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EC number: 254-879-2 | CAS number: 40306-75-0
- 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
Endpoint summary
Administrative data
Description of key information
Both the end point studies indicate that the substance do not have any irritation effect on skin and eye.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Age:10 to 12 weeks
Sex:Female
Body weight range: 1.80kg±200g
Identification :By cage tag and corresponding colour body marking
No. of animals :Three
Acclimatization:The healthy rabbits selected for study was acclimatized to standard laboratory condition for one week in experimental room under Veterinary examination.
Randomization:After acclimatization and Veterinary examination three females were randomly selected. - Type of coverage:
- open
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- The 0.5 gm of test compound was applied on a small area (approximately 6 cm2) of intact skin site.
- Duration of treatment / exposure:
- exposure period of four hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- 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.
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 14 days
- Score:
- 0.5
- Max. score:
- 0.5
- Reversibility:
- fully reversible
- Remarks on result:
- other: No skin reaction was observed after four hours patch removal
- Other effects:
- The test compound 40306-75-0 when applied dermally on New Zealand White rabbit in the amount of 0.5 gm did not produce any clinical signs dermal irritation after 4 hours patch removal.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The dermal irritation index of New Zealand white rabbits is calculated as 0.00 and test compound can be classified under non irritant categories. Thus the result obtained from present study reveals that the test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid is non irritant to skin of the New Zealand white rabbits when applied to the shaven back intact skin.
- Executive summary:
The site of application was observed for skin reaction if any. The intact skin site of application of each animal was observed for signs of erythema and oedema and the responses were scored following Draize’s method at 60 min., 24, 48 and 72 hours after application. In addition to the observation of irritation, all local toxic effects, such as defatting of the skin, and any systemic adverse effects were fully described and recorded.
Draize Dermal Irritation Scoring System
Erythema and Eschar Formation
Value
Edema Formation
Value
No erythema
0
No edema
0
Very slight erythema (barely
perceptible)
1
Very slight edema (barely
perceptible)
1
Well-defined erythema
2
Slight edema (edges of area
well defined by definite raising)
2
Moderate to severe erythema
3
Moderate edema (raised
approximately 1 mm)
3
Severe erythema (beet redness)
to slight, eschar formation (injuries in depth)
4
Severe edema (raised more
than 1 mm and extending
beyond the area of exposure)
4
Thus, the test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid when applied at the dose level of 0.5 gm on shaven back skin of rabbit did not produced any irritation to skin during period of observation.
Reference
No serious reaction was observed at the site of application. The second patch was applied on the different shaven back side and removed after one hour. There were no signs of skin reaction observed at this site of application. Finally, a third patch was applied at a different site and was removed after four hour.No skin reactionwas observed after four hours patch removal.Finally, the animal was observed for 14 days, for any irritation and corrosion.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Age : 10 to 12 weeks
Sex : female
Body weight range : 1.80kg ±200g
Acclimatization : The rabbit was acclimatized to standard laboratory condition for 24 hours in experimental room before study.
No. of animals: Three - Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- A dose of 0.1gm of test substance was applied into the one eye of the rabbits. The other eye, which remains untreated, serves as a control.
- Duration of treatment / exposure:
- 21 days
- Observation period (in vivo):
- The eyes were examined at 1, 24, 48 and 72 hours after test substance application.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid in the amount of 0.1 gm moistened with distilled water and then placed in the conjunctival sac of one eye of each animal after gentle pulling the lower eye lid away from the eye ball. The eye lids were then gently held together for about one second to prevent the loss of the material. The other eyes which remains untreated, served as control.The eyes of the test animal did not washed for at least 24 hours following instillation of the test compound.
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 21 days
- Score:
- 0.1
- Max. score:
- 0.1
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- The test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid applied to the eye of New Zealand white rabbit at the dose level of 0.1 gm produced some blood vessels of conjunctiva were observed hyperemic at 1 hours after the application of test substance.
- Other effects:
- However, some blood vessels observed hyperemic upto 24 hours after the application of test compound. There were no other signs observed throughout the observation period of 21 days.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- From the result obtained from present study, it can be concluded that the test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid is non-irritant to the eyes of New Zealand white rabbit under test condition.
- Executive summary:
The test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid, when applied to conjunctival sac of rabbit in the amount of0.1 gmdid not produces any eye irritation or inflammation. Furthermore, no other clinical signs were recorded after application of test compound such as cage side activity, pain etc. In the confirmatory test, the test compound 3-acetamido-5-amino-4-hydroxy benzene sulphonic acid when applied to the conjunctival sac of the rabbits did not produce eye irritation during the entire observation period. However, some blood vessels observed hyperemic upto 24 hours after the application of test compound. There were no other signs observed throughout the observation period of 21 days.
Based on above findings, it can be concluded that the test compound is practically non-irritant at the tested dose level.
Reference
CORNEA
A.Opacity: degree of density (readings should be taken from most dense area)*
OBSERVATION |
SCORE |
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The dermal irritation index of New Zealand white rabbits is calculated as 0.00 and test compound can be classified under non irritant categories. Thus the result obtained from present study reveals that the test compound 3-acetamido-5-amino-4-hydroxy benzene sulphonic acid is non irritant to skin of the New Zealand white rabbits when applied to the shaven back intact skin. Based on the weight of evidence for the target substance 3-acetamido-5-amino-4-hydroxy benzene sulphonic acid, it is evident that the substance do not have irritation effect on skin.
Eye irritation :
The test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid, when applied to conjunctival sac of rabbit in the amount of0.1 gmdid not produces any eye irritation or inflammation. Furthermore, no other clinical signs were recorded after application of test compound such as cage side activity, pain etc. In the confirmatory test, the test compound 3-acetamido-5-amino-4-hydroxy benzene sulphonic acid when applied to the conjunctival sac of the rabbits did not produce eye irritation during the entire observation period. Based on above findings, it can be concluded that the test compound is practically non-irritant at the tested dose level.
Justification for selection of skin irritation / corrosion endpoint:
The end point has been selected since the study is a k1 data conducted by OECD method.
Justification for selection of eye irritation endpoint:
The end point has been selected since the study is a k1 data conducted by OECD method.
Justification for classification or non-classification
The substance will not be considered for classification in any of the irritation activity as the end point data indiactes that
3-acetamido-5-amino-4-hydroxy benzene sulphonic acid is non irritating in nature.
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