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EC number: 454-210-6 | CAS number: 13106-24-6
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
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:
- -
- EC Number:
- 454-210-6
- EC Name:
- -
- Cas Number:
- 13106-24-6
- Molecular formula:
- C13 H30 N . C H3 O4 S
- IUPAC Name:
- tributyl(methyl)azanium methyl sulfate
- Details on test material:
- Substance Number: 97/272
Batch number: 601
Degree of purity: 101 g/100 g (H-NMR)
Physical state/appearance: Solid (congealed melt), white
Storage conditions: Room temperature.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Animals: New Zealand White (SPF)
Age: Young adult animals
Acclimatization period: At least one week.
Room temperature/relative humidity: The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20 - 24 degrees celsius for temperature and of 30-70 % relative humidity. There were no deviations from these ranges wgich influenced the results of the study.
Day/night rhythm: 12 h/12 h (6.00 A.M. - 6.00 P.M./6.00 P.M. - 6.00 A.M.)
Type of cage: Stainless steel wire mesh cages with grating, floor area 3000 cm2.
No. of animals per cage: Single housing.
Bedding: No bedding in the cages; sawdust in the waste trays.
Drinking water: About 250 ml tap water per animal per day.
Diet: Kliba-Labordiet, Klingentalmuehle AG, Kaiseraugst, Switzerland. About 130 g per animal per day.
Analysis of drinking water: The drinking water is regularly assayed for chemical contaminants by the municipal authorities of Frankenthal and the technical services of BASF Aktiengesellschaft as well as for the presence of germs by a contract laboratory.
Analysis of feed: The feed used in the study was assayed for chemical and microbiological contaminants.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 15 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Both eyes of the animals were examined before application of the test material for signs of pre-existing irritation, reaction or abnormality which would prevent it from being used in the study.
Acclimatization period: At least 1 week.
Weight determination: Shortly before application of the test substance.
Route of application: Single application to the conjunctival sac of the right eyelid. The substance was washed out with tap water about 24 hours after application (before 24 hour reading).
Application volume: 0.1 ml of the at about 80 degrees centigrade heated test substance. Before application it was cooled down to body temperature.
Observation period: 15 d.
Readings: 1 h, 24 h, 48 h, 72 h, 8 d, and 15 d after application.
Mortality: A check for any dead or moribund animal was made twice each workday and once on saturdays, sundays, and on public holidays.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24-48-72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 15 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 15 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24-48-72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 15 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24-48-72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 d
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 0.2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 2.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 15 d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 1.2
- Reversibility:
- fully reversible within: 15 d
- Irritant / corrosive response data:
- No effects on the cornea were observed.
In one animal an effect on the iris after 24 h and 48 h after application was observed, which was fully reversible within 72 h.
Conjunctivae redness was markedly increased from 1 h to 8 d after application in all 3 animals. These effects were fully reversible within 15 d.
Chemosis was observed in all 3 animals after 1 h and 24 h.Between 48 h and 72 only 2 animals showed chemosis. After 15 d no chemosis was observed in any animal. Discharge was observed in all animals between 1 h and 72 h. After 8 day discharge was only seen in 1 animal which also suffered from suppuration. After 15 d discharge was fully reversible in all animals and also suppuration of one animal was reversible.
Details see table 1.
Any other information on results incl. tables
Table 1: Irritation/Corrosion scores after treatment of animals with test substance.
Readings | Animal | Cornea-opacity | Cornea-area | Iris | Conjunctiva-Red | Conjunctiva-swelling | Conjunctiva-discharge |
1 h | 01 | 0 | 0 | 0 | 2 | 1 | 3 |
02 | 0 | 0 | 0 | 2 | 2 | 3 | |
03 | 0 | 0 | 0 | 2 | 2 | 2 | |
24 h | 01 | 0 | 0 | 0 | 3 | 2 | 2 |
02 | 0 | 0 | 0 | 3 | 1 | 1 | |
03 | 0 | 0 | 1 | 3 | 2 | 3 | |
48 h | 01 | 0 | 0 | 0 | 2 | 1 | 1 |
02 | 0 | 0 | 0 | 3 | 0 | 1 | |
03 | 0 | 0 | 1 | 3 | 2 | 3 | |
72 h | 01 | 0 | 0 | 0 | 2 | 1 | 1 |
02 | 0 | 0 | 0 | 2 | 0 | 1 | |
03 | 0 | 0 | 0 | 2 | 2 | 1 | |
8 d | 01 | 0 | 0 | 0 | 1 | 0 | 1 |
02 | 0 | 0 | 0 | 1 | 0 | 0 | |
03 | 0 | 0 | 0 | 1 | 1 | 0 | |
15 d | 01 | 0 | 0 | 0 | 0 | 0 | 0 |
02 | 0 | 0 | 0 | 0 | 0 | 0 | |
03 | 0 | 0 | 0 | 0 | 0 | 0 | |
Mean | 01 | 0.0 | 0.0 | 2.3 | 1.3 | ||
02 | 0.0 | 0.0 | 2.7 | 0.3 | |||
03 | 0.0 | 0.7 | 2.7 | 2.0 | |||
Mean | 0.0 | 0.2 | 2.6 | 1.2 |
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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