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Diss Factsheets
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EC number: 627-034-4 | CAS number: 1213789-63-9
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- From 1 March 1995 to 20 July 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study according to GLP
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Amines, hydrogenated tallow alkyl
- EC Number:
- 262-976-6
- EC Name:
- Amines, hydrogenated tallow alkyl
- Cas Number:
- 61788-45-2
- IUPAC Name:
- 61788-45-2
- Reference substance name:
- Hydrogenated Tallow Alkylamines
- IUPAC Name:
- Hydrogenated Tallow Alkylamines
- Details on test material:
- - Name of test material (as cited in study report): Farmin TH
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: B&K UNIVERSAL G.J., S.L
- Age at study initiation: 9-10 weeks
- Weight at study initiation: 2.3-2.5
- Housing: were individually in stainless steel cages with a grille floor
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21
- Humidity (%): 45-66
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated left eye was used as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg/animal - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 hours as well as 7, 14 and 21 days post exposure
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The observation of the cornea was completed with the installation of an aqueous solution of 2% sodium fluorescein. This procedure involved the installation of the aqueous solution of fluorescein in the test area, followed by washing the area with a 0.9% physiological saline solution.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h / 48h / 72h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: exposure 24 hours
- Irritation parameter:
- iris score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h / 48h / 72h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: exposure 24 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h / 48h / 72h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: exposure 24 hours
- Irritation parameter:
- chemosis score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 3.11
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: exposure 24 hours
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the findings of this study, the test material Farmin TH is considered to be severely irritating to eyes.
- Executive summary:
In an GLP compliant OECD TG 405 study, 100 mg the test substance Farmin TH (hydrogenated tallow alkyl amine), a white solid (pH = 9.93, purity 95%), was applied to the eyes of three New Zealand White rabbits. Pronounced conjunctiva redness and chemosis was observed throughout the entire observation period. Additionally, severe cornea opacity and moderate iris lesions was noted. Mean Draize scores for conjunctiva redness at 24, 48 and 72 hours were 3.0, 3.0 and 3.0. Mean scores for conjunctiva chemosis were 3.0, 3.0 and 3.3 for the same time points. These effects were not reversible within the observation period of 21 days. Related scores for iris were 1.0, 1.0 and 1.0, reversible between 14 and 21 days. Scores for cornea density were 3.0, 3.3 and 3.7, respectively and showed a value of 2.0 at the end of the observation period. Based on the findings of this study, the test material Farmin TH is considered to be severely irritating to eyes.
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