Registration Dossier
Registration Dossier
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EC number: 247-501-2 | CAS number: 26175-68-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed GLP and OECD guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-amino-2,5-dichloro-N,N-dimethylbenzenesulphonamide
- EC Number:
- 247-501-2
- EC Name:
- 4-amino-2,5-dichloro-N,N-dimethylbenzenesulphonamide
- Cas Number:
- 26175-68-8
- Molecular formula:
- C8H10Cl2N2O2S
- IUPAC Name:
- 4-amino-2,5-dichloro-N,N-dimethylbenzene-1-sulfonamide
- Details on test material:
- - Name of test material (as cited in study report): 1-Amino-2,5-dichlrbenzol-4-sulfonsaeure-dimethylamid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, 4414 Fuellinsdorf, Switzerland
- Age at study initiation: approx. 12 weeks
- Weight at study initiation: 2.3 - 3.0 kg
- Housing: individually in stainless steel cages with automatic drinking water supply and cleanig system
- Diet: pelleted standard Kliba 341, rabbit maintenance diet ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-2
- Humidity (%): 55+- 10
- Photoperiod : Light cycle 12 hours / day
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: THE RIGHT EYE SERVED AS UNTREATED CDNTROL.
- Amount / concentration applied:
- 0.1 g / undiluted
- Duration of treatment / exposure:
- single application, no rinsing
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 (2 males, 1 female)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: # 125, 126, 127 each
- Time point:
- other: mean of 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of irritation (cornea) at any time
- Irritation parameter:
- iris score
- Basis:
- animal: # 125, 126, 127 each
- Time point:
- other: mean of 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no signs of irritation (iris) at any time
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 125, 127 each
- Time point:
- other: mean of 24, 48, and 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 126
- Time point:
- other: mean of 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: initial signs of irritation (redness) were fully reversible within 24 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: # 125, 126, 127 each
- Time point:
- other: mean of 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: initial signs of irritation (chemosis) were fully reversible within 24 h
- Irritant / corrosive response data:
- discharge in two animals 1 h post application
- Other effects:
- NO ACUTE TOXICOLOGICAL SIGNS WERE OBSERVED IN THE ANIMALS DURING THE TEST PERIOD.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- not irritation and not corrosive
- Executive summary:
When testing for acute eye irritation/corrosion in rabbits according to OECD 405 the test substance showed no relevant signs of irritation (all mean scores 0 or 0.3). No destructions or irreversible alterations of the treated eye were observed. Thus it was concluded that the test substance is not irritating and not corrosive to eyes.
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