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EC number: 240-941-6 | CAS number: 16898-52-5
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- Predates requirement of the LLNA and in vitro methods
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- Guideline study under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OTS 798.4100 (Skin Sensitisation)
- Principles of method if other than guideline:
- Similar to OECD 406, Buehler protocol
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- This in vivo study was undertaken for compliance with the U.S Federal Hazardous Substances Act, and predates the EU requirement to use the LLNA and in vitro methods in lieu of guinea pig studies. The repitition of an in vivo study in mice is not indicated, based on Article 25 of Regulation EC No. 1907/2006.
Test material
- Reference substance name:
- 1,1'-(1,3-Propanediyl)dipiperidine
- Cas Number:
- 16898-52-5
- Molecular formula:
- C13H26N2
- IUPAC Name:
- 1,1'-(1,3-Propanediyl)dipiperidine
- Test material form:
- solid
- Details on test material:
- Purity 100%, Brownish White Flaky Solid, Lot # 11202AB
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- 28 young adult Hartley Guinea Pigs, 14 from each sex, were used in the study.
Animals were purchased from a registered commercial breeding laboratory (Elm Hill Breeding Labs, Chelmsford, MA)
The animals weighed between 250-400 grams (21-43 days old) at the start of the study
Quarantined for 6-9 days.
Animals were group housed in stainless steel cages.
Hardwood chips were used as a contact bedding within the cages.
Animal rooms were maintained at 68 ±3 °F, with a relative humidity of 30-70%
Minimum of 10-13 air exchanges per hour
12 hour light/dark cycle using full spectrum fluorescent lights.
Animals were supplied with a diet of commercial guinea pig ration (Agway Prolab, Agway, Waverly, NY) and municipal tap water ad libitum
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- USP grade
- Concentration / amount:
- 25%
- Day(s)/duration:
- 6 hours/day, once weekly for 3 consecutive weeks
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- USP grade
- Concentration / amount:
- 25%
- Day(s)/duration:
- 24 hours, in week 5, a 2 week rest after induction
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 4
- Details on study design:
- A preliminary irritation study was performed with four previously unexposed animals before the start of the challenge phase. Four different concentration of 100%, 50%, 25%, and 10% were applied to the skin for 6 hours. Severe irritataion with necrosis was noted in the 100% group within 48 h; lesser degrees of irritation were found at 50% and 25%. 25% was chosen as the maximally tolerated dose for the sensitisation study.
In the main study, the test substance was applied once per week for 3 consecutive weeks on one side of the animal. The positive control substance was applied in the same manner. Induction scoring was performed 24 hours after the test substance application.
The day preceding the challenge, a 4x3 cm virgin skin site was shaved on the backs of the experimental and control animals. During week 05, the challenge test was performed on freshly clipped skin sites in the same way as the 6 hour closed patch test of the induction phase. The skin was exposed to the test substance for 24 hours. One virgin site was prepared per animal.
At 24 hours after application of the challenge dose, the area of the challenge was marked and the whole back shaved. Two hours after shaving, the test site was examined for erythema and edema.
At the end of the study, the animals were euthanised with CO2. - Positive control substance(s):
- yes
- Remarks:
- DCNB, 0.05-0.1% in acetone
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- no skin reactions or toxicity
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- no skin reactions or toxicity
- Remarks on result:
- other: valid negative control
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.05% DCNB
- No. with + reactions:
- 4
- Total no. in group:
- 4
- Clinical observations:
- 24 h score 2.25; 48 h score 2.75
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- valid positive control
Any other information on results incl. tables
Challenge with the test substance following 3 weeks of induction caused no erythema or edema in any of the 10 treated animals, either at 24 or 48 hours after elicitation. No reactions were noted in the negative control group, and 4/4 animals reacted in the positive control group. The score for the positive control at 24 h was 2.25, and at 48 h, was 2.75. Under the conditions of this study the test substance is not considered a skin sensitizer.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this guideline Buehler study in guinea pigs, the test substance is not considered a skin sensitiser.
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