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EC number: 236-164-7 | CAS number: 13197-76-7
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 May 1995 to 31 July 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dodecyl(2-hydroxy-3-sulphonatopropyl)dimethylammonium
- EC Number:
- 236-164-7
- EC Name:
- Dodecyl(2-hydroxy-3-sulphonatopropyl)dimethylammonium
- Cas Number:
- 13197-76-7
- Molecular formula:
- C17H37NO4S
- IUPAC Name:
- dodecyl(2-hydroxy-3-sulphonatopropyl)dimethylammonium
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Betadet S-20
Lot number: 7244
Appearance: transparent viscous liquid
pH: 7.49
Stored: Room temperature, protected from light.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Three New Zealand White male rabbits were used.
Weight on receipt: 2.1-2.2 kg
Age on receipt: approximately 9-11 weeks
Source: Accredited supplier
Housing: Individually in stainless steel cages with a grill floor
Acclimatisation period: at least seven days
Weight at administration of test substance: 2.3-2.8 kg
Temperature: 17-22 degrees C
Humidity: 50-90%
Photoperiod: 12 dark/light cycle
Diet: Standard rabbit diet UAR 112, supplied by PANLAB, S. L., ad libitum
Water: Supplied by Compañia de Aguas de Sabadell, ad libitum
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- Four hours
- Observation period:
- The reaction of the test zone was evaluated approximately 30-60 minutes and 24, 48 and 72 hours after the end of the exposure period. Additional observations were carried out after seven days to check the reversibility of the observed reactions.
- Number of animals:
- Three
- Details on study design:
- Animals were shaved approximately 24 hours before administration using an electric razor, leaving the back and sides exposed from the scapula to the pelvis.
One square test zone, measuring approximately 6 square centimetres was delimited on the shaved intact skin of one side of the animals.
The test substance was applied in a single dose of 0.5 mL. The substance was placed on 2.5 x 2.5 cm squares of hydrophilic gauze and applied to the corresponding test area. The resulting patches were held in place with strips of adhesive tape. A strip of gauze was wrapped around the trunk of the animals using adhesive tape to hold the patches in place.
The animals were observed following administration before being returned to their cages.
After a 4-hour period, the patches were removed and the remainder of the product eliminated with water.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.78
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Scores for irritation
|
60 minutes |
24 hours |
48 hours |
72 hours |
Mean (24-72 hours) |
7 days |
Erythema |
1,1,1 |
1,1,1 |
0,1,1 |
0,1,1 |
0.78 |
0,0,0 |
Oedema |
0,0,0 |
0,0,0 |
0,0,0 |
0,0,0 |
0.00 |
0,0,0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Minimal transient irritation was observed in this study; the substance does not require classification according to CLP criteria.
- Executive summary:
A skin irritation study was conducted with Betadet S-20 according to OECD Test Guideline 404. The test material was applied to the skin of 3 rabbits (0.5 mL) for 4 hours. The animals were observed for 7 days. The treatment sites were assessed after 1, 24, 48 and 72 hours. The sites were assessed after 7 days to determine reversibility. One hour after patch removal, slight edema (Grade 1) was noted for all 3 animals. The mean effect scores over time of 24, 48 and 72 hours were 0.78 for erythema and 0.0 for oedema. The effects were fully reversible within 7 days. Minimal transient irritation was observed in this study; the substance does not require classification according to CLP criteria.
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