disodium isodecyl sulfosuccinate
- Substance type: organic
- Physical state: white powder
- Storage condition of test material: At room temperature in a well-sealed container
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River France, L’Arbresle Cedex, France
- Age at study initiation: approx. 4-8 weeks old
- Weight at study initiation: 361-477 g
- Housing: Group housing of maximally 5 animals per cage
- Diet: Complete maintenance diet for guinea pigs (SSNIFF® Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: Free access to tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 40-70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From 21 Oct 2014 To 05 Dec 2014
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- Preliminary test:
Intradermal injection: 40%, 20%, 10%, 5%, 2%, 1%, 0.5%, 0.2%.
Epidermal exposure: 40%, 20%, 10%, 5%.
Main study:
Intradermal injection: 0.5%
Epidermal application: 10%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Preliminary test:
Intradermal injection: 40%, 20%, 10%, 5%, 2%, 1%, 0.5%, 0.2%.
Epidermal exposure: 40%, 20%, 10%, 5%.
Main study:
Intradermal injection: 0.5%
Epidermal application: 10%
- No. of animals per dose:
- 10 (test group)
5 (control group) - Details on study design:
- RANGE FINDING TESTS:
For the intradermal injections a series of four test substance concentrations was tested; the highest concentration was the maximum concentration that could technically be injected. Two animals received two different concentrations in duplicate (0.1 mL/ site) in the clipped scapular region. The resulting dermal reactions were assessed 24 and 48 hours after treatment. Based on the results in the initially treated animals, two additional animals were treated in a similar manner with four lower concentrations at a later stage.
For the epidermal application, a series of four test substance concentrations was tested, the highest concentration being the maximum concentration that could technically be applied. Two different concentrations were applied (0.5 mL each) per animal semi-occlusively to the clipped flank (site of 2x3cm). The animals receiving intradermal injections were treated with the lowest concentrations and two other animals with the highest concentrations. After 24 hours, the dressing was removed and the skin cleaned of residual test substance using water. The treated skin areas were assessed for irritation 24 and 48 hours after exposure.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: one intradermal injection on day 1; epidermal application on day 8
- Exposure period (epidermal application): 24 hours
- Test group: 10 animals
- Control group:5 animals
- Site: scapular area
- Concentrations: 0.5% (intradermal injection), 10% (epidermal application)
B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day of challenge:day 22
- Exposure period: 24 hours
- Test groups: 10% test substance
- Control group: vehicle only
- Site: flank
- Evaluation (hr after challenge): at 24 and 48 hours after removal of the dressing - Challenge controls:
- Historical control data are provided.
- Positive control substance(s):
- yes
- Remarks:
- Alpha- hexylcinnamaldehyde
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 20% Alpha- hexylcinnamaldehyde
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- The skin reactions observed in nine experimental animals in response to the 20% test substance concentration in the challenge phase were considered indicative of sensitisation, based on the absence of any response in the control animals.
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- 90% sensitisation rate in reliability check performed in July/August 2014
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 20% Alpha- hexylcinnamaldehyde
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- The skin reactions observed in nine experimental animals in response to the 20% test substance concentration in the challenge phase were considered indicative of sensitisation, based on the absence of any response in the control animals.
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- 90% sensitisation rate in reliability check performed in July/August 2014
Any other information on results incl. tables
No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.
On day 3 after intradermal injection of 1:1 Mixture of FCA and water (and a 1:1 Mixture of FCA and vehicle for injection), all animals had erythema grade 3. One control animal had slight erythema (grade 1) related to injection of vehicle. This reaction was also found in 6 guinea pigs of the test group after injection with 0.5% test substance. Additionally, one animal in the test group had well-defined erythema (grade 2). One animal from the test group had signs of necrosis (1 mm in diameter). Signs of necrosis were seen in all animals of the test group at the injection site of 1:1 Mixture of FCA and a 20% test substance concentration (size ranging form 3 to 5 mm, on average 3.8 mm); No skin reaction was seen after epidermal exposure to the vehicle or to 10% test substance in any of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of a guinea pig maximisation test, performed according to OECD/EC guidelines and GLP principles, disodium isodecyl sulfosuccinate was found to be not sensitising.
- Executive summary:
A guinea pig maximisation test was performed with disodium isodecyl sulfosuccinate according to OECD/EC guidelines and GLP principles. Reliable positive and negative controls were included. Based on a preliminary irritation study, the test substance concentrations selected for the main study were a 0.5% concentration for the intradermal induction and a 10% concentration for the epidermal induction exposure. A 10% test substance concentration was selected for the challenge phase. During the main study, no mortality occurred and no symptoms of systemic toxicity were observed. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period. Epidermal exposure to the vehicle or to 10% test substance did not result in a skin reaction in any of the animals. Since no responses were observed in the experimental animals in response to a 10% test substance concentration in the challenge phase, it is concluded that disodium isodecyl sulfosuccinate has no sensitising properties according to CLP Regulation (EC) No. 1272/2008.
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