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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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 June 1995 to 4 July 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd.
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.45 - 2.67 kg
- Housing: Supended metal cages
- Diet (e.g. ad libitum): Free access
- Water (e.g. ad libitum): Free access
- Acclimation period: Five days minimum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24
- Humidity (%): 45 - 59
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
IN-LIFE DATES: NDA
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): N/A
VEHICLE
- Amount(s) applied (volume or weight with unit): N/A (no vehicle used)
- Concentration (if solution): N/A
- Lot/batch no. (if required): N/A
- Purity: N/A - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 6 - 3 male and 3 female
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: NDA
- Type of wrap if used: TUBIGRIP
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material removed by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: Four hours after application
SCORING SYSTEM: Draize Scheme
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hr
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hr
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Irritant / corrosive response data:
- See table below for raw data.
Reversibility of any observed effect: Changes fully reversible within 7 days - Other effects:
- Scores of 1 or 2 for erythema/eschar and 1 for oedema were
noted in all animals at 1 hour. Desquamation (considered to
be reversible) was noted on 4 of 6 rabbits at 7 days.
Any other information on results incl. tables
Skin reaction |
Observation Time |
Individual Scores – Rabbit Number and Sex (Bodyweight kg) |
Total |
|||||
53 Male (2.51) |
9 Male (2.45) |
24 Female (2.53) |
33 Female (2.53) |
62 Male (2.67) |
81 Female (2.64) |
|||
Erythema / Eschar Formation |
1 Hour |
1 |
2 |
2 |
2 |
1 |
1 |
9 |
24 Hours |
1 |
1 |
1 |
1 |
1 |
1 |
6 |
|
48 Hours |
1 |
1 |
0 |
1 |
1 |
0 |
4 |
|
72 Hours |
1 |
0 |
0 |
1 |
1 |
0 |
3 |
|
7 Days |
0D |
0 |
0 |
0D |
0D |
0D |
0 |
|
Oedema |
1 Hour |
1 |
1 |
1 |
1 |
1 |
1 |
6 |
24 Hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
48 Hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 Hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7 Days |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Sum of 24 and 72- hour Readings (S) : 9 |
||||||||
Primary Irritation Index (S/12) : 9/12 = 0.75 |
||||||||
Classification : Mild irritant |
D = desquamation (considered reversible)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material, OS 114451A, produced a primary irritation index of 0.75 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme.
- Executive summary:
In a primary dermal irritation study (525/034),male and female New Zealand White rabbitswere dermally exposed to 0.5 mL of neat OS 114451A for 4 hours to a 2.5 x 2.5 cm area of skin. Animals then were observed for 3 days. Irritation was scored by the method of the Draize classification scheme.
All effects observed were reversible within the duration of the study period. Desquamation, which was considered to be reversible, was noted at four treated skin sites at the 7 day observation.In this study, OS 114451A is not classified as a dermal irritant.
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