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EC number: 700-596-9 | CAS number: 14442-94-5
- 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
- Study period:
- 29 November to 09 December 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study undertaken in a GLP accredited laboratory to internationally recognised gudelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- T-1215A
- IUPAC Name:
- T-1215A
- Reference substance name:
- 3-(3,5-di-tert-butyl-4-hydroxyphenyl)-N-octadecylpropanamide
- EC Number:
- 700-596-9
- Cas Number:
- 14442-94-5
- Molecular formula:
- C35H63NO2
- IUPAC Name:
- 3-(3,5-di-tert-butyl-4-hydroxyphenyl)-N-octadecylpropanamide
- Reference substance name:
- 3-{3,5-Di-tert-butyl-4-hydroxyphenyl}-N-octadecyl-propionamide
- IUPAC Name:
- 3-{3,5-Di-tert-butyl-4-hydroxyphenyl}-N-octadecyl-propionamide
- Details on test material:
- - Name of test material (as cited in study report): T-1215A (3-(3,5-Di-tert-butyl-4-hydroxyphenyl)-N-octadecyl-propionamide)
- Substance type: Solid
- Physical state: Powder
- Analytical purity: 97.1% (measured by GC)
- Impurities (identity and concentrations):
3-(3,5-Di-tert-butyl-4-hydroxyphenyl)-N-hexadecyl-propionamide; 1.3%
3-(3,5-Di-tert-butyl-4-hydroxyphenyl)-N-heptadecyl-propionamide; 1.6%
- Purity test date: 28 October 2004
- Lot/batch No.: 04HY1101
- Stability under test conditions:
- Storage condition of test material: Room temperature in the dark
- Other:
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Commercial laboratory animal supplier.
- Age at study initiation: Twelve to twenty weeks
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: The animals were individually housed in suspended metal cages.
- Diet: Certified Rabbit Diet (Code 5322), ad libitum.
- Water: ad libitum
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30 to 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): Twelve hours continuous light, 0600h to 1800h and 12 hours dark.
IN-LIFE DATES: From: To:
Test system
- Vehicle:
- water
- Controls:
- other: The left eye remained untreated and was used for control purposes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 29 mg
- Concentration (if solution): 10% w/w aqueous preparation
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of treatment / exposure:
- Irnmediately after administration of the test material, an assessment of the initial pain reaction was made.
- Observation period (in vivo):
- 1, 24 48 and 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data.
- Time after start of exposure: 1, 24, 48 and 72 hours.
SCORING SYSTEM:Draize scale for scoring ocular irritation and a modified Kay and Calandra interpretation of the eye irritation test.
TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 1 hour
- Score:
- 6
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours of dosing
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24 hours
- Score:
- 2
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours of dosing
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not fully reversible within: 48 hours of dosing
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not fully reversible within: 48 hours of dosing
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 1 hour
- Score:
- 6
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours of dosing
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24 hours
- Score:
- 4
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours of dosing
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48 hours of dosing
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48 hours of dosing
- Irritant / corrosive response data:
- Initial Pain Reaction (IPR), will be graded as follows:
Class Reaction by Animal Descriptive Rating
0 No response No initial pain
1 A few blinks only, normal within one or twominutes Practically no initial pain
2 Rabbit blinks and tries to open eye, but reflex closes it Slight initial pain
3 Rabbit holds eye shut and puts pressure on lids, may rub eye with paw Moderate initial pain
4 Rabbit holds eye shut vigorously, may squeal Severe initial pain
5 Rabbit holds eye shut vigorously, may squeal, claw at eye, jump and try to escape Very severe initial pain
There is often no correlation between the initial pain and the subsequent eye irritation.
All three rabbits had an IPR of 2.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced a maximum group mean score of 4.0 and was classified as a minimal irritant (Class 3 on a I to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. Consequently this substance is not classified for eye irritation.
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