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Registration Dossier
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EC number: 440-050-4 | CAS number: 243857-97-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From Jul. 06, 1999 to Oct. 14, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 440-050-4
- EC Name:
- -
- Cas Number:
- 243857-97-8
- Molecular formula:
- Hill formula: C23H(19-x-y)ClLixN8NayO14S4 (x+y=3), x and y > 0
- IUPAC Name:
- lithium(1+) disodium 2-{[4-chloro-6-(cyanoamino)-1,3,5-triazin-2-yl]amino}-5-hydroxy-6-(2-{2-methoxy-5-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)naphthalene-1,7-disulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Reaktiv Orange DYPR 1466
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, 88353 Kiβlegg
- Weight at study initiation: 2.2 - 2.6 kg
- Diet: ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water: water from automatic water dispensers, ad libitum
- Acclimation period: 1 wk
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3 °C
- Humidity (%): 50±20 °C
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light
IN-LIFE DATES: From: Jul. 06, 1999 To: Jul. 13, 1999
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 (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 g of test substance pasted with 0.5 mL deion. water
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 24, 48 and 72 h after removal of the patches, additional readings were performed after 7 d
- Number of animals:
- Three
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal region of the body
- % coverage: 25 cm2
- Type of wrap if used: Yes, The test substance was evenly distributed over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with warm water
- Time after start of exposure: 4 h
SCORING SYSTEM: Erythema, eschar formation and edema were evaluated numerically according to the score of DRAIZE
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No abnormalities detected in any of the tested animals at time points till 72 h
- Other effects:
- No signs of irritations were observed during the whole observation period
30 - 60 min up to 72 h after decontamination the skin of two animals showed an orange discoloration. 7 d after decontamination all discoloration were disappeared.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test substance was considered to be non-irritating to rabbit skin
- Executive summary:
A study was conducted to assess the skin irritation potential of test substance to the rabbit skin according to EU Method B.4. and OECD Guideline 404 in compliance with GLP.
Three animals were treated with 0.5 g of the test substance pasted with 0.5 mL deionised water using semi-occlusive patches for 4 h. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water. The skin was evaluated for erythema, eschar formation and edema numerically according to the score of Draize system for up to 72 h after patch removal and additionally for 7 d.
No signs of irritation were observed during the whole observation period.30 - 60 min up to 72 h after decontamination the skin of two animals showed an orange discolouration and this discolouration disappeared 7 d after decontamination.
Under the test conditions, the test substance was considered to be non-irritating to rabbit skin.
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