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EC number: 246-058-2 | CAS number: 24170-60-3
- 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:
- 9 January 1984 to 23 January 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- N-[2-[(2-cyano-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]acetamide
- EC Number:
- 246-058-2
- EC Name:
- N-[2-[(2-cyano-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]acetamide
- Cas Number:
- 24170-60-3
- Molecular formula:
- C19H19N7O5
- IUPAC Name:
- N-{2-[(2-cyano-4,6-dinitrophenyl)diazenyl]-5-(diethylamino)phenyl}acetamide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- None
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: EN 43'693.12
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Stability under storage conditions: until October 1988
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2110-2240 g
- Housing: Animals were housed individually in metal cages.
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland) ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Air changes (per hr): approximately 15 air changes/h
- Photoperiod (hrs dark / hrs light): 12 hours light/day
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye of each animal remained untreated and served as the control.
- Amount / concentration applied:
- 0.1 g of the test article was applied.
- Duration of treatment / exposure:
- One single application.
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- 0.1 g of the test article was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test material.
The left eye remained untreated and served as the control.
Scoring and assessment of local reactions:
The ocular reactions were examined 1, 24, 48, and 72 hours after substance instillation and again during the following observation period.
The ocular irritation scores were evaluated according to the scoring system.
The irritating and/or corrosive potential of the test article (theoretical range: non irritant - extremely irritant) was assessed on the basis of the maximum irritant effect observed
- in one or several of the ocular tissues (conjunctiva, iris, cornea), observed over the range of observation time
- in one or more animals and taking into account the reversibility of the effect.
SCORING SYSTEM: Evaluation score for ocular lesions.
CORNEA:
Opacity: degree of density (area most dense taken for reading).
- No ulceration or opacity: 0
- Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible: 1*
- Easily discernible translucent area, details of iris slightly obscured: 2*
- Nacrous area, no details of iris visible, size of pupil barely discernible: 3*
- Opaque cornea, iris not discernible through the opacity: 4*
IRIS:
- Normal: 0
- Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of these or combination of any there of, iris still reacting to light (sluggish reaction is positive): 1*
- No reaction to light , haemorrhage, gross destruction (any or a l l of these): 2*
CONJUNCTIVAE:
Redness: (refers to palpebral and bulbar conjunctivae, cornea and iris)
- Blood vessels normal: 0
- Some blood vessels definitely hyperaemic (injected): 1
- Diffuse, crimson colour, individual vessels not easily discernible: 2*
- Diffuse beefy red: 3*
CHEMOSIS:
Lids and/or nictating membranes
- No swelling: 0
- Any swelling above normal (includes nictating membranes): 1
- Obvious swelling with partial eversion of lids 2*
- Swelling with lids about half closed: 3*
- Swelling with lids more than, half closed: 4*
*Starred figures indicate positive effect.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The animals were free of findings at the 48 hours scoring. The animals showed a normal body weight development.
Any other information on results incl. tables
CORNEA |
|||
Animal No./Sex |
19/M |
20/M |
21/M |
After 1 h |
1 |
0 |
1 |
After 24 h |
0 |
0 |
0 |
After 48 h |
0 |
0 |
0 |
After 72 h |
0 |
0 |
0 |
IRIS |
|||
After 1 h |
0 |
0 |
0 |
After 24 h |
0 |
0 |
0 |
After 48 h |
0 |
0 |
0 |
After 72 h |
0 |
0 |
0 |
CONJUNCTIVA redness in bulbar and palpebral membranes |
|||
After 1 h |
2 |
2 |
2 |
After 24 h |
1 |
0 |
1 |
After 48 h |
0 |
0 |
0 |
After 72 h |
0 |
0 |
0 |
CONJUNCTIVA chemosis in lids and nictating membranes |
|||
After 1 h |
2 |
2 |
2 |
After 24 h |
0 |
0 |
0 |
After 48 h |
0 |
0 |
0 |
After 72 h |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 36'156/A is considered as non-irritant when applied to the rabbit eye.
- Executive summary:
The experiment was performed to determine the potential of FAT 36156/A to induce irritation/corrosion in New Zealand White rabbits according to the OECD Guideline 405. Three male rabbits were used in this study. 0.1 g of the test item was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were held together for about on second in order to prevent the loss of the test material. The left eye remained untreated and served as the control. The ocular reaction was examined 1, 24, 48 and 72 hours after substance instillation.
The test was finished after 3 observations days. The animals showed a normal body weight gain.Two animals showed conjunctival redness of score 1 at 24 h observation period which was reversed at 48 h observation period. No other reactions to treatment were recorded during the whole observation period.
Based on the results, FAT 36'156/A is considered as non-irritant when applied to the rabbit eye.
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