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EC number: 410-070-8 | CAS number: 141880-36-6 ACID RED HT 3728; ERIONYL RED HT 3728
- 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:
- 11 August 1992 to 20 November 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- code number: FAT 45155/B
batch No.: HT 3728/ TV 1
physical appearance: powder, dark red
purity: 60-70 %
Storage conditions: room temperature, keep dark
Validity: May 15, 1997
storage: room temperature, keep dark
expiration date: May. 15, 1997
safety precautions: gloves and face masks
Constituent 1
- Specific details on test material used for the study:
- Test article: FAT 45155/B
Trade name: ERIONYL ROT HT 3728
Batch No.: HT 3728/TV 1
Purity: 60 - 70 %
Physical properties: powder; dark red
Storage conditions: room temperature; keep dark
Validity: May 15, 1997
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- The rabbits were recognized by the international guideline as the recommended test system. Total number of animals are one female and two males.
TEST ANIMALS
- breeder: Dr. K. Thomae GMBH Chemisch-pharmazeutische Fabrik D-7950 Biberach/Riss
- acclimatisation period: at lease 5 days
- Weight at study initiation: 2500-2730 g
- Housing: individually in metal cages
- Feed: ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: fresh water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): a 12 hrs light cycle day
Test system
- Vehicle:
- water
- Controls:
- other: The right eye remained untreated and was used as the control.
- Amount / concentration applied:
- The application volume was 0.1 ml (91 mg) per animal.
- Duration of treatment / exposure:
- 0.1 ml (91 mg) of FAT 45155/B was placed into the conjunctival sac of the left 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 article.
- Observation period (in vivo):
- viability/mortality: Daily;
ocular reaction: ocular reactions were evaluated 1, 24, 48 and 72 hours after the instillation of test substance
body weight: at start and on days 3 and 7 - Number of animals or in vitro replicates:
- one female and two males
- Details on study design:
- The ocular reactions were evaluation 1, 24, 48 and 72 hours after the instillation of test substance according to the OECD scoring system. A slit-lamp was used to facilitate the evaluation. The irritation/corrosive potency of test substance was classified.
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
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24/48/72 h
- Score:
- 1.11
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- No irritation or corrosion was observed.
- Other effects:
- The eye reactions observed were reversible until the end of the observation period on day 7.
Any other information on results incl. tables
Individual eye score:
Animal No. |
Time point |
Corneal opacity |
Iris |
Conjunctiva |
|
|
Redness |
Chemosis |
|||
1 |
After 24 h |
0 |
0 |
1 |
0 |
2 |
0 |
0 |
1 |
1 |
|
3 |
0 |
0 |
2 |
1 |
|
1 |
After 48 h |
0 |
0 |
1 |
0 |
2 |
0 |
0 |
1 |
0 |
|
3 |
0 |
0 |
1 |
0 |
|
1 |
After 72 h |
0 |
0 |
1 |
0 |
2 |
0 |
0 |
1 |
0 |
|
3 |
0 |
0 |
1 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 45155/B is considered as non-irritant to rabbit eye.
- Executive summary:
A GLP-compliant study was performed to access the primary eye irritation potential of FAT 45155/B. Two males and one female were exposed a single dose of test substance (0.1 ml or 91 mg per animal) placed in the eyes of rabbits. The reaction was assessed at 1, 24, 48 and 72 h intervals after administration. Under the experimental conditions employed the test substance induced reactions of the iris and conjunctiva when instilled into the conjunction sac of albino rabbits' eyes. The mean values of the readings 24 to 72 h after instillation for Cornea and Iris was ‘0’ while for redness and chemosis was 1.11 and 0.22, respectively, which are below the threshold of significance. The eye reactions observed were reversible until the end of the observation period on day 7. Based on the study result of this test, FAT 45155/B is considered as non-irritant to rabbit eye.
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