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Diss Factsheets
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EC number: 252-478-7 | CAS number: 35274-05-6
- 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
Endpoint summary
Administrative data
Description of key information
Although the study was not performed according to presently available test mehods, the total lack of response makes it possible to take a reliable conclusion with respect to sensitizing potential of the test substance.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1958
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: study done in pre-GLP period but sufficient detail reported
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The method used was based on scientifically accepted method.
- GLP compliance:
- no
- Type of study:
- intracutaneous test
- Justification for non-LLNA method:
- The alternative method used was based on scientifically accepted method and was performed before the LLNA requirement.
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- the text animals were normal and healthy and were feed with rabbit pellets supplemented with spinach and kale through out the course of the experiment.
- Route:
- intradermal
- Vehicle:
- other: physiological saline
- Concentration / amount:
- 0.1% / 0.05 - 0.1 ml
- Day(s)/duration:
- 10 injections each every other day
- Adequacy of induction:
- not specified
- Route:
- intradermal
- Vehicle:
- other: physiological saline
- Concentration / amount:
- 0.1% / 0.5 ml
- Day(s)/duration:
- Two weeks after the final test injection
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 8
- Details on study design:
- Reaction readings were made 24 h after each injection.
- Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 %
- No. with + reactions:
- 22
- Total no. in group:
- 70
- Clinical observations:
- Not specified
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 7
- Clinical observations:
- Not specified
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material is not sensitizing.
- Executive summary:
Alhough a small raised area was observed with a slight increase in color when compared to surrounding area, but the retest reading value was less than the average for each reading. Thus, the substance can be said not to have produced sensitization.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
CERAPHYL® 28 with hexadecyl lactate as main constituent was not a sensitizer to guinea pig skin. Eight healthy male guinea pigs were treated using intracutaneous injections of 0.1% CERAPHYL® 28 in physiological saline every other day for a total of ten injections. The first injection was 0.05 ml and the remaining injections were 0.1 ml. Two weeks following the tenth injection, all animals were challenged with 0.05 ml of freshly prepared solution of CERAPHYL® 41 slightly below their sensitizing area . On the challenge injection, none of the test animals exhibited reactions higher than the average of the original scores. Although the test method is not equivalent to the method described in international guidelines, the total lack of response indicates that the test material is not sensitizing. In addition, comparable studies with other long-chain akyl lactates show that these are not sensitizing.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The test material was not classified since it did not induce sensitization. However, due to lack of data, no decision can be made regarding respiration sensitisation.
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