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EC number: 944-209-3 | 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:
- key study
- Study period:
- June/July 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study but information on purity and composition of the test substance is not given.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- the eyes of three/six animals were rinsed 4 seconds p.a.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- EEC directive 84/449/EEC, September 19, 1984
- Deviations:
- yes
- Remarks:
- the eyes of three/six animals were rinsed 4 seconds p.a.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Amides, C8-18 even numbered, N-[3-(dimethylamino)propyl]
- EC Number:
- 930-947-3
- IUPAC Name:
- Amides, C8-18 even numbered, N-[3-(dimethylamino)propyl]
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harald Schriever; Kaninchenfarm D-2740 Bremervörde
- Age at study initiation: no data
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: individual housing (cage size: 40 cm high, 45 cm wide, 50 cm long) in a battery of cages, each equipped with a paper roll disposal system
- Diet: ad libitum, standard laboratory rabbit diet Ssniff Mü Z
- Water: ad libitum, aqua fontana as for human consumption
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 2
- Humidity (%): 50 - 85
- Air changes (per hr): no data
- Photoperiod: fluorescent light (120 lux) 12 hours daily from 7.00 a.m. - 7.00 p.m
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Each animal served as its one control. The test article was introduced into the conjunctival sac of one eye, the untreated eye serving as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g
- Concentration: undiluted
- Preparation of the test substance: The test substance was applied fine ground. - Duration of treatment / exposure:
- Eyes of 3 animals were rinsed 4 seconds p.a., the eyes of the other tree animals were not rinsed after treatment.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- On animal 4- 6 the treated eye was washed out 4 sec. p.a. with 10 mL lukewarm water.
-- Time after start of exposure: 4 seconds
SCORING SYSTEM: Draize Scheme as stipulated by OECD 405
TOOL USED TO ASSESS SCORE: Readings of ocular reactions were made 1 h, 24 h, 48 h, 72 h after treatment. Besides the eyes were examined for potential eye lesions 24 h and 72 h p.a. by means of 1 % fluorescein-dilution(1 drop/eye).
It was washed out about 60 sec. p.a. with sterile, non-pyrogenic, physiol. saline.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #4; #5; #6
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: eyes rinsed
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: eyes rinsed
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- within 72 hours
- Remarks on result:
- other: eyes rinsed
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- within 72 hours
- Remarks on result:
- other: eyes rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 72 hours
- Remarks on result:
- other: eyes rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 72 hours
- Remarks on result:
- other: eyes rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 72 hours
- Remarks on result:
- other: eyes rinsed
- Irritation parameter:
- chemosis score
- Basis:
- animal: #4, #5
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 72 hours
- Remarks on result:
- other: eyes rinsed
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 72 hours
- Remarks on result:
- other: eyes rinsed
- Irritant / corrosive response data:
- CLINICAL EYE OBSERVATION
- In unrinsed eyes severe eye reactions were seen at the 60 minutes and the 24 hour scoring:
-- Cornea scores of 0 or 1
-- Iris scores of 1 or 2
-- Conjunctivae redness scores of 2 or 3
-- Conjunctivae chemosis scores of 3 or 4
Due to the severe reactions these animals were killed after the 24 hour scoring.
In eyes rinsed 4 seconds p.a. the test substance was irritating.
-- Cornea scores of 0
-- Iris scores of 0 or 1
-- Conjunctivae redness scores of 2 or 3
-- Conjunctivae chemosis scores of 2 or 3
REVERSIBILITY: The observation time did not extend beyond 72 hours, even though severe eye responses were still present at these times, therefore, the reversibility of the eye effects cannot be evaluated.
Any other information on results incl. tables
Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
0/0/0/0/0/0 |
0/0/2/1/1/1 |
2/2/3//2/2/3 |
3/3/3/3/2/2 |
24 h |
1/0/1/0/0/0 |
2/0/2/2/1/1 |
3/2/3/3/2/3 |
4/4/4/2/2/3 |
48 h |
*/*/*/0/0/0 |
*/*/*/1/1/0 |
*/*/*/3/2/3 |
*/*7*/2/2/3 |
72 h |
*/*/*/0/0/0 |
*/*/*/1/1/0 |
*/*/*/2/2/3 |
*/*/*/2/2/2 |
Average 24h, 48h, 72h |
not calculated |
not calculated |
not calculated |
not calculated |
Area effected |
no data |
no data |
no data |
no data |
Maximum average score (including area affected, max 110) |
no data |
no data |
no data |
no data |
The eyes of animal 1 to 3 were unwashed, the eye of animal 4 to 6 were rinsed 4 seconds p.a
* = Due to the severe reactions these animals were killed after the 24h value
The observation time did not extend beyond 72 hours, even though severe eye responses were still present at these times, therefore, the reversibility of the eye effects cannot be evaluated.
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: CLP, EU GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- Interpretation is based on effects on the corneal opacity/iritis and conjunctival redness/chemosis calculated as mean scores following grading at 24, 48 and 72 hours after instillation of the test material in the rinsed eyes. The scores for corneal opacity are 0, for iritis are >= 1 and for conjunctival redness/chemosis >= 2. The observation time did not extend beyond 72 hours, even though severe eye responses were still present at these times, therefore, the reversibility of the eye effects cannot be evaluated.
Whereas an evaluation of the unwashed eyes was not possible because they were all killed 24 h p.a. due to the severe eye reactions.
The test substance Fettsäuredimethylaminopropylamid was judged to be irritating to the eye bases on the effects in the rinsed eye within 72 hours. An evaluation of the unwashed eyes was not possible. - Executive summary:
In a primary eye irritation study according to OECD Guideline 405 and EU Method B.5, 0.1 g of Amides, C8-18 even numbered, N-[3-(dimethylamino)propyl] was instilled into the conjunctival sac of six White New Zealand rabbits. The eyes of three animals were rinsed 4 seconds after substance application. Animals then were observed for 72 hours. Irritation was scored by the method of Draize as stipulated by OECD Guideline 405.
In unrinsed eyes severe eye reactions were seen at the 60 minutes and the 24 hour scoring:
-- Cornea scores of 0 or 1
-- Iris scores of 1 or 2
-- Conjunctivae redness scores of 2 or 3
-- Conjunctivae chemosis scores of 3 or 4.
Due to the severe reactions these animals were killed after the 24 hour scoring.
In eyes rinsed 4 seconds p.a. the test substance induced
-- Cornea scores of 0
-- Iris scores of 0 or 1
-- Conjunctivae redness scores of 2 or 3
-- Conjunctivae chemosis scores of 2 or 3
The observation time did not extend beyond 72 hours, even though severe eye responses were still present at these times, therefore, the reversibility of the eye effects cannot be evaluated.
The test substance was judged to be irritating to the eye based on the effects of the rinsed eye (washed out 4 secondes p.a.) within 72 hours.
Whereas an evaluation of the animals with unwashed eyes was not possible because they were killed 24 h p.a. due to the severe eye reactions.
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