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Registration Dossier
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EC number: 253-042-9 | CAS number: 36451-09-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988-04-12 to 1988-04-22
- 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:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 04-1984
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 05-1981
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, Germany
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.8 - 3.3 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
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: PEG 400
- Controls:
- no
- Amount / concentration applied:
- 500 mg moistened with 0.6 mL PEG 400
- Duration of treatment / exposure:
- 4 h
- Observation period:
- Up to 7 days
- Number of animals:
- 3
- Details on study design:
- On the day before the test each of a group of three rabbits was clipped free of fur from the dorsal/flank area. Only animals with a healthy intact epidermis by gross observation were selected for the study.
On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of 500 mg of the test material was introduced under a 2.5 * 2.5 cm gauze patch and placed in position. The patch was secured in position with a strip of surgical adhesive tape.
Four hours after application the patches were removed from each animal and any residual test material removed with tap water.
Approximately 30-60 min following the removal of the patches, and 24, 48 and 72 hours and 7 days later, the test sites were examined for evidence of primary irritation.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hrs
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The observed effects were 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 404 was to assess the irritancy potential of the test item to the skin of the New Zealand White rabbits.
Results
The application of the test material to the intact skin produced no significant irritation.
Conclusion
The test material gave no indication for skin irritation in rabbits.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material gave no indication for skin irritation in rabbits.
- Executive summary:
This study was performed according to GLP and is fully compliant with OECD GL 404. Based on the results of this study it was concluded that the test item is not irritant to the skin of rabbits.
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