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EC number: 221-326-1 | CAS number: 3068-39-1
- 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:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Method according to the Federal Register 38 No. 187 § 1500.42 (eye)
- Version / remarks:
- 1973
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
Test material
- Reference substance name:
- 3,6-bis(ethylamino)-9-[2-(methoxycarbonyl)phenyl]-2,7-dimethylxanthylium chloride
- EC Number:
- 221-326-1
- EC Name:
- 3,6-bis(ethylamino)-9-[2-(methoxycarbonyl)phenyl]-2,7-dimethylxanthylium chloride
- Cas Number:
- 3068-39-1
- Molecular formula:
- C27H29N2O3.Cl
- IUPAC Name:
- 3,6-bis(ethylamino)-9-[2-(methoxycarbonyl)phenyl]-2,7-dimethylxanthylium chloride
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: Approximately 3 to 4 kg
- Housing: Animals were singly housed in a stainless steel cage without litter
- Diet: Standard pellet feed for rabbits provided ad libitum
- Water: ad libitum
- Acclimation period: >3 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Humidity: 55 ± 10 % (relative)
- Photoperiod: 12 hour light/12 hour dark cycle (07:00 to 19:00)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Observation period (in vivo):
- Animals were observed for signs of irritation and toxicity 1, 24, 48 and 72 hours after test material instillation and observations were continued for 7 days.
- Number of animals or in vitro replicates:
- 6 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No rinsing occurred
SCORING SYSTEM: Draize scale
CORNEA
Opacity: degree of density (area most dense is taken for reading)
0: No opacity
1: Scattered or diffuse areas of opacity, details of iris clearly visible
2: Easily discernible translucent area, details of iris slightly obscured
3: Opalescent area, no details of iris visible, size of pupil barely discernible
4: Opaque, iris invisible
IRIS
0: Normal
1: Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination of any thereof) still reacting to light (sluggish reaction is positive)
2: No reaction to light, haemorrhage, gross destruction (any of all these or all together)
CONJUNCTIVAE
Redness: (refers to the most severe effect of palpebral and bulbar conjunctivae excluding cornea and iris)
0: Vessels normal
1: Vessels definitely injected above normal
2: More diffuse, deeper crimson red, individual vessels not easily discernible
3: Diffuse beefy red
Chemosis
0: No swelling
1: Any swelling above normal (includes nictating membranes)
2: Obvious swelling with partial eversion of lids.
3: Swelling with lids about half closed
4: Swelling with lids about half closed to completely closed
Discharge
0: No discharge
1: Any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2: Discharge with moistening of the lids and hairs just adjacent to lids
3: Discharge with moistening of the lids and hairs a considerable area around the eye
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of all animals that could be scored
- Time point:
- 24/48/72 h
- Score:
- 3.9
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of all animals that could be scored
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Not possible to evaluate due to very strong swelling of cornea and iris
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of all animals
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- other:
- Remarks:
- discharge
- Basis:
- mean
- Remarks:
- of all animals
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- 1 hour post application, strong swelling of the conjunctivae with mild to severe oozing/ weeping of the eye was observed. Four rabbits were observed to have slight opacification of the cornea. From 24 hours post application until end of the observation period, the edges of the eyelids were strongly hardened with discharge for all rabbits. Eyes were initially covered in mucous, which later on became purulent and glued together. Any redness caused by the test material could not be determined due to extreme swelling of the eyes. After seven days post application, the observations were essentially the same as the observations after 72 hours.
Any other information on results incl. tables
Table 1: Individual Scores
Time Point (h) |
Rabbit number |
Evaluation |
||||
Cornea |
Iris |
Conjunctival redness |
Chemosis |
Discharge |
||
24 |
1 |
* |
* |
** |
4 |
3 |
2 |
* |
* |
** |
4 |
3 |
|
3 |
* |
* |
** |
4 |
3 |
|
4 |
* |
* |
** |
4 |
3 |
|
5 |
4 |
2 |
** |
4 |
3 |
|
6 |
3 |
2 |
** |
4 |
3 |
|
48 |
1 |
* |
* |
** |
4 |
3 |
2 |
* |
* |
** |
4 |
3 |
|
3 |
4 |
2 |
** |
4 |
3 |
|
4 |
4 |
2 |
** |
4 |
2 |
|
5 |
4 |
2 |
** |
4 |
2 |
|
6 |
4 |
2 |
** |
4 |
2 |
|
72 |
1 |
* |
* |
** |
4 |
3 |
2 |
* |
* |
** |
4 |
3 |
|
3 |
4 |
2 |
** |
4 |
3 |
|
4 |
4 |
2 |
** |
4 |
3 |
|
5 |
4 |
2 |
** |
4 |
2 |
|
6 |
4 |
2 |
** |
4 |
1 |
*Assesment not possible due to staining of the eye as the test material is a red colour
**Not determined due to strong swelling of the cornea and iris
Applicant's summary and conclusion
- Interpretation of results:
- other: Requires classification as Category 1 in accordance with EU classification criteria
- Conclusions:
- Under the conditions of the study, the test material caused irreversible damage to the eyes and requires classification as Category 1.
- Executive summary:
The potential of the test material to cause eye irritation was investigated in the albino rabbit using the German method according to the Federal Register 38 No. 187 § 1500.42 (eye) which is equivalent to the standardised guideline OECD 405.
A single 100 mg quantity of the test material was applied to one eye in each of 6 rabbits and the untreated eye was used as a control. Animals were observed for signs of irritation and toxicity 1, 24, 48 and 72 hours after test material instillation.
1 hour post application, strong swelling of the conjunctivae with mild to severe oozing/ weeping of the eye was observed. Four rabbits were observed to have slight opacification of the cornea. From 24 hours post application until end of the observation period, the edges of the eyelids were strongly hardened with discharge for all rabbits. Eyes were initially covered in mucous, which later on became purulent and glued together. Any redness caused by the test material could not be determined due to extreme swelling of the eyes. After seven days post application, the observations were essentially the same as the observations after 72 hours.
Under the conditions of the study, the test material caused irreversible damage to the eyes and requires classification as Category 1.
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