Registration Dossier
Registration Dossier
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EC number: 265-633-9 | CAS number: 65212-76-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- occlusive conditions, 72 h reading missing, 8-day observation period, limited data to test substance, read across substance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occlusive conditions, 72 h reading missing
- GLP compliance:
- no
Test material
- Reference substance name:
- Calcium 4,5-dichloro-2-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphonatophenyl)-1H-pyrazol-4-yl]azo]benzenesulphonate
- EC Number:
- 265-634-4
- EC Name:
- Calcium 4,5-dichloro-2-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphonatophenyl)-1H-pyrazol-4-yl]azo]benzenesulphonate
- Cas Number:
- 65212-77-3
- Molecular formula:
- C16H12Cl2N4O7S2.Ca
- IUPAC Name:
- calcium 4,5-dichloro-2-{[3-methyl-5-oxo-1-(3-sulfonatophenyl)-4,5-dihydro-1H-pyrazol-4-yl]diazenyl}benzenesulfonate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- Type of cage: Cage made of stainless steel with wire mesh walk floors, floor area: 40 cm x 51 cm
No. of animals per cage: 1
Animal identification: Ear tattoo (= animal No.)
Room temperature: 20 - 26°C
Humidity: Conventional (about 30 - 70%)
Day/night rhythm: 12 h/12 h (6.00 - 18.00 hours/18.00 - 6.00 hours)
Bedding: No bedding in the cages; sawdust in the waste trays.
Diet: Ovator Solikanin 4 mm; Muskator-Werke Duesseldorf, FRG (about 130 g per animal per day)
Drinking water: About 250 ml per animal per day: demineralized water (Monday-Friday), tap water (weekends).
Mean weight of male animal: 2.64, of female animal 2.39 kg.
Acclimatization period: About 8 days before the beginning of the study in the skin laboratory; same housing conditions as during the study.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipping of the fur
- Vehicle:
- water
- Controls:
- other: untreated skin of the same animal
- Amount / concentration applied:
- 50% suspension (app. 0.5 g of the test substance is applied)
- Duration of treatment / exposure:
- 3 minutes and 4 hours
- Observation period:
- 8 days
- Number of animals:
- 2 (one male, one female)
- Details on study design:
- Clipping of the fur: At least 15 hours before the beginning of the study.
Application area: 2.5 cm x 2.5 cm
Appl. volume: The test patch (2.5 x 2.5 cm) is covered with an about 0.5 mm layer of the 50% suspension (thus about 0.5 g of the test substance is applied; because of the natural moisture of the skin, distilled water is used to prepare the suspensions so that the test can be carried out under as physiological conditions as possible).
Appl. site: Upper third of the back or flanks.
Removal of the test substance: At the end of the exposure period with Lutrol and Lutrol/water (1 :1).
Readings: 15 - 30 minutes after removal of the test patches and 24 h, 48 h, 8 d after the beginning of application.
Assessment according to J.H. Draize: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. In Dermal Toxicity pp. 46 - 59, 1959. Austin, Tex.: Association of Food and Drug Officials of the United States, Texas, State Department of Health.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: 3-min and 24-h application
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: 3-min and 24-h application
- Irritant / corrosive response data:
- No effects were observed 8 days after the treatment.
- Other effects:
- No other effects.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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