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EC number: 287-487-5 | CAS number: 85536-06-7
- 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
Specific investigations: other studies
Administrative data
- Endpoint:
- specific investigations: other studies
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 13 Jun - 01 Jul 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study report which meets basic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
- Principles of method if other than guideline:
- Comedogenicity study in rabbits
- GLP compliance:
- yes
- Type of method:
- in vivo
Test material
- Reference substance name:
- Glycerides, C8-18
- EC Number:
- 287-487-5
- EC Name:
- Glycerides, C8-18
- Cas Number:
- 85536-06-7
- Molecular formula:
- Not applicable: Complex UVCB substance
- IUPAC Name:
- Glycerides, C8-18 (even numbered)
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: ivory cream
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Davidson's Mill Farm, S. Brunswick, NJ, USA
- Weight at study initiation: 3.3 kg (male), 3.2 and 3.6 kg (females)
- Housing: individual caging in suspended stainless steel cages with mesh floor
- Diet: Pelleted Purina Rabbit Chow, ad libitum
- Water: tap water supplied by automatic water system
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.8-21.1
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- TEST SITE
- Area of exposure: internal base of the left ear
TEST MATERIAL
- Amount applied: not specified; the test material was applied with a glass rod to ensure complete coverage of the test site. - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 3 weeks
- Frequency of treatment:
- daily, 5 days/week
- Post exposure period:
- No post-exposure period
- No. of animals per sex per dose:
- 1 male, 2 females
- Control animals:
- other: the untreated ear of the same animal served as negative control
Examinations
- Examinations:
- BODY WEIGHT
Body weights were recorded prior to testing and at terminal sacrifice.
EVALUATION OF COMEDOGENICITY
- Macroscopic evaluation
Prior to each application, the test site and the negative control ear were scored for hyperkeratosis and comedone formation according to the following "in vivo and histological comedogenicity scoring scale" (Fulton et al., 1976. Non-comedogenic cosmetics. Cutis 17:344-351):
Score 0: no increase in visible follicular hyperkeratosis
Score 1: an increase in visible hyperkeratosis
Score 2: an increase in visible hyperkeratosis extending to the possible presence of comedones
Score 3: significant comedones
Score 4: significant comedones
Score 5: severe lesions
- Microscopic evaluation
After the last macroscopic evaluation, the rabbits were sacrificed and the ears were excised, preserved in 10% buffered formalin and prepared for histological examination for the presence of comedones.
Results and discussion
- Details on results:
- OBSERVATIONS
All animals appeared active and healthy during the test period. There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour.
BODY WEIGHT
All animals gained weight.
EVALUATION OF COMEDOGENICITY
Slight hyperkeratosis was observed on the treated ears during the 3-week dosing period. The control ears were clear.
Histological scores were 2 for all treated ears and 0 for all controls. This indicated the presence of hyperkeratosis and some resultant keratin material in the follicles. The presence of follicular comedones was not noted.
Applicant's summary and conclusion
- Conclusions:
- The test substance causes follicular hyperkeratosis but does not cause comedone formation after being applied neat, 5 days/week for 3 consecutive weeks.
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