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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3 July 1995 to 24 July 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd.
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 3.01 kg
- Housing: Suspended metal cage
- Diet (e.g. ad libitum): Free access
- Water (e.g. ad libitum): Free access
- Acclimation period: 5 days minimum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24
- Humidity (%): 49 - 78
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
IN-LIFE DATES: NDA
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 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:
- One single exposure. Eye was not washed out after exposure.
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
- Time after start of exposure: N/A
SCORING SYSTEM: Draize Scale for scoring ocular irritation
TOOL USED TO ASSESS SCORE: UV light / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- See table below for raw data.
Reversibility of any observed effect: Changes fully reversible within 21 days - Other effects:
- At the time of dose administration, an initial pain reaction was apparent for the one animal dosed. A dulling of the normal corneal lustre was observed at 1 hour following dose administration. Iris scores of 1 and conjuctival scores of 2 (redness and chemosis) were also noted at 1 hour. At that time,residual test material was also noted around the treated eye. Corneal vascularization (invading up to 3 mm of the cornea) was observed at 7 days. Within 14 days, the vascularization was noted only along the bottom edge of the cornea (approximately 5 mm in length). All ocular effects subsided within 21 days.
Any other information on results incl. tables
Rabbit Number and Sex (Bodyweight kg) |
IPR = 3 |
||||||
157 Female (3.01) |
|||||||
Time After Treatment |
1 hr |
24 hr |
48 hr |
72 hr |
7 dy |
14 dy |
21 dy |
CORNEA E = Degree of Opacity F = Area of Opacity |
d
4 |
1*
4 |
2*
4 |
2*
4 |
2v*
4 |
1vv*
2 |
0
0 |
Score (E x F) x 5 |
0 |
20 |
40 |
40 |
40 |
10 |
0 |
IRIS D |
1* |
1* |
1* |
1* |
1* |
0 |
0 |
Score (D x 5) |
5 |
5 |
5 |
5 |
5 |
0 |
0 |
CONJUNCTIVAE A = Redness B = Chemosis C = Discharge |
2* 2* 3Re |
2* 2* 2 |
2* 2* 2 |
2* 2* 2 |
2* 2* 2 |
1 0 0 |
0 0 0 |
Score (A + B + C) x 2 |
14 |
12 |
12 |
12 |
12 |
2 |
0 |
Total Score |
19 |
37 |
57 |
57 |
57 |
12 |
0 |
Key: hr = hour(s) dy = day(s) IPR = initial pain reaction d = dulling of the normal lustre of the corneal surface Re = residual test material around treated eye v = circumcorneal vascularisation invading up to 3mm onto the cornea
* = positive effect vv = vascularisation along bottom ridge of cornea, approximately 5 mm in length, and invading up to 3 mm onto the cornea
Applicant's summary and conclusion
- Interpretation of results:
- other: risk of serious damage to eyes
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In the one animal tested, the test material produced irritation of the cornea, iris and conjunctivae. The level of ocular responses precluded treatment of additional animals. In this study, OS 114451A should be classified as causing the risk of serious damage to eyes (R 41), taking into account the scores obtained and the persistence of effects beyond day 14.
- Executive summary:
In a primary eye irritation study (525/035), 0.1mLof neat OS 114451Awas instilled into the conjunctival sac ofthe right eye of a female New Zealand White rabbit. The eye was not washed after treatment. The animal was then observed for21days. Irritation was scored by the method ofthe Draize scoring system.
In the one animal tested, the test material produced irritation of the cornea, iris and conjunctivae. The level of ocular responses precluded treatment of additional animals. In this study,OS 114451A should be classified as causing the risk of serious damage to eyes (R 41), taking into account the scores obtained and the persistence of effects beyond day 14.
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