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EC number: 417-440-8 | CAS number: 2516-92-9
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4100 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Deviations did not affect the outcome of the study.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A guinea pig maximisation study was available, therefore a LLNA method was not necessary.
Test material
- Reference substance name:
- 1,10-bis(2,2,6,6-tetramethyl-1-piperidinyloxy)-1,10-dioxodecane
- EC Number:
- 417-440-8
- EC Name:
- 1,10-bis(2,2,6,6-tetramethyl-1-piperidinyloxy)-1,10-dioxodecane
- Cas Number:
- 2516-92-9
- Molecular formula:
- C28 H50 N2 O6
- IUPAC Name:
- bis(1-hydroxy-2,2,6,6-tetramethylpiperidin-4-yl) decanedioate
- Details on test material:
- Identification code (lab) = TKA 40075
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Remarks:
- albino
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague Dawley, Inc., Houston, Texas
- Females (if applicable) nulliparous and non-pregnant: not specified
- Microbiological status of animals, when known: not known
- Age at study initiation:
- Weight at study initiation:
Males (285-340g); Females (290-320g) (at time of testing)
- Housing:
Cage Type: Suspended, wire bottom, stamless steel
Housing: One per cage
Transfer to Clean Cages: Weekly
Litter Pan Lining: Paper
Litter Pan Lining Change: Three times weekly
Food: Purina Gumea Pig Chow; available ad libitum
Water Type: Tap; available ad libitum
Water System: Automatic
- Acclimation period: At least five days
- Indication of any skin lesions: not specified
- IN-LIFE DATES: From: June 17, 1992 To: July 11, 1992
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- propylene glycol
- Concentration / amount:
- For the test animals, the first pair of injections (one on each side of the spine column and approximately 3.5 cm apart), consistmg of Freund's Complete Adjuvant diluted to 50% v/v in 0.9% saline, was made at the anterior edge of the exposure area.
The second pair of injections, consisting of 2% w/v test material in propylene glycol vehicle, was made approxunately 0.5 cm behind the first pair of injections.
The third pair of injections, consisting of a 50:50 mixture of Freund's Complete Adjuvant (diluted to 50% v/v in 0.9% salme) and 2% w/v test material in vehicle, was made approximately 1.0 cm behind the second pair. - Day(s)/duration:
- on day 0
- Adequacy of induction:
- other: an intermediate dose of 2% w/v test material in propylene glycol was selected for the intradermal induction.
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- a 2 x 4 cm patch of filter paper with 0.5 ml of 25% w/w test material m petrolamm was placed over the exposure areas to cover the three paks of injection sites of each test group animal.
- Day(s)/duration:
- On day 7
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 25% w/w test material m petrolatum for topical applications
- Day(s)/duration:
- on day 21
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 15
- Details on study design:
- RANGE FINDING TESTS:
Six healthy, short-haured, albino guinea pigs (3 males and 3 females) were released from quarantine for pre-testing. The animals were clipped prior to dosing. One male and one female received intradermal injections at different sites of 0.1 ml each of 1%, 2%, 4% and 5% w/v test material in propylene glycol (vehicle), as well as two 0.1 ml injections per animal of vehicle only. Observations were made at 24 and 48 hours after injection. Of the remaining four animals, one male and one female received 0.5 ml applications of 5% and 15% w/w test material in petrolatum, and one male and one female received 0.5 ml of 20% and 25% w/w test material m petrolatum. Observations were made at 48 hours after application. Significant irritation was seen with all
intradermal doses screened, including vehicle alone, and an intermediate dose of 2% w/v test material in propylene glycol was selected for the intradermal induction. No irritation was observed after any of the extemal cutaneous doses screened. The highest dose, 25%, was selected for cutaneous application on Day 7 and at challenge.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 21 days
- Test groups: 1
- Control group: 1
- Site:
All injections were within a 2 X 4 cm area of the 4 x 6 cm exposure are
- Frequency of applications: at day 0 and 7.
