Registration Dossier
Registration Dossier
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EC number: 204-482-5 | CAS number: 121-57-3
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:
- other: GLP-study according to OECD guideline 405
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
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:
- Sulphanilic acid
- EC Number:
- 204-482-5
- EC Name:
- Sulphanilic acid
- Cas Number:
- 121-57-3
- Molecular formula:
- C6H7NO3S
- IUPAC Name:
- 4-aminobenzene-1-sulfonic acid
- Details on test material:
- - Name of test material (as cited in study report): sulfanilic acid
- Physical state: light grey solid
- Analytical purity: > 98.5%
- Lot/batch No.: oohl-NFC 001
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Housing:
The animals were singly housed in suspended stainless steel caging with mesh floors which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals (Natl. Res. Council, 1996). Litter paper was placed
beneath the cage and was changed at least three times per week.
Animal Room Temperature and Relative Humidity Ranges: 18-22ºC and 33-69%, respectively.
Photoperiod: 12-hour light/dark cycle
Acclimation Period: 5 or 12 days
Food: Pelleted Purina Rabbit Chow #5326
Water: Filtered tap water was supplied ad libitum by an automatic water dispensing system.
Contaminants: There were no known contaminants reasonably expected to be found in the food or water at levels which would have interfered with the results of this study. Analyses of the food and water are conducted regularly and the records are kept on file at Eurofins PSL.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 1 ml
- Duration of treatment / exposure:
- 21 d
- Observation period (in vivo):
- 21 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- First one rabbit was tested and subsequently two further rabbits were used.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- result
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Other effects:
- All animals appeared active and healthy during the study. Apart from the eye irritation noted,
there were no other signs of gross toxicity, adverse pharmacologic effects, or abnormal behavior.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- In a GLP-study according to OECD test guideline 405, the registered substance is severly eye irritating, but all effects reverse latest after 21 days.
- Executive summary:
In a GLP-study according to OECD test guideline 405, the registered substance is severly eye irritating, but all effects reverse latest after 21 days.
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