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EC number: 265-449-9 | CAS number: 65113-55-5
- 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:
- From 2012-06-25 to 2012-07-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- [4-[p,p'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium m-[[p-anilinophenyl]azo]benzenesulphonate
- EC Number:
- 265-449-9
- EC Name:
- [4-[p,p'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium m-[[p-anilinophenyl]azo]benzenesulphonate
- Cas Number:
- 65113-55-5
- Molecular formula:
- C25H30N3.C18H14N3O3S
- IUPAC Name:
- [4-[p,p'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium m-[[p-anilinophenyl]azo]benzenesulphonate
- Test material form:
- solid: particulate/powder
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 de Gérome (Quartier Labaste - F40260 Linxe)
- Age at study initiation: 13 weeks old
- Weight at study initiation: 2.90 kg (beginning of the test) - 3.08 kg (end of the test)
- Housing: individual box installed in conventional aire conditioned animal husbandry
- Diet (e.g. ad libitum): SDS-C15, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): 10 to 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12h light/12g dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 24 hr
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 1 animal
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological rinse of the remaining test item
- Time after start of exposure: 1h
SCORING SYSTEM: Grading of Eye Reactions as displayed in the attached document titled "Solvent Black 46 - IO-OCDE-PH-12/0297 Scoring System".
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal: A2132
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: A2132
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: A2132
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal: A2132
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- the iris was not discernible at all reading times
- Irritant / corrosive response data:
- The test item leads to a non-reversible irritation
- Other effects:
- Blue coloration
White coloration of the upper membrane on day 7
Discharge with moistening of the eyelids and neighbouring hairs
Corneal neovascularization and corneal oedema
Iris not discernible at all reading times.
Any other information on results incl. tables
Total and Individual scores of ocular irritation
Observation time |
CONJUNCTIVAE |
IRIS |
CORNEA |
|||
Chemosis |
Discharge |
Redness |
Iris |
Degree of opacity |
Extend of opacity |
|
1 hour |
2 |
2 |
1 |
* |
0 |
0 |
24 hours |
3 |
2 |
2 |
* |
2 |
4 |
48 hours |
3 |
2 |
2 |
* |
2 |
4 |
72 hours |
3 |
1 |
2 |
* |
2 |
4 |
Day 7• |
3 |
1 |
2 |
* |
2 |
4 |
Day 14•• |
3 |
1 |
2 |
* |
2 |
4 |
Day 21•• |
3 |
2 |
0 |
* |
2 |
4 |
*Iris not discernible
•White coloration of the upper membrane
••Corneal neovascularization and corneal oedema
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Under the experimental conditions, the test item is classified as irritant category 1 (irreversible effects on the eye) according to the CLP regulation (EC) No. 1272/2008.
- Executive summary:
The test item was instilled as supplied, into the eye of one New Zealand rabbit at the dose of 0.1g. Remaining test item requiring a physiological rinse was noted one hour after the test item instillation. A blue coloration remained after rinsing. The experimental protocol was established on the basis of the official method as defined in the OECD guideline No. 405 dated April 24th, 2002 and the test method B.5 of the council regulation No. 440/2008.
The ocular reactions observed during the study have been slight to important and partially reversible:
- at the conjunctivae level: a slight redness noted 1 hour after the test item instillation, turning into a moderate redness 24 hours after the test item instillation and totally reversible on day 21, associated with a moderate chemosis noted 1 hour after the test item instillation, turning into an important chemosis 24 hours after the test item instillation and remaining on day 21 (last day of the test, same intensity).
-at the corneal level: a moderate corneal opacity, noted 24 hours after the test item instillation and remaining on day 21 (same intensity).
The iris was not discernible whatever the reading time.
A white coloration of the upper membre was noted on day 7.
A corneal neovascularization and a corneal oedema were noted on day 14 and remained on day 21.
In conclusion, taking into account the irreversibility of lesions observed, the results obtained, under these experimental conditions, enable to conclude that the item must be classified R41 "Risk of serious damage to eyes", according to the criteria for the classification, packaging and labelling of dangerous substances in complicance with E.E.C Directives 67/548, 2001/59 and 99/45. It must be characterised by the symbol "Xi" and the danger label "irritant".
In accordance with the Regulation (EC) No. 1272/2008, the test item must be classified in category 1 "irreversible effects on the eye". The signal word "Danger" and hazard statement H318 "Causes serious eye damage" are required.
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