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Toxicological information

Skin irritation / corrosion

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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:
1981
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

Constituent 1
Chemical structure
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

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