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EC number: 269-225-1 | CAS number: 68201-55-8
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1982-11-24 - 1982-12-13 (experimental phase)
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted May 12, 1981
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- FDA principles
Test material
- Reference substance name:
- Betaines, coco alkyldimethyl(3-sulfopropyl)
- EC Number:
- 269-225-1
- EC Name:
- Betaines, coco alkyldimethyl(3-sulfopropyl)
- Cas Number:
- 68201-55-8
- Molecular formula:
- C7H17NO3S·[CH2]6-16
- IUPAC Name:
- [3-(dodecyldimethylazaniumyl)propyl]trioxo-λ⁶-sulfanuide
- Test material form:
- liquid
- Remarks:
- clear
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, 4414 Fuellinsdorf, Switzerland
- Age at study initiation: approx. 12 weeks
- Weight at study initiation: 2.3 - 3.0 kg
- Housing: Caged individually in stainless steel cages with automatic drinking water supply and cleaning system (Dipl. Ing. W. Ehret GmbH, Versuchstiertechnik, 7830 Emmendingen, Germany)
- Diet (e.g. ad libitum): Pelleted standard Kliba 23/341/1 rabbit maintenance diet (Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland) defined for acceptable contaminant level, ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2°C
- Humidity (%): 55±10%
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1982-11-24 To: 1982-12-13
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- single application, no wash-out
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3 animals (2 males, 1 female)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM: Draize JH, 1959
TOOL USED TO ASSESS SCORE: none stated
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Remarks:
- Primary Eye Irritation Index
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 25.3
- Remarks on result:
- probability of mild irritation
- Remarks:
- slight irritation
- Irritant / corrosive response data:
- The test item showed a slight irritation when applied on the rabbit eye mucosa. No discoloration of the cornea and conjunctivae was observed (score: zero) in the rabbits during the entire test period which could be related to effects of the test material. No corrosion effect was observed at each of the measuring intervals.
- Other effects:
- - Other adverse systemic effects: No acute toxicological signs were observed in the animals during the test period, no mortalities occurred.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Remarks:
- EU
- Conclusions:
- The study was conducted under GLP according to OECD TG 405 on the registered substance itself. The method is to be considered scientifically reasonable with no deficiencies. Hence, the results can be considered as sufficiently reliable to assess the irritating properties of the test item.
According to Regulation (EC) 1272/2008 table 3.3.2, a substance must be classified as Irritating to eyes (Category 2), if, when applied to the eye of an animal, a substance produces:
— at least in 2 of 3 tested animals, a positive response of:
— corneal opacity ≥ 1 and/or
— iritis ≥ 1, and/or
— conjunctival redness ≥ 2 and/or
— conjunctival oedema (chemosis) ≥ 2
— calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days
In the present test, Cornea opacity is 1.66 in 2 of 3 animals, the other criteria are not met. However, this result is sufficient to classify the substance as Eye Irr. Cat. 2
No corrosion effect was observed at each of the measuring intervals. - Executive summary:
The eye irritating / corrosive properties of the test item were evaluated in a OECD 405 GLP study in three New Zealand White rabbits after single instillation of 100µl into the conjunctival sac. The test item showed a slight irritation when applied to the rabbit eye mucosa. No discoloration of the cornea and conjunctivae which could be related to effects of the test item was observed. The primary skin irritation Index was found to be 25.3 (unrinsed eyes). No corrosion effect was observed at each of the measuring intervals. Cornea opacity is 1.66 at 24, 48 and 72 hours after installation in 2 of 3 animals, so the substance should be classified as Eye Irr. Cat. 2 according to Regulation (EC) 1272/2008.
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