Registration Dossier
Registration Dossier
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EC number: 282-850-4 | CAS number: 84434-51-5
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)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Hexasodium 6,13-dichloro-3,10-bis[[2-[[4-chloro-6-[(2,4-disulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]ethyl]amino]triphenodioxazine-4,11-disulphonate
- EC Number:
- 282-850-4
- EC Name:
- Hexasodium 6,13-dichloro-3,10-bis[[2-[[4-chloro-6-[(2,4-disulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]ethyl]amino]triphenodioxazine-4,11-disulphonate
- Cas Number:
- 84434-51-5
- Molecular formula:
- C40H30Cl4N14O20S6.6Na
- IUPAC Name:
- hexasodium 6,13-dichloro-3,10-bis({[2-({4-chloro-6-[(2,4-disulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)ethyl]amino})-5,12-dioxa-7,14-diazapentacene-4,11-disulfonate
- Test material form:
- other: presscake
- Details on test material:
- Reactive Blue 198
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g, with 0.4 mL of deionised water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- examination after 30-60 minutes, 1, 2 and 3 days after removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Preparation: about 24h before the start of the study the hair in the dorsal region on the body was removed with an electric clipped. Only animals with intact skin were used.
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: surgical gauze, covered by a piece of impermeable rubber sheeting, secured with adhesive impermeable polyethylene tape
REMOVAL OF TEST SUBSTANCE
- washing: yes, with warm tap water
- Time after start of exposure: after 4 hours
SCORING SYSTEM: according to the score of Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: blue staining
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No signs of systemic toxicity were observed during the 72 hours of observation
- Other effects:
- blue staining
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In the experimental conditions described by OECD guideline 404 for evaluation of the acute dermal irritation / corrosivity of the substance Reactive Blue 198 is detemined to be not irritating to the skin.
- Executive summary:
About 24 hours before the start of the study the hair in the dorsal region of the body of 3 rabbits was removed with an electric clipper. Only animals with intact skin were used.
Each animal was treated with 0.5 g Reactive Blue 198 pasted with 0.4 mL deionised water. The substance was applied over the whole surface of a 2.5 x 2.5 cm covered by surgical gauze and a piece of impermeable rubber sheeting, secured with adhesive impermeable polyethylene tape
The exposure period was 4 hours. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.
Examinations of the skin took place after 30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches.
Erythema and oedema were evaluated numerically according to the score of DRAIZE. All other changes of the skin were recorded.
No signs of irritation occurred during the whole study.
The skin of the animals was discoloured blue 3 after removal of the patches up to the end of the study.
Testing of Reactive Blue 198 for primary dermal irritation in the rabbit showed, that the substance is not irritating to skin.
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