Registration Dossier
Registration Dossier
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EC number: 253-042-9 | CAS number: 36451-09-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988-04-19 to 1988-04-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 02-1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 04-1984
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-diazo-3,4-dihydro-4-oxonaphthalene-1-sulfonyl chloride
- EC Number:
- 253-042-9
- EC Name:
- 3-diazo-3,4-dihydro-4-oxonaphthalene-1-sulfonyl chloride
- Cas Number:
- 36451-09-9
- Molecular formula:
- C10H5ClN2O3S
- IUPAC Name:
- 3-(-lambda5-diazynylidene)-4-oxo-3,4-dihydronaphthalene-1-sulfonyl chloride
- 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: Hoechst AG, Kastengrund, Germany
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.4 - 3 kg
- Housing: single
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- up to 72 hrs
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
-Washing: no
SCORING SYSTEM: according to OECD Guideline
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.9
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
Any other information on results incl. tables
Study design
The purpose of this GLP study performed according to OECD GL 405 was to assess the eye irritancy potential of the test item in New Zealand White rabbits.
Results
The application of the test material caused an eye irritation. The observed effects were reversible within 7 days after application.
Conclusion
Based on the obtained results the test item can be classified as eye irritant.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- The application of the test material caused an eye irritation. The observed effects were reversible within 7 days after application.
- Executive summary:
This study was performed according to GLP and is fully compliant with OECD GL 405. The application of the test material caused an eye irritation in rabbits and the observed effects were reversible within 7 days after application. Therefore, the test item can be classified as eye irritant.
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