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EC number: 939-579-8 | 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:
- 23 October - 13 November 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non-GLP study conducted in compliance with OECD Guideline 405 with deviations: age at study initiation and individual animal weights not reported; environmental conditions not reported.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- age at study initiation and individual animal weights not reported; environmental conditions not reported
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
Test material
- Reference substance name:
- Reaction mass of sodium 3-{[3-(diethylamino)propyl]carbamoyl}-2-(dodecylamino)propanoate and sodium 3-{[3-(diethylamino)propyl]carbamoyl}-3-(dodecylamino)propanoate
- EC Number:
- 939-579-8
- Molecular formula:
- Empirical Formula : C11H21N3O3Na C2nH4n+1 (n=4 – 9), C11H21N3O3NaC18H35, C11H21N3O3NaC18H33 Molecular formula of the two main constituents : C23H46N3O3Na
- IUPAC Name:
- Reaction mass of sodium 3-{[3-(diethylamino)propyl]carbamoyl}-2-(dodecylamino)propanoate and sodium 3-{[3-(diethylamino)propyl]carbamoyl}-3-(dodecylamino)propanoate
- Details on test material:
- - Name of test material (as cited in study report): Chimexane HB
- Physical state: Translucent pale yellow gel
- Lot/batch No.: M 405
- Date received: 09 October 1995
- Storage condition of test material: Room temperature, away from the light and heat
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: elevage BERTHO, Yffiniac, France
- Weight at study initiation: 2.4 kg (mean)
- Housing: Animals were housed individually on floor grid.
- Diet: Complete pelleted rabbit maintenance diet Energie H326 (COFNA, Tours, France), ad libitum
- Acclimation period: 5 days
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
- Concentration (if solution): Undiluted test item - Duration of treatment / exposure:
- No washing was done.
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: No
SCORING SYSTEM: According to OECD Guideline 405
TOOL USED TO ASSESS SCORE:
- Ocular reactions were performed with a U. V. and white magnification light. After recording the observations at 24 h, the eyes of all rabbits were examined with the aid of fluorescein.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- - One hour after instillation of the substance, important irritation reactions were noticed in all animals, at the level of the conjunctivae (diffuse beefy red enanthemae, abundant discharge, chemosis with lids about half closed). Iris congestion was also observed.
- 24 h later, chemosis increased in two rabbits and a distinct corneal opacity was visible in three rabbits. All irritation phenomena regressed very slowly. Within about a week they disappeared in two animals.
- Irritation signs persisted in one animal at the end of the observation period (21 days) - Other effects:
- No data
Any other information on results incl. tables
Table 7.3.2/1: Results of eye irritation
Animal no. |
4615 |
4640 |
4641 |
|||||||||||||||
|
Conjunctiva |
Iris |
Cornea |
Conjunctiva |
Iris |
Cornea |
Conjunctiva |
Iris |
Cornea |
|||||||||
|
A |
B |
C |
D |
E |
F |
A |
B |
C |
D |
E |
F |
A |
B |
C |
D |
E |
F |
D1 (1 h) |
3 |
3 |
3 |
1 |
0 |
0 |
3 |
3 |
3 |
1 |
0 |
0 |
3 |
3 |
3 |
1 |
0 |
0 |
24 h |
4 |
3 |
3 |
1 |
2 |
4 |
4 |
3 |
3 |
1 |
2 |
3 |
3 |
2 |
3 |
1 |
2 |
2 |
48 h |
4 |
3 |
3 |
1 |
2 |
2 |
3 |
2 |
3 |
1 |
2 |
2 |
2 |
1 |
3 |
1 |
2 |
1 |
72 h |
4 |
2 |
3 |
1 |
2 |
2 |
3 |
2 |
3 |
1 |
1 |
1 |
1 |
1 |
3 |
1 |
2 |
1 |
M |
4.0 |
2.7 |
3.0 |
1.0 |
2.0 |
2.7 |
3.3 |
2.3 |
3.0 |
1.0 |
1.7 |
2.0 |
2.0 |
1.3 |
3.0 |
1.0 |
2.0 |
1.3 |
D5 |
3 |
1 |
3 |
1 |
4 |
2 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
2 |
1 |
D6 |
2 |
1 |
2 |
1 |
3 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
D7 |
2 |
1 |
2 |
1 |
2 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
D8 |
1 |
1 |
2 |
1 |
2 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
D9 |
1 |
1 |
2 |
1 |
2 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
D10 |
1 |
1 |
2 |
1 |
2 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
D11 |
1 |
1 |
3 |
1 |
2 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
D12 |
3 |
1 |
3 |
1 |
2 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
D13 |
3 |
1 |
3 |
1 |
2 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
D14 |
3 |
1 |
3 |
1 |
2 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
D15 |
3 |
1 |
3 |
1 |
2 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
D16 |
3 |
1 |
3 |
1 |
2 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
D17 |
3 |
1 |
3 |
1 |
2 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
D18 |
3 |
1 |
3 |
1 |
2 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
D19 |
3 |
2 |
3 |
1 |
2 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
D20 |
3 |
1 |
3 |
1 |
2 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
D21 |
1 |
1 |
2 |
0 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
D22 |
1 |
1 |
2 |
0 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
A: Chemosis; B: Discharge; C: Redness; D: Iris lesion; E: Opacity; F: Opacity area; M: Mean
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, Chimexane HB is classified as “R36 irritating to eyes”, according to the Annex VI of the Directive 67/548/EEC and ‘Category 1’ according to the Regulation (EC) N° 1272-2008 (CLP).
- Executive summary:
In a non-GLP eye irritation study conducted according to the OECD Guideline 405, 3 healthy male rabbits of the New Zealand White strain were exposed to 0.1 mL of undiluted test item Chimexane HB in their right eye while the left eye remained untreated and served as control. The eyelids were then gently held together for about one second to avoid any loss of test item. At 24 h after treatment, fluorescein solution was instilled into the eyes and they were examined under UV-lamp to detect possible corneal damage. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h and up to Day 22 after treatment and graded according to the method of OECD Guideline 405.
One hour after tiest item instillation, irritations of the palpebral and bulbar conjunctivae (enanthemae, discharge and chemosis) and iris congestion were noticed. 24 h later, chemosis increased in two rabbits and a distinct corneal opacity was visible in three rabbits. All irritation phenomena regressed very slowly. Within about a week they disappeared in 2 animals. Irritation signs persisted in one animal at the end of the observation period (21 days). Mean individual scores for the three animals at 24, 48 and 72 h post instillation were 2.0, 1.7, 2.0 for cornea score; 1.0, 1.0, 1.0 for iris score; 3.0, 3.0, 3.0 for conjunctivae score and 4.0, 3.3, 2.0 for chemosis score. In this study, Chimexane HB is an eye irritant on male rabbits.
Under the test conditions, Chimexane HB is classified as “R36 irritating to eyes”, according to the Annex VI of the Directive 67/548/EEC and ‘Category 1’ according to the Regulation (EC) N° 1272-2008 (CLP).
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