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EC number: 421-660-1 | CAS number: - Z-27
- 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:
- 11 July 1995 to 10 September 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Bis(dimethyl-(2-hydroxyethyl)ammonium) 1,2-ethanediyl-bis(2-hexadecenylsuccinate)
- EC Number:
- 421-660-1
- EC Name:
- Bis(dimethyl-(2-hydroxyethyl)ammonium) 1,2-ethanediyl-bis(2-hexadecenylsuccinate)
- Molecular formula:
- Hill formula: C50 H96 N2 O10 CAS formula: C42 H74 O8. 2(C4 H11 N O)
- IUPAC Name:
- bis((2-hydroxyethyl)dimethylazanium) (4E)-3-{[2-({3-carboxylato-3-[(2E)-hexadec-2-en-2-yl]propanoyl}oxy)ethoxy]carbonyl}-4-methyloctadec-4-enoate
- Reference substance name:
- BIS(DIMETHYL-(2-HYDROXYETHYL)AMMONIUM) 1,2-ETHANEDIYL-BIS (2-HEXADECENYLSUCCINATE)
- IUPAC Name:
- BIS(DIMETHYL-(2-HYDROXYETHYL)AMMONIUM) 1,2-ETHANEDIYL-BIS (2-HEXADECENYLSUCCINATE)
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, Staffordshire
- Age at study initiation: approximately 4-5 weeks
- Weight at study initiation: 342 - 414 g
- Housing: Suspended metal cages with wire mesh floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 21
- Humidity (%): 30 - 70
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Intradermal injection: 0.25% v/v in Alembicol D
Topical application: 60.0% v/v in Alembicol D
Concentration of test material and vehicle used for each challenge:
40.0% and 20.0% v/v in Alembicol D
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Intradermal injection: 0.25% v/v in Alembicol D
Topical application: 60.0% v/v in Alembicol D
Concentration of test material and vehicle used for each challenge:
40.0% and 20.0% v/v in Alembicol D
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10 - Details on study design:
- RANGE FINDING TESTS: Based on the results of the preliminary investigations, the following concentrations of OS 114451A were selected:
Induction intradermal injection - 0.25% v/v in Alembicol D - this was the highest concentration that caused irritation but did not adversely affect the animals.
Induction topical application - 60% v/v in Alembicol D - the concentration of 70% was an irritant level and the concentration of 50% was a sub-irritant level. For this reason 60% was considered to be the most appropriate concentration for use in the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 - one intradermal injection follwed by topical application one week later
- Exposure period: Topical application - 48 hours
- Test groups: 1 group of 20
- Control group: 1 group of 10
- Site: Dorsal skin on the scapular region
- Frequency of applications: once per exposure route
- Duration: Topical application - 48 hours
- Concentrations: Injection - 0.25% v/v in Alembicol D, Topical application - 60% v/vin Alembicol D
B. CHALLENGE EXPOSURE
- No. of exposures: 4 - two topical applications at different doses, followed by two further topical applications at the same two doses three weeks later
- Day(s) of challenge: NDA
- Exposure period: 24 hours per challenge
- Test groups: 1 group of 20
- Control group: 1 group of 10
- Site: Dorsal skin on the scapular region. First challenge on left flank, 40% v/v dose on anterior site, 20% v/v dose on posterior site. Second challenge on right flank, 40% v/v dose on anterior site, 20% v/v dose on posterior site.
- Concentrations: 40% v/v and 20% v/v
- Evaluation (hr after challenge): 24, 48 and 72 hours after removal of the patches
OTHER: None - Challenge controls:
- - No. of exposures: 4 - two topical applications at different doses, followed by two further topical applications at the same two doses three weeks later
- Day(s) of challenge: NDA
- Exposure period: 24 hours per challenge
- Test groups: 1 group of 20
- Control group: 1 group of 10
- Site: Dorsal skin on the scapular region. First challenge on left flank, 40% v/v dose on anterior site, 20% v/v dose on posterior site. Second challenge on right flank, 40% v/v dose on anterior site, 20% v/v dose on posterior site.
- Concentrations: 40% v/v and 20% v/v
- Evaluation (hr after challenge): 24, 48 and 72 hours after removal of the patches - Positive control substance(s):
- yes
- Remarks:
- hexyl cinnamic aldehyde
Results and discussion
- Positive control results:
- The sensitivity of the guinea-pig strain used is checked periodically at the testing laboratory with hexyl cinnamic acid, a known sensitiser. The results of recent tests are presented in the report and adequately demonstrate a positive sensitisation response.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 40 %
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 40 %. No with. + reactions: 14.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20 %
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20 %. No with. + reactions: 8.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 40 %
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 40 %. No with. + reactions: 14.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20 %
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20 %. No with. + reactions: 11.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 40 %
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 40 %. No with. + reactions: 17.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20 %
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 20 %. No with. + reactions: 6.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 40 %
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 40 %. No with. + reactions: 17.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20 %
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 20 %. No with. + reactions: 8.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 40 %
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 40 %. No with. + reactions: 2.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 20 %
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 20 %. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 40 %
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 40 %. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 20 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 20 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 40 %
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 40 %. No with. + reactions: 3.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 20 %
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 20 %. No with. + reactions: 2.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 40 %
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 40 %. No with. + reactions: 4.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 20 %
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 20 %. No with. + reactions: 4.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 50 %
Signs of irritation during induction:
Intradermal: Slight irritation in both test and control
animals, and necrosis at sites receiving Freund's complete
adjuvant.
Topical: Test and control animals had slight erythema on the
dosed areas.
Evidence of sensitisation of each challenge concentration:
First Challenge Dose (40.0%):
A total of 14/20 test animals exhibited reactions greater
than the controls (ranging from slight erythema and edema towell-defined erythema with or without edema) at the 24, 48
and/or 72 hr observation periods.
First challenge dose (20.0%): Nine of 20 test animals had
reactions greater than that observed in the controls(ranging, as described above, from slight erythema and edema
to well-defined erythema with or without edema).
Second challenge dose (40.0%): Two control animals out of10 showed well defined erythema at either 24 or 48 hours.Twelve test animals out of 20 showed well defined erythemaat either 24 or 48 hours. Well defined erythema was still
present at 72 hours in 10 test animals. Two animals had
necrosis on the dosed area.
Second challenge dose (20.0%): Four of 10 control animals
had reactions at 24, 48, and/or 72 hr. These reactions
ranged from slight, localized erythema to slight erythema
and edema. Three test animals had well-defined erythema with
slight edema.
Other observations:
Other skin irritation: Most test animals also exhibited
dryness, sloughing and/or thickening of the epidermis at 24,
48 and/or 72 hr following the first and second challenge
doses.
Bodyweight: All animals exhibited a bodyweight increase
during the study.
Clinical signs: There were no signs of clinical toxicity
observed for any animal during the study.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- In this study, OS 114451A produced evidence of skin sensitisation (delayed contact hypersensitivity) in three of the twenty test animals.
- Executive summary:
In a dermal sensitization study (LBL 16/952362/SS) withOS 114451A in Alembicol D, thirty 4-5 week old Dunkin/Hartley male guinea pigs were tested using the method of EC Directive 92/69/EEC, Method B6 skin sensitisation. The positive control material was hexyl cinnamic aldehyde. No signs of ill health or toxicity were observed.
In this study, OS 114451A produced evidence of skin sensitisation (delayed contact hypersensitivity) in three of the twenty test animals.
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