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EC number: 278-575-4 | CAS number: 76918-62-2
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed GLP and OECD guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
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)
- Version / remarks:
- 84/449/EEC
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sodium N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxynaphthalene-2-carboxamidate
- EC Number:
- 278-575-4
- EC Name:
- Sodium N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxynaphthalene-2-carboxamidate
- Cas Number:
- 76918-62-2
- Molecular formula:
- C18H13N3O3.Na
- Details on test material:
- - Name of test material (as cited in study report): Naphtolon-Natrium TRF 8
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Animal specifics: Hoechst AG, conventional breed
- Source: Hoechst AG, breeding colony
- Age at study initiation: 3 months to 5 months
- Weight at study initiation: 2.9 kg
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet (e.g. ad libitum): standard laboratory diet (Altromin 2123) ad libitum, appr. 15 g hay daily
- Water (e.g. ad libitum): deionized chlorinated water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- 24 hours
rinsing with physiol. saline 24 h post instillation - Observation period (in vivo):
- 72 post instillation
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- Application of the substance to the conjunctival sac of the left eye of the animal, the right eye served as control.
REMOVAL OF TEST SUBSTANCE
- Washing: Washing with physiological saline at approx. 37 °C 24 h after administration and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution (24, 48 and 72 h after administration) took place
TOOL USED TO ASSESS SCORE: 0.01 % solution of fluorescein sodium, under UV light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: not reversible within observation period of 72h
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48 and 72 hours
- Max. score:
- 2
- Remarks on result:
- other: examination not possible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: not reversible within observation period of 72h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- other: not reversible within observation period of 72h
- Irritant / corrosive response data:
- The conjuntciva was diffuse red coloured and showed swelling with lids more than half closed at all times. It was discoloured grey and parts were ablated. The iris was not discernible through the opaque cornea (examination of iris score not possible). The cornea was rough and ablation of parts was observed. The animal showed continuing signs of severe irritation effects and therefore was humanely killed after 72 hours.
- Other effects:
- In the beginning light yellow, later on white mucous eye discharge was observed.
Any other information on results incl. tables
Evaluation Interval |
Cornea |
Conjunctiva |
Iris |
||
|
Opacity |
Redness |
Chemosis |
Discharge |
|
1 h |
4 |
2 |
4 |
X |
Examination of iris score not possible
|
24 h |
4 |
3 |
4 |
X |
|
48 h |
4 |
3 |
4 |
X |
|
72 h |
4 |
3 |
4 |
x |
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The test item induced severe damage to the eye. Based upon these findings, the test item is considered to cause "serious damage" to the rabbit eye.
- Executive summary:
- The primary eye irritation potential of
the test item was investigated according to OECD test guideline no. 405.
The test item was applied by instillation into the conjunctival sac of the
left eye of a single young adult New Zealand White rabbit, the right eye
served as control. The duration of treatment was 24 hours. The scoring of
eye reactions was performed 30 - 60 min, 24, 48 and 72 hours after
application. The mean scores were calculated across 3 scoring times (24,
48 and 72 hours after application) for iris, cornea, conjunctiva redness,
and conjunctiva chemosis, separately.
After application the conjuntciva was diffuse red coloured and showed swelling with lids more than half closed at all times. It was discoloured grey and parts were ablated. The iris was not discernible through the opaque cornea (examination of iris score not possible). The cornea was rough and ablation of parts was observed. In the beginning light yellow, later on white mucous eye discharge was observed. The animal showed continuing signs of severe irritation effects and therefore was humanely killed after 72 hours.
Thus, the test item induced severe damage to the eye. Based upon these findings, the test item is considered to cause "serious damage" to the rabbit eye.
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