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EC number: 272-897-9 | CAS number: 68919-40-4
- 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:
- no specified (1978)
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Occlusive dressing instead of non-occlusive. Half of the treated area was abraded. The animals were exposed for 24 hours instead of 4 hours and observed for 72 hours instead of 14 days.
- GLP compliance:
- no
Test material
- Reference substance name:
- Imidazolium compounds, 1-[2-(2-carboxyethoxy)ethyl]-1(or 3)-(2-carboxyethyl)-4,5-dihydro-2-norcoco alkyl
- EC Number:
- 272-897-9
- EC Name:
- Imidazolium compounds, 1-[2-(2-carboxyethoxy)ethyl]-1(or 3)-(2-carboxyethyl)-4,5-dihydro-2-norcoco alkyl
- Cas Number:
- 68919-40-4
- Molecular formula:
- R_C8 H14 N2 O4 Na With R=Cn H2n+1 n=8, 10, 12, 14, 16, 18
- IUPAC Name:
- disodium 3-({2-[N-(2-hydroxyethyl)hexadecanamido]ethyl}amino)propanoate 3-[(2-hexadecanamidoethyl)(2-hydroxyethyl)amino]propanoate
- Test material form:
- solid - liquid: aqueous solution
- Details on test material:
- - Batch No.: 4324D78
1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 4324D78
- Expiration date of the lot/batch: not specified
- Purity test date: not specified
Test animals
- Species:
- rabbit
- Strain:
- other: albino rabbit
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not specified
- Age at study initiation: not specified
- Weight at study initiation: not specified
- Housing: in racks
- Diet (e.g. ad libitum): not specified
- Water (e.g. ad libitum): not specified
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not specified
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): not specified
IN-LIFE DATES: not specified
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped and abraded areas
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL on each area (scarified and unscarified) - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure:
- % coverage: 10% of the total body area was clipped free of hair the day prior the exposure. The test article was applied to a 2.0 x 2.0 cm clipped area of both intact and abraded skin
- Type of wrap if used: The 2 x 2 patch area was covered with Webril patches and the entire experimental area sealed with Blenderm Surgical Tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
- Time after start of exposure: 24 hours
OBSERVATION TIME POINTS : 24 and 72 jours
SCORING SYSTEM:
- Method of calculation: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- mean
- Remarks:
- mean score of the 3 animals (individual scores of each animal were not reported in the study report)
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- not specified
- Remarks:
- Skin reactions were still observed after the 72-hours observation period.
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- mean
- Remarks:
- mean score of the 3 animals (individual scores of each animal were not reported in the study report)
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- not specified
- Remarks:
- Skin reactions were still observed after the 72-hours observation period.
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- mean
- Remarks:
- mean score of the 3 animals (individual scores of each animal were not reported in the study report)
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- not specified
- Remarks:
- Skin reactions were still observed after the 72-hours observation period.
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- mean
- Remarks:
- mean score of 3 animals (individual scores of each animal were not reported in the study report)
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- not specified
- Remarks:
- Skin reactions were still observed after the 72-hours observation period.
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Remarks:
- mean score of the 3 animals (individual scores of each animal were not reported in the study report)
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- not specified
- Remarks:
- Skin reactions were still observed after the 72-hours observation period.
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Remarks:
- means score of the 3 animals (individual scores of each animal were not reported in the study report)
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks:
- Skin reactions were still observed after the 72-hours observation period.
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- mean
- Remarks:
- mean score of the 3 animals (individual scores of each animal were not reported in the study report)
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- not specified
- Remarks:
- Skin reactions were still observed after the 72-hours observation period.
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- mean
- Remarks:
- mean score of the 3 animals (individual scores of each animal were not reported in the study report)
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks:
- Skin reactions were still observed after the 72-hours observation period.
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on an in vivo skin irritation test in rabbits, the registered substance is not be classified as a skin irritant according to CLP and GHS UN criteria.
- Executive summary:
The registered substance (product name = MIRANOL C2M Anhydrous Acid) has been tested for acute skin irritation in 3 New Zealand White rabbits. The test article, a liquid, was applied in a single dermal dose of 0.5 ml to a 2.0 x 2.0 cm clipped area of both intact and abraded skin, under an occlusive dressing for a 24-hour exposure period. Cutaneous examinations were performed at 24 hours, at removal of the dressing, and then at 72 hours.
Both on intact and abraded skin, the average score calculated over the 3 animals at 24 hours was 2.0 for erythema, and 1.0 at 72 hours. Oedema reaction was observed at 24 hours on both intact or abraded skin areas, but the reaction had cleared by 72 hours. The average score calculated over the 3 animals at 24 hours was 1.0 for both intact skin and abraded skin areas.
Considering the maximalized conditions of application (occlusive application during 24 hours), and the mild cutaneous reactions observed under these conditions, it can be concluded that the registered substance is not be classified as a skin irritant according to CLP and GHS UN criteria.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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