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EC number: 915-687-0 | CAS number: 1065336-91-5
- 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)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 5, 1988 - May 19, 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 1981
- Qualifier:
- according to guideline
- Guideline:
- other: Magnusson and Kligman (J. invest. Dermatol. 52, 268-276, 1969, Cont. Dermatitis 6, 46-50, 1980),
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Several valid guinea pig studies are available, no further information from an LLNA is required.
Test material
- Reference substance name:
- 1-methyl 1,2,2,6,6-pentamethylpiperidin-4-yl decanedioate; bis(1,2,2,6,6-pentamethylpiperidin-4-yl) decanedioate
- EC Number:
- 915-687-0
- Cas Number:
- 1065336-91-5
- Molecular formula:
- unspecified
- IUPAC Name:
- 1-methyl 1,2,2,6,6-pentamethylpiperidin-4-yl decanedioate; bis(1,2,2,6,6-pentamethylpiperidin-4-yl) decanedioate
- Details on test material:
- - Physical state: liquid, insoluble in water
- Storage condition of test material: room temperature
In addition to the test compound, the following leather samples were used in the challenge reactions:
B = blind sample
C = treated sample, compounds solubilized in buthylacetate
D = treated sample, compounds solubilized in a nitrolacquer
Constituent 1
- Specific details on test material used for the study:
- In addition to the neat test material, leather patches treated with the test material were used in addition for challenge reactions.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 331 to 424 g
- Housing: individually in Macrolon cages (Type 3)
- Diet: ad libitum standard guinea pig pellets - NAFAG No. 846, Gossau SG
- Water: ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: seame oil
- Concentration / amount:
- 1%
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 30%
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 10%
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 male and 10 females per group
- Details on study design:
- RANGE FINDING TESTS:
The concentrations of the test article for the induction and challenge periods were determined on separate animals.
MAIN STUDY
A. INDUCTION EXPOSURE
The induction was a two-stage operation. First, intradermal injections (into the neck region); second, closed patch exposure over the injection sites. Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the shaved neck of the guinea pigs as follows: adjuvant and saline (1:1), test compound in sesame oil, test compound in the adjuvant saline mixture. Concentration of test compound in sesame oil and adjuvant mixture: 1 %. One week later the test compound was incorporated in vaseline and applied on a filterpaper patch to the neck of the animals (patch 2 x 4 cm; occluded administration for 48 hours). Dose of application: approx. 0.4 g paste of 30 % test compound in vaseline.
B. CHALLENGE EXPOSURE
First challenge: two weeks after the epidermal induction application the animals were tested on the flank with test compound in vaseline and with the blind leather patch sample B (patch 2 x 2 cm; occluded administration for 24 hours). Dose of application: approx. 0.2 g paste of 10 % test compound in vaseline.
Second Challenge: After a further rest period of 10 days, a second challenge application was performed. The animals were treated on the contralateral flanks with one patch of the treated leather fabrics C and D. Twenty four hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale. A second evaluation was made 48 hours after removing the dressings.
CONTROL GROUP
A control group was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the neat test compound (at least 10 animals) to control the maximum subirritant concentration of the test article in adjuvant treated animals. Separate animals were treated with test compound and the leather samples to control the primary irritant effects. On account of experience from other experiments 3% and 10% test compound were tested in vaseline. No erythema reactions were induced with both concentrations. Therefore 10 % was used as the maximum subirritant concentration for the challenge application with the test compound.
Results and discussion
- Positive control results:
- The sensitivity of the strain is checked every six months with Paraphenylene-diamine or Potassium-diehromate.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- all leather samples
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- all leather samples
- No. with + reactions:
- 0
- Total no. in group:
- 20
Any other information on results incl. tables
Under the experimental conditions employed, 14 animals of the test group reacted to the neat product 24 and 48 hours after removing the dressing . No reactions were elicited with the treated leather samples.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- 70% of the animals were sensitized by the test compound under the experimental conditions employed. But none of the animals reacted to the challenge application of leather patches treated with the test compound. According to the maximization grading the neat test compound showed a strong grade of skin-sensitizing (contact allergenic) potential in albino guinea pigs.
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