Registration Dossier
Registration Dossier
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EC number: 695-988-9 | CAS number: 100556-82-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 10. Nov. to 13. Nov 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study; the tested substance is a precursor or Reactive Black 5 Bis-Vinyl and hydrolyses in aqueous solution from the bis-ester to the bis-vinyl form
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reactive Black 5
- IUPAC Name:
- Reactive Black 5
- Details on test material:
- Preparation of Reactive Black 5: Remazol Schwarz B flüssig 50
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
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.1 - 2.4 kg
- Housing: single
- Diet (ad libitum): Altromin 2123
- Water (ad libitum): deionized chlorated water from automated supply
- Acclimation period: NA
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 10. Nov To: 13. Nov. 1987
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5x2.5 cm²
- Type of wrap if used: semiocclusive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm tap water
- Time after start of exposure: 4 hours
EVALUATION TIME
30-60 minutes, 24, 48, 72 hours after removal of bandage
SCORING SYSTEM: according to test guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 30 to 60 min, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 30 to 60 min, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- no signs of irritation observed
- Other effects:
- light blue staining of test site
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- not irritating
no labelling necessary - Executive summary:
Testing of Remazol Schwarz B 50 flüssig for skin irritation in rabbots according to OECD TG 404 did not lead to any signs of dermal irritation. The test item has not to be classified as skin irritant.
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