Registration Dossier
Registration Dossier
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EC number: 222-823-6 | CAS number: 3622-84-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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 eye 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 405 (Acute Eye 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues 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: 2.136-2.591 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): 20.3-21.7°C
- Humidity (%): 53-66%
- Photoperiod (hrs dark / hrs light): 12h light and 12h dark
Test system
- Vehicle:
- not specified
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution): a volume of 0.1 ml test substance was instilled as such into the conjunctival sac of the rabbits - Duration of treatment / exposure:
- the eyes of the test animals were washed after 24h
- Observation period (in vivo):
- 72h
- Number of animals or in vitro replicates:
- 3 females (nulliparous and non-pregnant
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, 24h after instillation
SCORING SYSTEM: Draize 1959 scoring
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- animal: all 3
- Time point:
- other: 1h, 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: score = 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: score = 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0
- Irritant / corrosive response data:
- The mean score of ocular lesion is 0 +/- 0.0 at 1, 24, 48 and 72h. Non of the animals showed any lesions throughout the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The maximum mean score for ocular lesions observed in the experiment was 0. Hence, under the experimental conditions the test substance, N-n-butylbenzenesulphonamide (Proviplast 024) was considered as Non-Irritant (N) to the eyes of New Zealand white rabbits.
- Executive summary:
An acute eye irritation/corrosion study was conducted with N-n-butylbenzenesulphonamide in New Zealand white rabbits. The maximum mean score for ocular lesions observed in the experiment was 0. Hence, under the experimental conditions the test substance, N-n-butylbenzenesulphonamide was considered as Non-Irritant to the eyes of New Zealand white rabbits.
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