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EC number: 201-989-3 | CAS number: 90-40-4
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- To assess the dermal irritation parameter of 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid in accordance with OECD 404
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sex: female
- Source: IIRT
- Age at study initiation: 10-12 weeks
- Weight at study initiation: 1.90kg
- 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 one week 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
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 gm
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24,48 and 72 hours till 14 days after application
- Number of animals:
- 3 female rabbits
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage:approx 6 square cm
- Type of wrap if used: impervious dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: after patch removal, the site of application was cleaned with luke warm water
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : 1, 24,48 and 72 hours
SCORING SYSTEM: The intact skin site of application was observed for erythema and edema and scored according to Draize method.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The test compound didnot produce any signs of irritation through out the observation period
- Other effects:
- The test compound did not produce any clinical signs of toxicity through out the study.
Any other information on results incl. tables
Individual Animal Dermal irritation scores
Rabbit number |
Sex |
Intact skin |
|||||||||||
3 minutes |
4 hours |
24 hours |
48 hours |
72 hours |
14 days |
||||||||
Erythema
|
Edema
|
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythemea |
Edema |
Erythema |
Edema |
||
01 |
Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
02 |
Female |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
03 |
Female |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Total |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mean |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Grand total |
0.0 |
Clinical signs
Sex |
Rabbit number |
Duration |
|||||
3 minutes |
4 hours |
24 hours |
48 hours |
72 hourss |
14 days |
||
Female |
01 |
N |
N |
N |
N |
N |
N |
02 |
N |
N |
N |
N |
N |
N |
|
03 |
N |
N |
N |
N |
N |
N |
Where N-no clinical signs observed; C- Clinical signs observed
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid did not produce erythema or edema throughout the observation period of 14 days.The dermal irritation index was calculated to be 0.00.3-acetamido-5-amino-4-hydroxybenzenesulphonic acid did not produce any clinical signs of toxicity through out the study.
Based on the score and observations, 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid can be considered not irritating to skin and can be classified under the category 'Not Classified'. - Executive summary:
A dermal irritation study was conducted on New Zealand white rabbits in accordance with OECD 404 to assess the irritation parameter of 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid. The animals were prepared 24 hrs prior to application of test product. The furs from the dorsal area of trunk of animals were removed with electric clippers exposing an area measuring approximately 6 cm2 of body surface area of animal. The care was taken such that abrasion penetrated the Stratum corneum only and not dermis. 0.5 gm of the test compound was applied on a small area 6 square cms of the intact test site. Each site of application was covered with an impervious dressing which was secured with an adhesive tape. The animals were housed individually and restrained by the use of plastic collars. After patch removal [4 hours later] the unabsorbed test chemical was removed and the test site was washed with lukewarm water. The intact skin site of application was observed for erythema and edema at 1, 24,48 and 72 hours till 14 days after application and scored according to Draize method.
3-acetamido-5-amino-4-hydroxybenzenesulphonic acid did not produce erythema or edema throughout the observation period of 14 days. The dermal irritation index was calculated to be 0.00. 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid did not produce any clinical signs of toxicity throughout the study.
Based on the score and observations, 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid can be considered not irritating to skin and can be classified under the category 'Not Classified'
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