- Duration: 21 days
- Concentrations:
For the test animals, the first pair of injections (one on each side of the spine column and approximately 3.5 cm apart), consistmg of Freund's Complete Adjuvant diluted to 50% v/v in 0.9% saline, was made at the anterior edge of the exposure area.
The second pair of injections, consisting of 2% w/v test material in propylene glycol vehicle, was made approxunately 0.5 cm behind the first pair of injections.
The third pair of injections, consisting of a 50:50 mixture of Freund's Complete Adjuvant (diluted to 50% v/v in 0.9% salme) and 2% w/v test material in vehicle, was made approximately 1.0 cm behind the second pair.
On Day 7, a 2 x 4 cm patch of filter paper with 0.5 ml of 25% w/w test material in petrolatum was placed over the exposure areas to cover the three pairs of injection sites of each test group animal. The patch was then occluded with an unpermeable plastic adhesive tape and secured in place with an elastic adhesive tape wound around the torso of the animal. A patch of filter paper with 0.5 ml of petrolatum only was placed over the exposure areas of the control group animals. The wrappings and patches were removed after 48 hours.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 3
- Exposure period: 1 day
- Test groups: 1
- Control group: 1
- Site: a 5 x 5 cm area was clipped on both the left and right flanks of each anunal.
- Concentrations:
A 2 x 2 cm patch of filter paper with 0.5 ml of 25% w/w test material in petrolatum was applied topically to the right flank of each test animal in a manner identical to the Day 7 treatment. A 2 x 2 cm patch of filter paper with 0.5 ml of petrolatum was applied to the left flank of each test animal for a control site. A 2 x 2 cm patch of filter paper with 0.5 ml of petrolatum only was applied topically to the right flank of the control ammals. A 2 x 2 cm patch of dry filter paper was applied to the left flank of each control animal for an untreated control site.
- Evaluation (hr after challenge):
On Day 22 (24 hours after challenge), the wrappings and patches were removed. On Day23 (24 hours after unwrapping), the test sites were observed for sldn reactions, and again on Day 24 (44 hours after unwrapping).
- Challenge controls:
- A 2 x 2 cm patch of filter paper with 0.5 ml of petrolatum only was applied topically to the right flank of the control ammals. A 2 x 2 cm patch of dry filter paper was applied to the left flank of each control animal for an untreated control site.
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Treatment (25% w/w test material in petrolatum)
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- Treatment (25% w/w test material in petrolatum)
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Control (no test material)
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- Control (no test material)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 25 %
Signs of irritation during induction: Moderate erythema (2-3 grade), slight oedema (1-2 grade).
The test material, GUlO-415, appeared to produce a sensitizing reaction in three of twenty, or 15%, of the test animals. However, one of the ten controls, 10%, received a similar skin reaction score. The test material is therefore rated as a weak sensitizer in albino guinea pigs.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No classificaiton of GU 10-415 is needed based on the guinea pig maximisation test.
- Executive summary:
A maximization test for topically applied test materials was conducted on 30 short-haired male and female albino guinea pigs to determine if the test article labeled GU10-415, produced a sensitizing reaction.
Twenty guinea pigs each received three pairs of intradermal injections (adjuvant, a 2% w/v solution of the test material, and a mixture of adjuvant and 2% w/v solution of test material) followed one week later by a single topical application of the test material at 25% w/w in. petrolatum. Two weeks after the topical application, the animals were challenged with a second topical application of the test material at 25% w/w petrolatum at a virgin test site. Ten additional animals served as a control group. Control animals were treated at the same time periods and locations but with the vehicle used in place of the 2% w/v solution of test material. The percentage of animals exhibiting erythema and/or edema after the challenge treatment was used to assign the test material a sensitization potency rating.
The test material, GU10-415, appeared to produce a sensitizing reaction in three of twenty, or 15%, of the test animals. However, one of the ten controls, 10%, received a similar skin reaction score. According to the CLP guidelines, GU10 -415 does not have to be classified as a skin sensitizer.
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