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EC number: 619-057-3 | CAS number: 94667-33-1
- 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:
- July 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes
Test material
- Reference substance name:
- bis(decyl)(2-hydroxyethyl)methylazanium propanoate
- EC Number:
- 619-057-3
- Cas Number:
- 94667-33-1
- Molecular formula:
- C29 H62 N O4 . C3 H5 O2
- IUPAC Name:
- bis(decyl)(2-hydroxyethyl)methylazanium propanoate
- Reference substance name:
- alpha.-[2-(Didecylmethylammonio)ethyl]-.omega.-hydroxy-poly(oxy-1,2-ethanediyl) propionate
- IUPAC Name:
- alpha.-[2-(Didecylmethylammonio)ethyl]-.omega.-hydroxy-poly(oxy-1,2-ethanediyl) propionate
- Reference substance name:
- N,N-Didecyl-N-methyl-poly(oxyethyl)ammonium Propionate
- IUPAC Name:
- N,N-Didecyl-N-methyl-poly(oxyethyl)ammonium Propionate
- Reference substance name:
- Bardap 26
- IUPAC Name:
- Bardap 26
- Details on test material:
- The test material was Bardap 26 described as a clear, yellow liquid. The test substance was stored at 22°C in the dark in a fume hood.
The deviation in composition of the old test material to the current specifications is considered not to have any impact on the outcome of the study.
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- The animals were 3-5 month old New Zealand White rabbits obtained from Hoechst AG, Kastengrund, Germany. The rabbits weighed 2.8-3.7 kg. The animals were housed individually, temperature was maintained at 20 ± 3°C and relative humidity was maintained at 50 ± 20% with a 12 hour light/dark cycle. The rabbits were fed Altromin 2123 Haltungsdiat - Kaninchen ad libitum, and provided with deionised chlorinated water ad libitum.
In-life date was 2 July 1985.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml undiluted test substance/eye
- Duration of treatment / exposure:
- Single instillation
- Observation period (in vivo):
- 6 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- 24 hours prior to administration, the eyes were examined under a UV-light for potential damage of the cornea after instillation of a drop of sodium fluorescein solution (0.01%). Only animals with normal eyes were used for the study.
A single dose of 0.1 ml of test substance was instilled into the conjunctival sac of the left eye of 3 rabbits. The untreated eyes served as a control.
Eye reactions were evaluated at 1 and 6 hours post-instillation. The study was terminated at 6 hours due to the severity of the effects observed. Reactions were scored according to the system set out in EU Method B.5.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- probability of severe irritation
- Remarks:
- 1 hour post-instillation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- probability of severe irritation
- Remarks:
- 6 hours post-instillation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: a clear discharge was observed
- Remarks:
- 1 hour post-instillation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: a clear discharge was observed
- Remarks:
- 6 hours post-instillation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Max. score:
- 2
- Reversibility:
- other: tent of conjunctival swelling
- Remarks on result:
- other: Effects on the iris could not be assessed due to the extent of conjunctival swelling
- Remarks:
- 1 and 6 hours post-instillation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Max. score:
- 3
- Reversibility:
- other: Conjunctival redness could not be assessed due to the extent of conjunctival swelling
- Remarks on result:
- other: Conjunctival redness could not be assessed due to the extent of conjunctival swelling
- Remarks:
- 1 and 6 hours post-instillation
- Irritant / corrosive response data:
- At 1 and 6 hours post-instillation, the eyes were half closed due to swelling. Corneal opacities (grade 4), conjunctival swelling (grade 3 at 1 hour and grade 4 at 6 hours) and a clear discharge were seen in all animals. Effects on the iris and conjunctival redness could not be assessed because of the extent of the swelling.
- Other effects:
- No other effects reported.
Any other information on results incl. tables
Table 1. Individual eye irritation scores
Time after application |
1 hour |
6 hours |
||||
Animal No. |
1 |
2 |
3 |
1 |
2 |
3 |
Chemosis |
3 |
3 |
3 |
4 |
4 |
4 |
Redness |
D |
D |
D |
D |
D |
D |
Iris |
S |
S |
S |
S |
S |
S |
Opacity |
4 |
4 |
4 |
4 |
4 |
4 |
|
|
|
|
|
|
|
Discharge |
||||||
- clear |
x |
x |
x |
x |
x |
x |
Conjunctivae |
||||||
- discoloured white |
x |
x |
x |
x |
x |
x |
D = evaluation impossible due to severe chemosis and white discolouration
S = evaluation impossible due to severe opacity
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- It was concluded that the test substance is severely irritating to rabbit eyes.
- Executive summary:
The eye irritant potential of Bardap 26 was evaluated in 3 New Zealand White rabbits. The rabbits received a single intraocular application of 0.1 ml of the test substance, reactions were evaluated at 1 and 6 hours post-instillation.
At 1 and 6 hours post-instillation, the eyes were half closed, corneal opacity, conjunctival swelling (chemosis) and a clear discharge were seen in all rabbits. Swelling precluded assessment of the iris and conjunctival redness. It was concluded that the test substance is severely irritating to rabbit eyes, and meets the classification criteria for Irreversible Effects on the Eye (Category 1) according to Regulation (EC) No. 1272/2008. The substance is already classified as Skin Corrosion Category 1B with hazard statement H314: Causes severe skin burns and eye damage, therefore additional classification as Irreversible Effects on the Eye (Category 1) with hazard statement H318 is already covered.
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