Registration Dossier
Registration Dossier
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EC number: 946-014-9 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: This study was carried out to comply with US EPA-FIFRA guidelines at the time and carried out by the US Food and Drug Laboratories to GLP.
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- 12179-04-3
- Cas Number:
- 12179-04-3
- IUPAC Name:
- 12179-04-3
- Details on test material:
- - Name of test material: Sodium tetraborate pentahydrate
- Physical state: White powder
- Analytical purity: > 99 %
- Lot/batch No.: USB-12-84
- Stability under test conditions: Stable
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: LaCrosse Industries Inc.
- Age at study initiation: Young adults
- Weight at study initiation: 2.13 – 2.45 kg
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: Clipped
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- 0.5 g of test substance was moistened with 0.5 mL physiological saline.
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 6 males
- Details on study design:
- TEST SITE
- Area of exposure: Two areas on the back of each rabbit were treated.
- % coverage: No data
- Type of wrap if used: No data
REMOVAL OF TEST SUBSTANCE
- Washing: the test substance was removed using a moistened towel.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize, 1959
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: Not specified
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: Not specified
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritant / corrosive response data:
- No adverse effects were seen.
- Other effects:
- No data
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- Skin irritation study carried out on disodium tetraborate pentahydrate to comply with US EPA-FIFRA guidelines at the time and carried out by the US Food and Drug Laboratories to GLP showed no irritancy was observed.
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