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EC number: 931-228-7 | 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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study based on national and scientific standards, basic data given, acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
- Reference Type:
- other: Summary report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- according to standard procedure, grading of effects based on the numerical scoring systems after Draize 1959
- GLP compliance:
- no
Test material
- Reference substance name:
- Amines, C12-18-alkyl
- EC Number:
- 268-953-7
- EC Name:
- Amines, C12-18-alkyl
- Cas Number:
- 68155-27-1
- Molecular formula:
- mixture of C13 [C13H29N] and C15 [C15H33N]-branched and linear amines
- IUPAC Name:
- Amines, C12-18-alkyl
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Synprolam 35 (trade name)
- Substance type: organic
- Physical state: liquid, clear
- Melting point: 12.5 °C
- Boiling point: 263 °C
- Density: 0.806 g/mL (20 °C)
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data in the Report
data adopted from the precursor aldehyde mixture (SYNPRAL 135):
- n-tridecylamine 33 % (m/m)
- isotridecylamine 33 % (m/m)
- n-pentyldecylamine 14 % (m/m)
- isopentylamine 14 % (m/m)
- other components 6 % (m/m)
[Reference: ICI 1975/1976: Synthetic fatty amines - Synpral 135 (Synprolaldehyde; C13/C15 alkyl aldehyde). MSDS]
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Huntingdon
- Housing: individually in metal cages
- Diet: ad libitum
- Water: ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- not rinsed
- Observation period (in vivo):
- 2 days
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: numerical scale according to Draize, Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Appendix 2, 1959.
The results were interpreted using a modification of the method recommended by Kay and Calandra, Journal of the Society of Cosmetic Chemists, 13 (6), 281-9, Appendix 3, 1962.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 1, 2, 3
- Time point:
- other: day 1 and 2
- Score:
- 110
- Max. score:
- 110
- Reversibility:
- not reversible
- Remarks on result:
- other: not quantitively evaluable / descriptive rating: very to extremely severe irritant
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the severity of the reactions the animals were all sacrificed on day 2.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the severity of the reactions the animals were all sacrificed on day 2.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the severity of the reactions the animals were all sacrificed on day 2.
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the severity of the reactions the animals were all sacrificed on day 2.
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the severity of the reactions the animals were all sacrificed on day 2.
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the severity of the reactions the animals were all sacrificed on day 2.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the severity of the reactions the animals were all sacrificed on day 2.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the severity of the reactions the animals were all sacrificed on day 2.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the severity of the reactions the animals were all sacrificed on day 2.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the severity of the reactions the animals were all sacrificed on day 2.
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the severity of the reactions the animals were all sacrificed on day 2.
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the severity of the reactions the animals were all sacrificed on day 2.
- Irritant / corrosive response data:
- Corneal damage in all animals, severe conjunctival swelling extending beyond the limits of the orbit, resulting in total eye closure.
No assessment of the degree of inflammation reaction possible.
All three animals had to be killed on day 2 for humane reasons.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- On instillation of the test item the animals showed moderate initial pain.
Corneal damage was produced in all three animal but assesment of the degree and extent was precluded by the severe conjuctival swelling. Considerable swelling of the conjuctivae extending well beyond the limits of the orbit resulting in complete closure of the eye was observed in all three rabbits. It was impossible to asses the degree of inflammation.
Due to the severity of the reactions the animals were all sacrificed on day 2. - Executive summary:
In an in vivo eye irritation study three albino rabbits of the New Zealand White strain were treated with 1 drop (0.1 mL) of the test substance per one eye.
The test item caused moderate to severe initial pain (3 -4 on a 5 point scale according to Kay and Calandra, 1962) which was followed by extremely severe irritation which was impossible to score. No readings could be taken if the iris and cornea due to swelling accomapnied by a great amount of discharge. Histopathological examination of sections of the eye 2 days after the installation showed the material to cause severe conjunctivitis, diffuse necrosis and inflammation of the anterior chamber.
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