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EC number: 277-918-5 | CAS number: 74543-22-9
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- data is from experimental reports following standard operating procedures
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- To assess the ocular irritation parameter of 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid in accordance with OECD 405
- GLP compliance:
- no
Test material
- Reference substance name:
- 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid
- EC Number:
- 254-879-2
- EC Name:
- 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid
- Cas Number:
- 40306-75-0
- Molecular formula:
- C8H10N2O5S
- IUPAC Name:
- 3-acetamido-5-amino-4-hydroxybenzenesulfonic acid
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material : 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid
- Molecular formula : C8H10N2O5S
- Molecular weight : 246.24 g/mole
- InChI: 1S/C8H10N2O5S/c1-4(11)10-7-3-5(16(13,14)15)2-6(9)8(7)12/h2-3,12H,9H2,1H3,(H,10,11)(H,13,14,15)
- Substance Type: Organic
- Physical State: Solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material : 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid
- Molecular formula : C8H10N2O5S
- Molecular weight : 246.24 g/mole
- InChI: 1S/C8H10N2O5S/c1-4(11)10-7-3-5(16(13,14)15)2-6(9)8(7)12/h2-3,12H,9H2,1H3,(H,10,11)(H,13,14,15)
- Substance Type: Organic
- Physical State: Solid
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Sex: female
- Age at study initiation: 10-12 weeks
- Weight at study initiation: 2.00 kg±200 gms
- Housing:animals were housed individually in stainless steel cages provided with steel mesh bottom and facilities for food and water
- Diet (e.g. ad libitum): Pelleted feed supplied by Pranav Agro
- Water (e.g. ad libitum): Community tap water kept in glass bottles, ad libitum
- Acclimation period: The healthy rabbits selected for study were acclimatized to laboratory conditions 24 hours prior to testing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 -25 deg C
- Humidity (%): 40-60%
- Air changes (per hr): air conditioned rooms with 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours dark cycle
Test system
- Vehicle:
- water
- Controls:
- yes
- Amount / concentration applied:
- 0.1 gm of test chemical moistened with water
- Duration of treatment / exposure:
- the eyelids were gently pulled together for about one second to prevent loss of material
- Observation period (in vivo):
- The eyes were examined at 1, 24, 48 and 72 hours after test substance application.
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 3 female rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed
SCORING SYSTEM:Scale of weighted scores for grading the severity of ocular lesions developed by Draize et al
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: hand-slit lamp
Examination of reactions was facilitated by use of biomicroscope and hand slit lamp. After recording the observations at 24 hours, the eyes were further examined with the aid of fluorescein.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1.25
- Max. score:
- 110
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The test compound didnot produce any irritation through out the observation period. However, some blood vessels observed hyperemic upto 24 hours after application of test compound. There were no other signs of irritation observed throughout the observation period of 21 days.
- Other effects:
- 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid did not produce any clinical signs of toxicity throughout the examination period of 21 days.
Any other information on results incl. tables
TABLE- 1 GRADING OF OCULAR LESIONS
S.NO/ SEX |
|
OBSERVATION |
Score |
Total |
Total Score |
|||
1/F
|
1 hr |
24hrs |
48 hrs |
72 hrs |
||||
Cornea |
A. Opacity-Degree of Density |
0 |
0 |
0 |
0 |
0 |
0×0×5=0 |
|
B. Area of Cornea Involved |
0 |
0 |
0 |
0 |
0 |
|||
Iris |
A. Values |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
A. Redness |
1 |
0 |
0 |
0 |
1 |
1+0+0×5=5 |
|
B. Chemosis |
0 |
0 |
0 |
0 |
0 |
|||
C. Discharge |
0 |
0 |
0 |
0 |
0 |
|||
2/F |
Cornea |
A. Opacity-Degree of Density |
0 |
0 |
0 |
0 |
0 |
0×0×5=0 |
B. Area of Cornea Involved |
0 |
0 |
0 |
0 |
0 |
|||
Iris |
A. Values |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
A. Redness |
1 |
0 |
0 |
0 |
1 |
1+0+0×5=5 |
|
B. Chemosis |
0 |
0 |
0 |
0 |
0 |
|||
C. Discharge |
0 |
0 |
0 |
0 |
0 |
|||
3/F |
Cornea |
A. Opacity-Degree of Density |
0 |
0 |
0 |
0 |
0 |
0×0×5=0 |
B. Area of Cornea Involved |
0 |
0 |
0 |
0 |
0 |
|||
Iris |
A. Values |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
A. Redness |
1 |
0 |
0 |
0 |
1 |
1+0+0×5=5 |
|
B. Chemosis |
0 |
0 |
0 |
0 |
0 |
|||
C. Discharge |
0 |
0 |
0 |
0 |
0 |
|||
Grand total |
15.00 |
|||||||
Mean |
5.0 |
|||||||
Eye Irritation Scoring index |
1.25 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- The overall irritation index of 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid was 1.25 after 72 hours.
Also 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid did not produce any clinical signs of toxicity throughout the examination period of 21 days.
Hence, under the test conditions, 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid can be concluded to be not irritating to New Zealand White rabbit eyes. - Executive summary:
An ocular irritation study was conducted on New Zealand white rabbits in accordance with OECD 405 to assess the irritation parameter of 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid. 3 female New Zealand White rabbits were used for the study. 0.1 gm of the test chemical was moistened with water was instilled in the conjunctival sac of rabbits after gently pulling the lower lid away from the eyeball. The other eye which remained untreated served as a control. The ocular lesions were evaluated at 1, 24, 48 and 72 hours after the treatment. The grades of ocular reactions (conjunctiva, cornea and iris) were recorded at each observation. To determine the reversibility of the effect the animals were observed normally for 21 days. Any other lesions in the eye viz pannus, staining were observed and scored accordingly. Examination of reactions was facilitated by use of biomicroscope and hand slit lamp. Individual animal weights before and during the study was observed.
The overall irritation index of 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid was 1.25 after 72 hours.
Also 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid did not produce any clinical signs of toxicity throughout the examination period of 21 days.
Hence, under the test conditions, 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid can be concluded to be not irritating to New Zealand White rabbit eyes.
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