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EC number: 293-878-1 | CAS number: 91648-19-0
- 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:
- 25 May 1995 to 28 July 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- 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:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-C12-14 acyl derivs., hydroxides, inner salts
- EC Number:
- 293-878-1
- EC Name:
- 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-C12-14 acyl derivs., hydroxides, inner salts
- Cas Number:
- 91648-19-0
- IUPAC Name:
- 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-C12-14 acyl derivs., hydroxides, inner salts
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Betadet SHR
Lot number: 7049
pH 7.48
Appearance: viscous yellowish liquid
Storage: Room temperature protected from light
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Three New Zealand White male rabbits were used.
Weight on receipt: 2.0-2.2 kg
Age on receipt: approximately 9-10 weeks
Source: B and K Universal G.J., S.L.
Housing: Individually in stainless steel cages with a grill floor
Acclimatisation period: seven days
Weight at administration of test substance: 2.2-2.4 kg
Temperature: 18-22 degrees C
Humidity: 50-85%
Photoperiod: 12 hour dark/light cycle
Diet: Standard rabbit diet UAR 112, supplied by PANLAB, S. L., ad libitum
Water: Supplied by Compañia de Aguas de Sabadell, ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 21 days after treatment
- Duration of post- treatment incubation (in vitro):
- .
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- Following administration of the test substance, the eyelids were held closed for approximately 10 seconds. The behaviour of the animals was observed following instillation of the test substance. The animals were then returned to their cages.
The degree of eye irritation as evaluated for each rabbit at 1, 24, 48 and 72 hours after treatment. Additional observations were made on Days 7, 14 and 21 after treatment to check the reversibility of the reactions.
Observations were made after applying 2% aqueous sodium fluorescein to test the area and washing with physiological saline, with the exception of the 1 hour observations. Corneal alterations were made with the aid of a transilluminator with a cobalt blue filter.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.78
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.89
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks:
- Reversible in two rabbits; findings persisted (grade 1) to 21 days in one rabbit
Any other information on results incl. tables
Eye irritation scores
|
60 minutes |
24 hours |
48 hours |
72 hours |
Mean (24-72 hours) |
7 days |
14 days |
21 days |
Cornea |
0,0,0 |
1,1,1 |
1,1,1 |
1,1,1 |
1.00 |
1,0,0 |
1,0,0 |
0,0,0 |
Iris |
1,1,1 |
1,1,1 |
1,1,1 |
1,1,1 |
1.00 |
1,1,0 |
0,0,0 |
0,0,0 |
Erythema |
3,2,2 |
3,3,3 |
3,3,3 |
2,3,2 |
2.78 |
1,2,1 |
0,1,1 |
0,0,0 |
Chemosis |
2,3,2 |
2,3,2 |
1,2,2 |
1,2,2 |
1.89 |
1,1,1 |
1,0,1 |
0,0,1 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Instillation of the submission substance into the eyes of three rabbits caused marked eye irritation (corneal opacity, iridial infllammation, conjunctival erythema and chemosis). Irritation was reversible in two rabbits but persisted (grade 1 conjunctival chemosis only) in one rabbit at 21 days.
- Executive summary:
The submission substance Betadet SHR was instilled (0.1 mL) into one eye of three New Zealand White rabbits in accordance with OECD TG 405. Ocular irritation was scored for up to 21 days after instillation, using the Draize scale. Signs of irritation included corneal opacity (Grade 1 in all animals, fully reversible by 21 days); iridial inflammation (Grade 1 in all animals, fully reversible by 14 days); conjunctival erythema (Grade 3 in all animals, fully reversible by Day 21); and conjunctival chemosis (Grade 2-3). Grade 1 conjunctival chemosis persisted in one rabbit at 21 days. The mean scores for corneal opacity (mean score ≥1), iridial inflammation (mean score ≥1) and conjunctival erythema (mean score ≥2) result in classification of the substance as a Category 2 eye irritant according to the CLP Regulation; however the lack of complete reversibility of conjunctival chemosis in one rabbit at 21 days triggers classification in Category 1.
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