Registration Dossier
Registration Dossier
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EC number: 205-080-2 | CAS number: 132-87-6
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- data from experimental reports following standard testing procedures
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- 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 the test chemical 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:
- 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.
Test system
- Type of coverage:
- open
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- 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:
- single exposure
- 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.
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0.5
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- no irritation was observed
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- The result obtained from present study reveals that the test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid was non irritant to skin of the New Zealand white rabbits when applied to the shaven back intact skin.
- 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. 3 female New Zealand White rabbits were used for the study.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 test compound was applied on a small area (approximately 6 cm2) of intact skin site.The rabbits were observed for signs of irritation till 14 days.
The result obtained from present study reveals that the test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid was non irritant to skin of the New Zealand white rabbits when applied to the shaven back intact skin.
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