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Diss Factsheets
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EC number: 946-308-7 | CAS number: -
- 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:
- september 15, 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Primary Dermal Irritation Test - 16 CFR 1500.41
- Version / remarks:
- Protocol 002/P201
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Cocamidopropyl PG-dimonium chloride
- Cas Number:
- 136920-08-6
- Molecular formula:
- C20-30H43-63ClN2O2 range
- IUPAC Name:
- Cocamidopropyl PG-dimonium chloride
- Test material form:
- other: aqueous solution
- Details on test material:
- Cocamidopropyl PG-dimonium chloride
Lot# D-273-36
Clear colorless liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- albino
- Details on test animals or test system and environmental conditions:
- Healthy, USDA certified six New zealand Albino Rabbits from Davidson's MILL farm.
1 male and 5 females.
Rabbits were selected based on their skin condition and health status.
Acclimatation period: 14 days
Caging- individually in suspended stainless steel caging with mesh floors.
Room temperature 20-21C
Food: pelleted Purina Rabbit Chow ad-libitum
Water: tap-water supplied by automatic water system
identification: a number was allocated to each rabbit on receipt.
application day: on sept 1, 1988, the test substance was applied to the intact and abraded test sites of each individual rabbit and occluded with adhesive-backed gauze patches secured in place with elastic wrapping
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 24 hrs
- Observation period:
- Skin sites were evaluated at approximately 24 hrs and 72 hrs after initial exposure
- Number of animals:
- 6 rabbits (1male / 5 females)
- Details on study design:
- six uniquely-identified rabbits were prepared by clipping the skin free of hair over approximately 10% of the body surface. Two test application sites, each approximately 2.5cm2 were delineated. One site was left intact, the other was abraded with a needle, taking special precaution not to penetrate the tratum corneum and not to cause bleeding. 0.5 mL of the test material was placed on each site and was immediately covered with 2x2-1/4 inch adhesive-hacked gauze patch. The patches and entire trunk of each rabbit were then wrapped with an elastic cloth to aid in maintaining test-patch position and to minimize evaporation. Neck collars were placed on each rabbit and the rabbits were returned to their individual cages. The neck collars and patches were removed after 24 hrs exposure at which time the test sites were gnetly wiped clean of any residual test material. Skin sites were evaluated at approximately 24 and 72 hrs after initial exposure and scoring according to 16 CFR 1500.41
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.043
- Remarks on result:
- no indication of irritation
- Remarks:
- non-primary skin irritant
- Irritant / corrosive response data:
- All animal appeared healthy and active. There were no sign of gross toxicity, adverse pharmacologic effects, or abnormal behavior.
One rabbit exhibited a slight erythema at the abraded site 24 hrs after dosing. This cleared by 72 hrs. No edema was observed at any time during the test period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- non-primary irritant according to FHSA dermal irritation test.
- Executive summary:
To determine irritant and/or corrosive effects of a single 24 hr exposure of the test substance on the intact skin and abraded skin of rabbits.
A sample of cocamidopropyl PG-dimonium chloride was tested as received, undiluted.
After acclimatation to the lab, six healthy New Zealand albino rabbits were clipped free of haire over approximately 10% of their body surface. Two test sites, each approximately 2.5cm2, were delineated. One was left intact and one was abraded. 0.5 mL of the test material was placed on each site and occluded for 24hrs. The patches were then removed and the test sites were wiped to prevent further exposure. The test sites were evaluated 24 and 72 hrs after initial exposure.
All animal appeared healthy and active. There were no sign of gross toxicity, adverse pharmacologic effects, or abnormal behavior.
One rabbit exhibited a slight erythema at the abraded site 24 hrs after dosing. This cleared by 72 hrs. No edema was observed at any time during the test period.
Summary scores and individual skin scores are available in the study report.
The Primary Dermal Irritation Index (PDII) was 0.043.
Based on scoring system used, the material is classified as non-primary skin irritant when applied as received, undiluted
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