Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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:
1980
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

Constituent 1
Chemical structure
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

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.