Registration Dossier
Registration Dossier
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EC number: 263-856-6 | CAS number: 63105-49-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979-10-29 to 1979-11-01
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FDA guideline
- GLP compliance:
- no
Test material
- Reference substance name:
- Trisodium [5-acetamido-4-hydroxy-3-[[2-hydroxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonato(5-)]cuprate(3-)
- EC Number:
- 263-856-6
- EC Name:
- Trisodium [5-acetamido-4-hydroxy-3-[[2-hydroxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonato(5-)]cuprate(3-)
- Cas Number:
- 63105-49-7
- Molecular formula:
- C20H14CuN3O15S4.3Na C20H14CuN3Na3O15S4
- IUPAC Name:
- trisodium [5-acetamido-4-hydroxy-3-[[2-hydroxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonato(5-)]cuprate(3-)
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Remarks:
- Albino Himalayan (strain: Hoe:HIMK SPFWiga)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: inhouse
- Weight at study initiation: 1.5 - 2.0kg
- Housing: individual
- Diet (e.g. ad libitum): standard food ERKA 8300 (Futtermittelwerk Robert Koch oHG, Hamm, Westfalen), ad libitum
- Water (e.g. ad libitum): ad libitum
IN-LIFE DATES: From: 29. Oct To: 1. Nov 1979
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- physiological saline
- Remarks:
- 0.9%
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg of test substance powder pasted with 0.2 mL of physiological saline on each patch (2.5 x 2.5 cm²) each for shaved and abraded skin per animal - Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2 x (2.5 x 2.5 cm²) per rabbit
OBSERVATION TIME POINTS
24h 48h 72h after application
SCORING SYSTEM:
- Method of calculation: according to §1500.41 Federal register 38, No. 187, 27.9.1973 p. 27019 (equivalent to Draize scoring)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.61
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h on 5 of 6 animals
- Remarks:
- slicht erythema (score 1) would have reversed within 21 days, therefore no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- shaved skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- shaved nd abraded
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- other: 24 h and 72 h
- Score:
- 1
- Max. score:
- 8
- Reversibility:
- fully reversible within: 72 h on 5 of 6 animals
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- Re-evaluation of test result in 1992: not irritating to skin
Any other information on results incl. tables
| animal nr | observation time | |||
| 24h | 48h | 72h | ||
| I | erythema | 1 | 0 | 0 |
| edema | 0 | 0 | 0 | |
| II | erythema | 1 | 0 | 0 |
| edema | 0 | 0 | 0 | |
| III | erythema | 1 | 1 | 0 |
| edema | 0 | 0 | 0 | |
| IV | erythema | 2 | 1 | 0 |
| edema | 0 | 0 | 0 | |
| V | erythema | 1 | 1 | 1 |
| edema | 0 | 0 | 0 | |
| VI | erythema | 1 | 0 | 0 |
| edema | 0 | 0 | 0 | |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Test substance is determined as not irritating to rabbit skin. The substance caused weak erythema in all animals at the 24-hour evaluation. All signs of irritation were fully reversible within the 72 h observation period in 5/6 animals. In one rabbit slight reddening (score 1) was still present at the last observation time, 72 hours after exposure. However, there is no question that this slight reddening would have been reversed within the maximum possible observation period of 21 days to meet the standards of OECD test guideline 404.
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