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EC number: 909-125-3 | 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well conducted and documented study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: enforcement of the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR), the Toxic Substances Control Act (40 CFR)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- with the exception of the nurnber of animals employed for testing
- Principles of method if other than guideline:
- Due to the suspected irritation potential of this test material, a single animal was initiated on this primary eye irritation study.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hallcomid M-8-10
- IUPAC Name:
- Hallcomid M-8-10
- Reference substance name:
- Decanamide, N,N-dimethyl-, mixt. with N,N-dimethyloctanamide
- Cas Number:
- 67359-57-3
- IUPAC Name:
- Decanamide, N,N-dimethyl-, mixt. with N,N-dimethyloctanamide
- Details on test material:
- - Name of test material (as cited in study report):HALLCOMlD M-8-10
- Substance type: mixture of dimethylamides
- Physical state: liquid, clear, golden-tinted
- Stability under test conditions: stable at room temperature
- Storage condition of test material: room temperature
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:The animals were purchased from a U.S.D.A approved supplier
- Housing: Animals were housed slngly in wire mesh suspension cages
- Diet (e.g. ad libitum):PURINA LABORATORY RABBIT CHOW (or ether comparable diet), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 1 day
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12h each
Preparation of animals:
Within approximately twenty four hours of test material applieation, eyes will be examined using fluorescein dye. One drop of Fluorescein Sodium Ophthalmie Solution U.S.P. or equivalent will be applied directly to the cornea. After flushing out the excess fluorescein with Sodium Chloride Solution
U.S.P. or equivalent, the corneas will be visualized under ultraviolet illumination. Any anlmal exhibltlng pre-existing defects or irritation which could compromise the validity ot the study will not be used.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye serves as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml - Duration of treatment / exposure:
- 24h
- Observation period (in vivo):
- 1h, 24h, 48h, 72h and 4 days
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24h
SCORING SYSTEM: draize
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: average of 24h, 48h and 72h reading
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 4 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: average of 24h, 48h and 72h reading
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 4 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- erythema
- Basis:
- animal #1
- Time point:
- other: average of 24h, 48h and 72h reading
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: average of 24h, 48h and 72h reading
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 4 days
- Irritant / corrosive response data:
- The test material produced corneal opacity, iritis, and conjunctival irritation
persisting for the 4 day duration of this test.
No evidence of corrosion was noted in the animal.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU GHS
- Conclusions:
- Irreversible eye effects possible
- Executive summary:
The primary ocular irritancy of HALLCOMID M-8-10 was evaluated in compliance with the conditions specified in the regulation for the enforcement of the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR), the Toxic Substances Control Act (40 CFR), and the OECD Guidelines with the exception of the number of animals employed for testing. One New Zealand White rabbit was exposed to 0.1ml test substance and gradings were scored after 1h, 24h, 48h, 72h and 4 days. Due to the suspected irritation potential of this test material, a single animal was initiated on this primary eye irritation study. Due to the effects exhibited in this single animal, this study was ultimately terminated without testing in additional animals.
The test material produced corneal opacity, iritis, and conjunctival irritation persisting for the 4 day duration of this test when applied without rinsing to the eye of one New Zealand White rabbit. In addition, corneal vascularization becarne apparent at day 4.
Irritation scores in the one animal are: cornea score 1.7, iris score 1, conjunctivia 2.7 and chemosis 4.
No evidence of corrosion was noted in the animal.
Based on this result the substance has to be labelled as Cat 1 irreversible eye effects according to EU GHS EC 1272/2008.
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