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EC number: 946-944-5 | CAS number: -
- 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:
- 1 October 1999 - 14 March 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The Buehler test is a standard method to asses the skin sensitisation characteristics of a chemical according to OECD TG 406.
Test material
- Reference substance name:
- Alcohols, C12-14 (even numbered), propoxylated, aminated
- EC Number:
- 946-944-5
- Molecular formula:
- C12H27N (C3H6O)n n=1-5, C14H31N (C3H6O)n n=1-4
- IUPAC Name:
- Alcohols, C12-14 (even numbered), propoxylated, aminated
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: test material was provided by the sponsor
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Elm Hill Breeding Laboratories
- Age at study initiation: 5 weeks (assay), 7 weeks (naives)
- Weight at study initiation: 290- 347g (dose range finding); 302- 418g (assay); 482- 572g (naives)
- Housing: individual housing
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
- Indication of any skin lesions: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-26
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: 25 October 1999 To: 1 December 1999
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.3ml of 3% solution of test item
- Day(s)/duration:
- three 6h applications seven days between each application
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.3ml of 1% solution of test item
- Day(s)/duration:
- 6h application 14 days after the last induction exposure
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.3ml of 0.5% solution of test item
- Day(s)/duration:
- 6h application, 7 days after challenge
- No. of animals per dose:
- dose range finding study: 8 animals
main study: vehicle control 10 animals, test item 20 animals, postive control 6 animals, 4 naive animals in re-challenge phase - Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6h
- Test groups: 20 animals (10 males and 10 females)
- Control group: 10 animals (5 males and 5 females)
- Site: left flank
- Frequency of applications: test item was applied 3 times, seven days between applications
- Concentrations: 3%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after the last induction application
- Exposure period: 6h
- Test groups: 20 animals (10 males and 10 females)
- Control group: 10 animals (5 males and 5 females)
- Site: left or right flank
- Concentrations: 1%
- Evaluation (hr after challenge): 24h
OTHER:
RE- CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 6h
- Test groups: 20 animals (10 males and 10 females)
- Control group: 4 naive animals (2 males and 2 females)
- Site: left or right flank
- Concentrations: 0.5%
- Evaluation (hr after challenge): 24h - Challenge controls:
- The control group was challenged with the vehicle on one site and with the test item on another site
- Positive control substance(s):
- yes
- Remarks:
- DNCB 0.3%
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: vehicle control challenged with test item
- Dose level:
- 1%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: vehicle control challenged with test item
- Dose level:
- 1%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.02%
- No. with + reactions:
- 1
- Total no. in group:
- 6
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.02%
- No. with + reactions:
- 2
- Total no. in group:
- 6
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.2%
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.2%
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- other: naive control (not induced) challenged with test item
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- other: naive control (not induced) challenged with test item
- Dose level:
- 0.5%
- No. with + reactions:
- 1
- Total no. in group:
- 4
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 5
- Total no. in group:
- 20
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study the induction with the test item at 3% did not elicit a delayed contact hypersensitivity response in guinea pigs when challenged with the test article at 1% or when rechallenged at 0.5%.
- Executive summary:
The purpose of the study was to determine the potential of the test material to elicit a delayed dermal contact hypersensitivity in guinea pigs by measurement of skin reactivity. The irritation potential of the test article was first determined by a dose ranging study. Based on the results of the dose range finding study 3% was chosen for the induction phase of this study as it produced mild irritation. For the challenge phase the test article was dosed at 1%, the highest non irrtating concentration and at re-challenge at 0.5%.
For the induction phase 10 guinea pigs (5/sex) in the vehicle control group were induced with three 6h occluded dermal application of distilled water, with 7 days between applications. A test item group of 20 animals (10/sex) was induced in the same manner with the test item at 3%. A positive control group of 6 animals (3/sex) was induced with a known dermal sensitiser DNCB 0.3% in ethanol. All animals were observed for dermal irritation and scored 24 and 48h after each application.
Fourteen days after the last induction all animals were challenged with occluded application on naive test sites. All animals in the vehicle control group were challenged with the vehicle (distilled water) and the test item at 1% on separate sites. All animals in the test group were challenged with the test item at 1%. All animals in the postive control group were challenged with DNCB (in acetone) at 0.02% and 0.2%. 24h after the challenge the animals were depilated and scored for dermal irritation. The scoring was repeated at 48h.
The re-challenge with the test item at 0.5% was repeated 7 days after the primary challenge.
Under the conditions of the study the induction with the test item at 3% did not elicit a delayed contact hypersensitivity response in guinea pigs when challenged with the test article at 1% or when rechallenged at 0.5%.
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