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EC number: - | CAS number: -
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Study not GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- N,N,N-trimethyl-C12-14 (even numbered)-alkyl-1-aminium chloride
- Molecular formula:
- C15H34Cl1N1 (representative molecular formula of C12 chain)
- IUPAC Name:
- N,N,N-trimethyl-C12-14 (even numbered)-alkyl-1-aminium chloride
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Dihydrogen oxide
- Test material form:
- liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Präpagen 2916 (Hoe S 2916)
- Composition: ca. 40% C12-14 alkylmethylammonium chloride, ca. 1% amine/aminehydrochloride with mentioned C chain, ca. 1% salt, ca. 60% water
- Form: Clear liquid
- Storage: in the dark at 2°C
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, conventional breeding
- Weight at study initiation: 2.2 - 2.5 kg
- Housing: individual cages in climatised room
- Diet (e.g. ad libitum): ERKA Z 6000 (Robert Koch oHG, Germany)
- Water (e.g. ad libitum): deinosed chlorinated water
Lighting: 12 h daily
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
Test system
- Controls:
- other: Untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1 ml
- Concentration (if solution): undiluted
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 7 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological saline at 37°C
- Time after start of exposure: 24 h
SCORING SYSTEM: as per OECD guideline
TOOL USED TO ASSESS SCORE: biomicroscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 2.1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 d
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 d
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 2.1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 d
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- (swelling)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 3.2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 d
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritant / corrosive response data:
- Corneal opacity was observed in all animals at the 1 h time point and was still present after 7 d when vascularisation of the cornea was also seen in 2/3 rabbits. Effects on the iris appeared after 1 h and increased in intensity until the 7 d timepoint when they were still scored at 2 in all rabbits. Conjunctival redness and swelling was also present from 1 h to the end of the study, with no reversibility of the symptoms. After 7 d, the nictating membrane was milky in all treated eyes. There was also bleeding of the conjunctiva and hair loss in a large area around the eyes.
Any other information on results incl. tables
Individual results are presented in the attachment entitled 'Präpagen eye irritation'.
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 1 (irreversible effects on the eye) based on CLP criteria
- Conclusions:
- Under the study conditions, the test substance was considered to be severely irritating to eyes.
- Executive summary:
A study was conducted to determine the eye irritation potential of the test substance, C12-14 TMAC (active ingredient 40%) in rabbit, according to OECD 405 Guideline. Three New Zealand White rabbits were exposed to undiluted substance (i.e., 40% test substance) applied as a 0.1 mL drop in the left conjunctival sack. The right eye was untreated and served as control. After 24 h of exposure, the eyes were gently washed with physiological saline solution at 37°C. Observations for corneal opacity, effects on the iris and conjunctival reddening/swelling were made 1, 4, 24, 48 and 72 h after eye washing, then after 7 d. Corneal opacity was observed in all animals at the 1 h time point and was still present after 7 d when vascularisation of the cornea was also seen in 2/3 rabbits. Effects on the iris appeared after 1 h and increased in intensity until the 7 d timepoint when they were still scored at 2 in all rabbits. Conjunctival redness and swelling was also present from 1 h to the end of the study, with no reversibility of the symptoms. After 7 d, the nictating membrane was milky in all treated eyes. There was also bleeding of the conjunctiva and hair loss in a large area around the eyes. Under the study conditions, the test substance was considered to be severely irritating to eyes (Jung and Weigand, 1982).
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