Registration Dossier
Registration Dossier
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EC number: 943-210-6 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- In vivo study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 1973
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO)
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- tetrasodium 15-[(Z)-2-{4-[(E)-2-{4-[(E)-2-{2,5-dimethyl-4-[(E)-2-(4-sulfophenyl)diazen-1-yl]phenyl}diazen-1-yl]-2-sulfophenyl}ethenyl]-3-sulfophenyl}diazen-1-yl]-10,12-dioxa-2,3-diaza-11-cupratricyclo[11.4.0.0^{4,9}]heptadeca-1(17),2,4,6,8,13,15-heptaene-6-sulfonate
- EC Number:
- 943-210-6
- Molecular formula:
- Not applicable. UVCB Substance
- IUPAC Name:
- tetrasodium 15-[(Z)-2-{4-[(E)-2-{4-[(E)-2-{2,5-dimethyl-4-[(E)-2-(4-sulfophenyl)diazen-1-yl]phenyl}diazen-1-yl]-2-sulfophenyl}ethenyl]-3-sulfophenyl}diazen-1-yl]-10,12-dioxa-2,3-diaza-11-cupratricyclo[11.4.0.0^{4,9}]heptadeca-1(17),2,4,6,8,13,15-heptaene-6-sulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Russian breed- Weight at study initiation: 1.8 to 2.9 kg- Housing: single housed in metal cage (overall dimensions 47x32x34 cm)- Diet: standard diet of Nafag ad libitum- Water: drinking water ad libitum- Acclimation period: 8 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 18 ± 1°C- Humidity (%): 55 ± 5 %- Photoperiod (hrs dark / hrs light): 14 hours light/day
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL- Amount applied (volume or weight with unit): 0.5 g
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 10 days
- Number of animals:
- 3 males and 3 females rabbit
- Details on study design:
- TEST SITE- Area of exposure: 2.5 X 2.5 cm- Type of wrap if used: A gauze patch of 2.5 x 2.5 cm laden with test substance was applied immediately to the prepared skin. The patch was covered with an impermeable foil of 5 x 5 cm, which was fixed to the body of the animals with adhesive tape.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 38
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: shaved skin
- Irritation parameter:
- erythema score
- Basis:
- animal: 40
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: shaved skin
- Irritation parameter:
- erythema score
- Basis:
- animal: 42
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: shaved skin
- Irritation parameter:
- erythema score
- Basis:
- animal: 29
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: No skin reaction observed
- Remarks on result:
- other: shaved skin
- Irritation parameter:
- erythema score
- Basis:
- animal: 31
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: No skin reaction observed
- Remarks on result:
- other: shaved skin
- Irritation parameter:
- erythema score
- Basis:
- animal: 33
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: No skin reaction observed
- Remarks on result:
- other: shaved skin
- Irritation parameter:
- edema score
- Basis:
- animal: 38
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: No skin reaction observed
- Remarks on result:
- other: shaved skin
- Irritation parameter:
- edema score
- Basis:
- animal: 40
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: shaved skin
- Irritation parameter:
- edema score
- Basis:
- animal: 42
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: shaved skin
- Irritation parameter:
- edema score
- Basis:
- animal: 29
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: No skin reaction observed
- Remarks on result:
- other: shaved skin
- Irritation parameter:
- edema score
- Basis:
- animal: 31
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: No skin reaction observed
- Remarks on result:
- other: shaved skin
- Irritation parameter:
- edema score
- Basis:
- animal: 33
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: No skin reaction observed
- Remarks on result:
- other: shaved skin
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- not classified according to CLP Regulation (EC n. 1272/2008)
- Conclusions:
- Under the conditions of this experiment preparation the test item was found non irritating when applied to intact or abraded rabbit skin.
- Executive summary:
The substance has been tested for skin irritation according to patch test technique as described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). The substance was applied to shaved and abraded skin of 6 rabbits. Before application the test material was wetted with tap water. The gauze patches were removed 24 hours after application. The reaction of the skin was appraised upon removal during an observation period of 10 days. Under the conditions of this experiment preparation the test item was found non irritating when applied to intact or abraded rabbit skin.
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