Registration Dossier
Registration Dossier
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EC number: 278-674-2 | CAS number: 77365-64-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From December 21, 1993 to February 02, 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Pentasodium 2-[[8-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-1-hydroxy-3,6-disulphonato-2-naphthyl]azo]naphthalene-1,5-disulphonate
- EC Number:
- 278-674-2
- EC Name:
- Pentasodium 2-[[8-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-1-hydroxy-3,6-disulphonato-2-naphthyl]azo]naphthalene-1,5-disulphonate
- Cas Number:
- 77365-64-1
- Molecular formula:
- C31H19ClN7Na5O19S6
- IUPAC Name:
- pentasodium 2-[[8-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-1-hydroxy-3,6-disulphonato-2-naphthyl]azo]naphthalene-1,5-disulphonate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Supplier: association of breeders in Hadrce Kralovè
- Weight: 2,5 Kg (prior the application)
- Health status: checked frorm parasite and patogen microrganisms, viruses and fungi
- Housing: acclimatized cages ( Velaz Praha)
- Selection: 6 animals pro cage by gender
- Identification: by number on cages door
- Diet: KO-16 (Velaz Praha),
- Water: ad libitum, according to SN 757111
- Cleaning: disinfection of cages
- Acclimatization: quarantine
- Acclimatization period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature : 20 ± 3 °C
- Humidity: 50 ± 15 %
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abraded
- Vehicle:
- water
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1 hour, 24, 48, 72 hours
- Number of animals:
- 3
- Details on study design:
- DOSAGE PREPARATION: By Mettler AE 200
TEST SITE: Left and right side of the lateral surface of the abdominal area, located in epigastrium, mesogastrium, hypogastrium. Scarification of the area was performed. Area: 6x6 cm.
APPLICATION: Gauze, aluminum foil and cellulose wadding
DRESSING: Bandage
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Not evaluated
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Not evaluated
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Non irritating for the skin
- Executive summary:
Method
The substance was tested for irritation to the skin in rabbit, White New Zealand strain, according to OECD 404.
0.5 grams of the substance were applied on intact and abraded skin and reactions (erhythema and edema) were observed for 72 hours.
Clinical signs were also observed and primary irritation score and the degree of dermal irritation were evaluated.
Conclusion
After 72 hours of observation the registering substance was considered non irritant for the skin.
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