Registration Dossier
Registration Dossier
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EC number: 213-758-4 | CAS number: 1008-72-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to internationally accepted testing guidelines, not GLP
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)
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium 2-formylbenzenesulphonate
- EC Number:
- 213-758-4
- EC Name:
- Sodium 2-formylbenzenesulphonate
- Cas Number:
- 1008-72-6
- Molecular formula:
- C7H5NaO4S
- IUPAC Name:
- Sodium 2-formylbenzenesulfonate
- Test material form:
- solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: HC: NZW, Fa. Hacking & Churchill ltd., Huntingdon, UK
- Weight at study initiation: average weight for each animal: about 3 kg
- Housing: in air-conditions room in individual cages
- Diet: ad libitum
- Water: ad libitum (drinking water)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21 °C
- Humidity (%): 40-50 %
- Photoperiod (hrs dark / hrs light): The light/dark cycle was 12 hours per day (artificial light from 7 till 19 h).
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 g of solid substance - Duration of treatment / exposure:
- The test sample was applied into the conjunctival sac of one eye of each rabbit.The upper and lower eyelids were held together for several seconds, to avoid any loss of test sample.
- Observation period (in vivo):
- 7 days. The effects were recorded after 1h, 24h, 48h and till 7 days after treatment.
- Number of animals or in vitro replicates:
- 3 males albino rabbits.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): 24 hours after testing the treated eye was washed with saline solution.
SCORING SYSTEM: DRAIZE,J.H.; The Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics, pp. 49 - 52. Association of Food and Drug Officials of the United States, Topeka,Kansas, 1965
TOOL USED TO ASSESS SCORE: Ophthalmoscopy. For the assessment of damages a drop of fluorescein solution was put in the eye, the eye was washed and then was examined by UV-light.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Eye rinsed after 24h from application
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Eye rinsed after 24h from application
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Eye rinsed after 24h from application
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: Eye rinsed after 24h from application
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: Eye rinsed after 24h from application
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: Eye rinsed after 24h from application
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: Eye rinsed after 24h from application
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: Eye rinsed after 24h from application
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: Eye rinsed after 24h from application
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Eye rinsed after 24h from application.
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Eye rinsed after 24h from application
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Eye rinsed after 24h from application
- Irritant / corrosive response data:
- The only adverse effects observed during the study were:
- redness (level 1) 24h after exposure only in animal 3 that was fully reversible after 72h
- some liquid excretion from the eye of each of three animals 1h after exposure but fully reversible after 24h for all animals.
The observation after 24h, 48h, 72h and 7 days showed no sign of cornea opacity, no effect on iris and no chemosis for none of the three rabbits.
Applicant's summary and conclusion
- Interpretation of results:
- other: not eye irritant according to the CLP Regulation (EC n.1272/2008)
- Conclusions:
- The substance is not eye irritating according to the CLP Regulation (EC n. 1272/2008).
- Executive summary:
The substance has been tested for eye irritation on three male albino rabbits.
The study was conducted according to the OECD Guideline N. 405. The eye treated was washed 24h after exposure with saline solution.
The only adverse effects observed during the study were:
- redness (level 1) 24h after exposure only in animal 3 that was fully reversible after 72h
- some liquid excretion from the eye of each of three animals 1h after exposure but fully reversible after 24h for all animals.
The observation after 24h, 48h, 72h and 7 days showed no sign of cornea opacity, no effect on iris and no chemosis for none of the three rabbits.
The substance is not eye irritating according to the CLP Regulation (EC n. 1272/2008).
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