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Diss Factsheets
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EC number: 825-246-3 | CAS number: 2098351-38-1
- 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:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 20 september 1993 - 4 october 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Read-across (Category)
The available in vivo data on this endpoint is consistent within the group. Two in vivo eye irritation studies are available on two of the substances. The effects seen, such as redness in conjunctiva and cornea, were reversible and mild, therefore not generating any classification. Using this data for read across within the group would be extrapolating data to the extremes of the group. In order to support this read across, in vitro eye irritation studies on all the four substances were performed, both in EpiOcular and Isolated Chicken Eye test. Also the in vitro tests results were consistent within the group, indicating a mild to irritating results. There is no possibility to evaluate the reversibility of the effects seen in in vitro studies. The in vitro tests EpiOcular and Isolated chicken eye tests are considered to over-predict the actual eye irritation potential of the substance shown in the rabbit tests. The effects in the in vitro studies are mild, and do not indicate Cat 1 classification for eye irritation. Currently in vivo data is required in order to classify eye irritation Cat 2. The weight of evidence from the available eye irritation data on this group of substances indicates no classification for eye irritation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Amines, N-C8-22-alkylpolytrimethylenepoly-, carboxymethyl derivs., sodium salts
- EC Number:
- 307-458-3
- EC Name:
- Amines, N-C8-22-alkylpolytrimethylenepoly-, carboxymethyl derivs., sodium salts
- Cas Number:
- 97659-53-5
- Details on test material:
- Identity: Ampholak 7CX
Chemical name: Cocoamphopolycarboxyglycinate
Ref No.: 19882,1458
Batch number: FP 91327
Expiry: 18 August 1995
Purity: 27% in water
Appearance: Clear amber liquid
Storage conditions: Room temperature
Date received: 18 August 1993
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Amount / concentration applied:
- 0.1 mL
- Observation period (in vivo):
- 24, 48, 72 h
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-48-72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24-48-72 hours
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A single instillation of the technical product into the eye of the rabbit elicited corneal opacificaton, iridial inflammation and well-defined conjunctival irritation. All reactions had resolved 3 or 7 days after instillation. The composition of the technical product is 40% active ingredient and 60 % water. The observed results do not warrant classification according to GHS.
- Executive summary:
A study was performed to assess the eye irritation potential of a technical product to the rabbit. The method followed was that described in EEC Methods for the determination of toxicity, Amex to Directive 92/69/EEC (OJ No. L383A, 29.12.92), Part 3, Method B.5. Acute toxicity (eye irritation). Three rabbits were each administered a single ocular dose of 0.1 ml of the test substance and observed for seven days after instillation. A single instillation of the technical product into the eye of the rabbit elicited corneal opacificaton, iridial inflammation and well-defined conjunctival irritation. All reactions had resolved 3 or 7 days after instillation. The observed results do not warrant classification according to GHS.
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