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EC number: 939-992-3 | CAS number: 1195028-55-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- similar to OECD 404, non-GLP
- GLP compliance:
- no
Test material
- Reference substance name:
- pentalithium(1+) pentasodium 2-[(1E)-2-{2-sulfonato-4-[(1E)-2-{3-sulfonato-4-[(1E)-2-{2-sulfonato-4-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]phenyl}ethenyl]phenyl}diazen-1-yl]phenyl}ethenyl]-5-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]benzene-1-sulfonate 2-[(1E)-2-{2-sulfonato-4-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]phenyl}ethenyl]-5-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]benzene-1-sulfonate
- EC Number:
- 939-992-3
- Cas Number:
- 1195028-55-7
- Molecular formula:
- Molecular formula of the main constituents: (1) C38H28N8O12S4.xLi.xNa (2) C52H38N10O18S6.xLi.xNa
- IUPAC Name:
- pentalithium(1+) pentasodium 2-[(1E)-2-{2-sulfonato-4-[(1E)-2-{3-sulfonato-4-[(1E)-2-{2-sulfonato-4-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]phenyl}ethenyl]phenyl}diazen-1-yl]phenyl}ethenyl]-5-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]benzene-1-sulfonate 2-[(1E)-2-{2-sulfonato-4-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]phenyl}ethenyl]-5-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]benzene-1-sulfonate
- Test material form:
- other: liquid
- Details on test material:
- - Lot/Batch No: 2619427
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Authorized distributor
- Housing: stainless individual cage
- Diet (e.g. ad libitum): 150g/day of special diet for experimental rabbits
- Water (e.g. ad libitum): automatic ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +- 2
- Humidity (%): 55 +- 25
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Lot/batch no. (if required): 2619427 - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 6 square centimeter
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: 4 hours
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
Any other information on results incl. tables
Erythema and Eschar Formation
No erythema ......................................................................................................................... 0
Very slight erythema (barely perceptible) ................................................................................ 1
Well defined erythema ............................................................................................................ 2
Moderate to severe erythema ................................................................................................. 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) ............................ 4
Total possible erythema score 4
Edema formation
No edema .............................................................................................................................. 0
Very slight edema (barely perceptible) .....................................................................................1
Slight edema (edges of area well defined by definite raising) ..................................................... 2
Moderate edema (raised appoximately 1mm) .......................................................................... 3
Severe edema (raised more than 1mm and extending beyond area of exposure) ....................... 4
Total possible edema score 4
Weight table
| Rabbit | Weight (g) |
| N° 1 | 2462 |
| N° 2 | 2492 |
| N° 3 | 2567 |
Mean valours of Erithemas and Edemas observed in rabbits after 1, 24, 48 and 72 h of application
| Mean score of Erithema | Mean score of Edema | |
| Rabbit N° 1 | 0.67 | 0.00 |
| Rabbit N° 2 | 0.67 | 0.00 |
| Rabbit N° 3 | 0.67 | 0.00 |
| All | 0.67 | 0.00 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Any of the rabbits treated with the substance has showed an erythema scored or edema score >=2. According to the test conditions the tested substance is not classified as skin irritant.
- Executive summary:
3 New Zealand white rabbit were dosed with 0.5g or 0.5ml of solid samples or liquid samples respectively of substance. After 4 hours of exposure period the test material was removed with water or appropiate solvent and after 1, 24, 48 and 72 hours the animals were observed.
The sample is considered not irritating due to neither acute erithemas nor edemas are not seen in the animals after the substance is applied.
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