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EC number: 629-757-0 | CAS number: 1224966-15-7
- 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: Berolamine 715. Guideline, GLP principles
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Remarks:
- According to GLP principles (Statement SD, QA audit)
Test material
- Reference substance name:
- Fatty acids, C18 unsaturated, reaction product with ammonia-ethanolamine reaction by-products
- EC Number:
- 629-757-0
- Cas Number:
- 1224966-15-7
- Molecular formula:
- UVCB, no structural formula can be set
- IUPAC Name:
- Fatty acids, C18 unsaturated, reaction product with ammonia-ethanolamine reaction by-products
- Details on test material:
- The test material was in the form of a dark brown viscous liquid and was stored in the dark under ambient conditions. The pH value for the test substance was 11.2.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Cheshire Rabbit Farms
- Age at study initiation: no data
- Weight at study initiation: 2.5-3.0 kg
- Housing: housed individually in cages with a grid floor beneath which was a peat moss filled tray.
- Diet (e.g. ad libitum): Special Diet Services Standard Rabbit Diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 (15-19)
- Humidity (%): 46 (30-60)
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: no data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml - Duration of treatment / exposure:
- Single intillation, no flushing.
- Observation period (in vivo):
- The eyes were examined for irritation using standard illumination, unable to use fluorescein stain due to severe chemosis. The ocular reaction was recorded at one and 24 h at 24h it was decided to sacrifice the animals due to the severity of the observed effects.
- Number of animals or in vitro replicates:
- 3 male and 3 female animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
SCORING SYSTEM: as described in OECD405
TOOL USED TO ASSESS SCORE: standard illumination, unable to use fluorescein stain due to severe chemosis
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Time point:
- other: 24h
- Score:
- > 2 - < 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- animals were killed after 24h for humane reasons
- Irritant / corrosive response data:
- Cornea
Dullness of the cornea was noted in all treated eyes 1 h and 24 h after instillation. Severe chemosis prevented the use of fluorescein stain to
assess opacity although it was noted that no obvious opacity was apparent.
Iris
Positive iridial responses (score 1-2) were noted in one treated eye at 1 h, and in all treated eyes at 24 h after instillation.
Conjunctivae
Redness
Positive redness (score 2) was noted in 5/6 treated eyes and the remaining animal showed slight redness (score 1) at 1 h post instillation. All treated eyes showed positive responses (score 2) at 24h.
Chemosis
Severe chemosis (score 3-4) was noted in all treated eyes at 1 h and 24 h.
Discharge
Moderate discharge was noted in all treated eyes at 1 h post instillation. Severe thick white discharge was noted in all treated eyes at 24 h.
No other non-ocular topical effects were noted at any time during the test.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The test substance was extremely irritant to the eye in the rabbit irritation test. The test was terminated after 24h for humane reasons.
- Executive summary:
The test substance was extremely irritant to the eyes of 3 male and 3 female rabbits after single instillation of 0.1 ml. The test was terminated after 24h for humane reasons.
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