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Reaction mass of 5,5'-{(phenylmethanediyl)bis[benzene-4,1-diyl-diazene-2,1-diyl]}bis{1-[3-(dimethylamino)propyl]-4-methyl-6-oxo-3-(pyridinium-1-yl)-1,6-dihydropyridin-2-olate} hydrochloride and 5,5’-[3,4’-(phenylmethanediyl)diphenylene]bis(diazene-2,1-diyl)bis{1-[3-(dimethylamino)propyl]-4-methyl-6-oxo-3-(pyridinium-1-yl)-1,6-dihydropyridin-2-olate} hydrochloride
EC number: 700-312-3 | 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2007-10-22 to 2008-01-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study under GLP without deviations, conducted with the analogue substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- analogue substance (refer to IUCLID chapter 13)
- IUPAC Name:
- analogue substance (refer to IUCLID chapter 13)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands BV, Kreuzelweg 53, NL-5961 NM Horst / The Netherlands, Postbus 6174, NL-5960 AD Horst / The Netherlands
- Age at study initiation: 13 weeks (male), 13 - 14 weeks (females)
- Weight at study initiation: First Day of Acclimatization: 2187, 2523, 2418 g; Last Day of Observation: 3021, 3411, 3444 g
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet (e.g. ad libitum): Pelleted standard rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): Community tap water ad libitum.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2007-10-24 To: 2007-11-20
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 21 days
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: The eye reactions were assessed according to the numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004 (study report page 30). Scleral reddening and ocular discharge were also assessed.
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- degree of corneal opacity
- Basis:
- mean
- Remarks:
- animals no. 1, 2, and 3
- Time point:
- other: overall at 24, 48, and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- other: staining not fully reversible within 21 days in one female,
- Remarks on result:
- other: One female with a very slight opacity of the cornea on day 21. Another test animal showed fully reversible reaction within 21 days, whereas the third test animal recovered fully within 7 days.
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animals no. 1, 2, and 3
- Time point:
- other: overall at 24, 48, and 72 h
- Score:
- 0.44
- Max. score:
- 2
- Reversibility:
- fully reversible within: 2 days or 7 days, respectively
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- animals no. 1, 2, and 3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days or 14 days, respectively
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animals no. 1, 2, and 3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- other: sclera
- Basis:
- mean
- Remarks:
- animals no. 1, 2, and 3
- Time point:
- other: overall at 24, 48, and 72 h
- Score:
- 1.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity were 1.00 for each of the three animals and for iris were 0.00, 1.00 and 0.33, respectively. The individual mean scores for the conjunctivae were 2.00 for reddening and 1.00 for chemosis, for each of the three animals.
One hour after instillation, the opacity of the cornea and the reddening of the conjunctivae as well as the sclerae of the three animals were not assessable due to a marked yellow staining produced by the test item. When assessable at the 24-hour reading, a very slight opacity of the cornea affecting the whole area was observed in all animals. The opacity persisted up to day 10 and 21, respectively affecting more than one quarter or more than half of the cornea and was due to the staining caused by the test item. The iris of both females showed a delayed / reduced light reflex at the 24-hour observation up to the 72-hour reading in one female. Additionally, a moderate reddening of the conjunctivae was noted in all animals 24 hours after treatment and persisted as slight up to day 7 or 10, respectively. An obvious swelling with partial eversion of the lids was recorded in the three animals at the 1-hour observation and persisted as slight swelling up to the 72-hour evaluation. Furthermore, a slight to moderate reddening of the sclerae was present in the treated animals 24-72 hours after treatment.
Moderate ocular discharge was noted in all animals 1 hour after instillation and persisted as slight discharge up to the 72-hour observation.
No abnormal findings were observed in the treated eye of two animals 10 and 21 days after treatment, respectively. One female was still observed with a very slight opacity affecting more than half of the cornea on day 21, i.e. one of three animals showed persistent corneal effect. - Other effects:
- MORTALITY/CLINICAL SIGNS: No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
COLORATION:
A marked yellow staining produced by the test item was observed in each animal one hour after instillation and persisted as slight up to day 21.
CORROSION:
No corrosion of the cornea was observed at any of the reading times. BODY WEIGHTS: The body weights of all rabbits were considered to be within the normal range of variability.
TEST ITEM REMNANTS:
Yellow test item remnants were evident in the eye or conjunctival sac of each animal 1 hour after treatment and persisted up to the 24- or 72-hour reading.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- One of three test animals showed a persistent corneal effect (i.e. staining) which triggers classification for eye damage. Given the applicability of the proposed read across approach (see IUCLID chapter 13) the same classification also apply to the substance registered.
- Executive summary:
The primary eye irritation potential of the analogue substance was being investigated following the testing protocol as given in OECD guideline 405.
The analogue substance was applied by instillation of 0.1 g into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7, 10, 14, 17 and 21 days after test item instillation.
The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity were 1.00 for all three animals and for iris were 0.00, 1.00 and 0.33, respectively. The individual mean scores for the conjunctivae were 2.00 for reddening and 1.00 for chemosis, for each of the three animals.
The instillation of the analogue substance into the eye resulted in mild to moderate, early-onset and transient ocular changes, such as very slight opacity of the cornea, delayed/reduced light reflex, reddening of the conjunctivae and sclerae, discharge and chemosis. These effects were reversible in two animals and were no longer evident at the latest 10 and 21 days after treatment, respectively. One female was still observed with a very slight opacity affecting more than half of the cornea on day 21, the end of the observation period. No corrosion was observed at any of the measuring intervals. A marked yellow staining of the treated eyes by the test item was observed which persisted as slight up to day 21, the end of the observation period. Yellow test item remnants were evident in the eye or conjunctival sac of each animal 1 hour after treatment and persisted up to the 24- or 72 hours. No clinical signs were observed.
One of three test animals showed a persistent corneal effect (i.e. staining) which triggers classification for eye damage. Given the applicability of the proposed read across approach (see IUCLID chapter 13) the same classification also apply to the substance registered.
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