Registration Dossier
Registration Dossier
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Reaction mass of pentasodium 2-[(8-{[4-chloro-6-(4-{[2-(sulfonatooxy)ethyl]sulfonyl}anilino)-1,3,5-triazin-2-yl]amino}-1-hydroxy-3,6-disulfonato-2-naphthyl)diazenyl]naphthalene-1,5-disulfonate and pentasodium 2-[(1-hydroxy-8-{[4-hydroxy-6-(4-{[2-(sulfonatooxy)ethyl]sulfonyl}anilino)-1,3,5-triazin-2-yl]amino}-3,6-disulfonato-2-naphthyl)diazenyl]naphthalene-1,5-disulfonate
EC number: 943-998-1 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- in vivo
- Type of information:
- other: read across from analogue substance
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier
Data source
Reference
- Reference Type:
- other: body responsible for the test
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 402-420-3
- EC Name:
- -
- Molecular formula:
- C31H19ClN7Na5O19S6
- IUPAC Name:
- sodium (E)-2-(4-(4-chloro-6-(7-((1,5-disulfonatonaphthalen-2-yl)diazenyl)-8-hydroxy-3,6-disulfonatonaphthalen-1-ylamino)-1,3,5-triazin-2-ylamino)phenylsulfonyl)ethyl sulfate
- 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
- Source: HOECHST AG, Kastengrund
- Age at study initiation: ca 3-5 months
- Weight at study initiation: 2.6-2.9 kg
- Housing: single
- Diet: Altromin 2123, 15 g daily
- Water (ad libitum): deionized, chlorinated water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 50 ± 20 %
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 14.10.1986 To: 17.10.1986
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Remarks:
- 0.3 mL/500 mg to form paste
- Controls:
- no
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4h
- Observation period:
- 72h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 25 cm²
- Type of wrap if used: semiocclusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm tap water
- Time after start of exposure: after 4 hours
SCORING SYSTEM: Draize
30 - 60 minutes, 24, 48 and 72 hours after removal of the test substance
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- 3 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 1
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 1
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 1
Any other information on results incl. tables
Form of application: To the intact, shorn skin in the dorsal region of the trunk (area 25 cm2). Type and duration of the signs of irritation: One hour after the removal of the plaster the skin of the animals revealed hardly perceptible to clearly outlined erythema. Very slight oedema was observed in two animals. 24 to 48 hours after the removal of the plaster the skin still exhibited hardly perceptible erythema. 72 hours after the removal of the plaster, all of the animals were free from signs of irritation.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information under Regulation 1272/2008 Criteria used for interpretation of results: EU
- Conclusions:
- The substance was tested following OECD 404. Under the experimental conditions the substance did not show any skin irritation properties.
- Executive summary:
The substance was tested following OECD 404. Under the experimental conditions the substance did not show any skin irritation properties.
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