Registration Dossier
Registration Dossier
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EC number: 222-823-6 | CAS number: 3622-84-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Justification for not submitting the in vitro study.
The new legal requirements (21 June 2016) require an in vitro skin irritation study. However the previous data requirements were met with an in vivo study during dossier compilation for the >1000 T/y tonnage band. Therefore there is no need to repeat the study using the alternative test method.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N-butylbenzenesulphonamide
- EC Number:
- 222-823-6
- EC Name:
- N-butylbenzenesulphonamide
- Cas Number:
- 3622-84-2
- Molecular formula:
- C10H15NO2S
- IUPAC Name:
- N-butylbenzenesulfonamide
- Details on test material:
- - Name of test material (as cited in study report):N-n-butylbenzenesulphonamide (Proviplast 024) BBSA
- Physical state: clear liquid
- Analytical purity: 99.94%
- Lot/batch No.: 200911030035
- Storage condition of test material: stored at dry cool and well ventilated area in the utility room
- Other:
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: From the animal house facility of IIBAT, Padappai-601 301, Kancheepuram district, Tamil Nadu, India
- Weight at study initiation: 2.246-2.381 kg
- Housing: animals were housed individually in standard rabbit cages
- Diet (e.g. ad libitum): ad libitum standard pellet feed supplied by M/s Amrut Laboratory Animal Feed, Pune -30
- Water (e.g. ad libitum): ad libitum UV treated water
- Acclimation period:5 days prior to the experiment in the test room
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.4-21.9°C
- Humidity (%): 51-60%
- Photoperiod (hrs dark / hrs light): 12h light and 12h dark
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: closely clipping
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated site was kept as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL was evenly applied as such to the clipped area of rabbits - Duration of treatment / exposure:
- 4h
- Observation period:
- all animals were observed at 60 min, 24, 48, and 72h after removal of gauze patches
- Number of animals:
- 3 females (nulliparous and non pregnant)
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): test substance was removed with water
- Time after start of exposure: 4h
SCORING SYSTEM: Draize 1959 scoring
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 60 min, 24, 48, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0
- Irritant / corrosive response data:
- No dermal reaction was seen at treated and untreated area of all animals at all time points 60 min, 24, 48, 72h.
- Other effects:
- None of the animals showed clinical signs of toxicity.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- It is concluded that Acute Dermal irritation/corrosion of test substance N-n-butylbenzenesulphonamide (Proviplast 024) was classified as Non-Irritant to skin of New Zealand White rabbits under the experimental conditions tested.
- Executive summary:
An acute dermal irritation/corrosion was conducted with N-n-butylbenzenesulphonamide in New Zealand White Rabbits.No dermal reaction was seen at treated and untreated area of all animals at all time points 60 min, 24, 48, 72h. It is concluded that Acute Dermal irritation/corrosion of test substance was classified as Non-Irritant to skin of New Zealand White rabbits under the experimental conditions tested.
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