Registration Dossier
Registration Dossier
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EC number: 275-269-2 | CAS number: 71215-81-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987: November 9 to 13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (1981)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 5-amino-2-chloro-N-(2,4-dimethylphenyl)benzenesulphonamide
- EC Number:
- 275-269-2
- EC Name:
- 5-amino-2-chloro-N-(2,4-dimethylphenyl)benzenesulphonamide
- Cas Number:
- 71215-81-1
- Molecular formula:
- C14H15ClN2O2S
- IUPAC Name:
- 5-amino-2-chloro-N-(2,4-dimethylphenyl)benzene-1-sulfonamide
- Test material form:
- solid: particulate/powder
- Details on test material:
- Description: brown coloured lumpy powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Rosemead Rabbits, Waltham Abbey, Essex, U.K. and Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire, U.K
- Age at study initiation: 12-16 weeks old
- Weight at study initiation: 2.50-3.06 kg
- Housing: The animals were individually housed in suspended metal cages
- Diet (e.g. ad libitum): Free access to mains drinking water and food (rabbit Diet, Preston Farmers Limited' New Leake, Boston, Linco'lnshire, u.K.) was allowed throughout the study.
- Water (e.g. ad libitum): Free access to mains drinking water and food (rabbit Diet, Preston Farmers Limited' New Leake, Boston, Linco'lnshire, u.K.) was allowed throughout the study.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-19
- Humidity (%): 45-50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg (corresponding to colume of 0.09 mL when gently compacted into an adapted syringe
- Duration of treatment / exposure:
- The upper and lower eyelids were held together for about one second immediately after application, to prevent loss of the test material from the eye, and then released.
- Observation period (in vivo):
- 72h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
none
SCORING SYSTEM: Draize (1959)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1; 2 & 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant in absence of symptoms after 1; 24; 48 & 72h
- Irritation parameter:
- iris score
- Basis:
- animal: #1; 2 & 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 1h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 48/72h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #2 & 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24h (considering score of 2 after 1h for these 2 animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1; 2 & 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24h (for 2 animals considering score of 1 after 1h) and not relevant for animal (with score of 0 after 1h)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- ACDMA is non-irritant to rabbit eye in in vivo test performed according to OECD TG 405 & GLP following CLP criteria.
- Executive summary:
ACDMA is non-irritant to rabbit eye in in vivo test performed according to OECD TG 405 & GLP following CLP criteria.
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