Registration Dossier
Registration Dossier
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EC number: 220-358-3 | CAS number: 2736-23-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Documentation insufficient for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FDA guidelines (Federal Register 38, no. 187, 27.09.1973, p 27019)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2,4-dichloro-5-sulphamoylbenzoic acid
- EC Number:
- 220-358-3
- EC Name:
- 2,4-dichloro-5-sulphamoylbenzoic acid
- Cas Number:
- 2736-23-4
- Molecular formula:
- C7H5Cl2NO4S
- IUPAC Name:
- 2,4-dichloro-5-sulphamoylbenzoic acid
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- The experimental animals were albino Himalayan rabbits (strain: Hoe: HIMK (SPFWiga); own breeding) used in weight from 1.846 to 2.392 kg. The animals were kept in individual cages and were given the standard feed ERKA 8300 (feed mill Robert Koch oHG, Hamm / Westphalia.). Food and water were available ad libitum.
Test system
- Vehicle:
- other: 0.05 ml of Polyethylen glycol 400
- Controls:
- other: The right eye served as an untreated control.
- Amount / concentration applied:
- 100 mg of powdered substance into 0.05 ml of Polyethylen glycol 400
- Duration of treatment / exposure:
- 24h
- Observation period (in vivo):
- 72h
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- The substance was applied in the conjunctival sac of the left eye skin once.
The assessment of the irritation was with a loupe at 1, 7, 24, 48 and 72 hours after application. 24 hours after treatment, the eyes were washed with physiological saline. The 48 - and 72-hour value was determined according to the additional instillation of a drop of fluorescein sodium.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Time point:
- other: 24 h
- Remarks on result:
- other: Stimulation index: 46
- Irritant / corrosive response data:
- After application of the pasted substance the highest stimulation index was calculated of 46 after 24 hours.
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- After application of the pasted substance the highest stimulation index was calculated of 46 after 24 hours. Therefore, the substance is described as moderately irritating to mucous membranes.
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