Registration Dossier
Registration Dossier
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EC number: 241-004-4 | CAS number: 16940-66-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
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:
- other: United Nations and US Department of Transportation Packing Group Classification guidelines for Class 8 materials
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sodium tetrahydroborate
- EC Number:
- 241-004-4
- EC Name:
- Sodium tetrahydroborate
- Cas Number:
- 16940-66-2
- Molecular formula:
- BH4.Na
- IUPAC Name:
- Sodium tetrahydridoborate(1–)
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): 15% sodium borohydride in dimethyl acetamide
- Physical state: liquid
- Lot/batch No.: MLK-58-9; TD No. 01-002
- Name of test material (as cited in study report): 15% sodium borohydride in N-methyl pyrrolidone
- Physical state: liquid
- Lot/batch No.: MLK-58-10; TD No. 01-003
- Name of test material (as cited in study report): 7.5% sodium borohydride in tri(ethylene glycol) dimethyl ether
- Physical state: liquid
- Lot/batch No.: MLK-58-14; TD No. 01-004
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: as received in solvent
- Controls:
- not specified
- Duration of treatment / exposure:
- 4-hour, 1-hour, 3 minute
- Observation period:
- 72-hours after patch removal
- Number of animals:
- 12
Results and discussion
Any other information on results incl. tables
15% Sodium borohydride in dimethyl acetamide- 4 hour exposure
| Erythema | Time after patch removal |
|||
| Animal number | 1 hr | 24 hr | 48 hr | 72 hr |
| 00 -27286 | 4 blanching; green/black | 4 concave eschar | 4 concave eschar | 4 concave eschar |
| Edema | ||||
| Animal number | 1 hr | 24 hr | 48 hr | 72 hr |
| 00 -27286 | 4 pocketing edema | 4 pocketing edema | 4 pocketing edema | 4 pocketing edema |
15% Sodium borohydride in dimethyl acetamide- 1 hour exposure
| Erythema | Time after patch removal |
|||
| Animal number | 1 hr | 24 hr | 48 hr | 72 hr |
| 00 -27295 | 4 dlanching; darkened areas | 4 pocketing edema; blanching; darkened areas; concave eschar | 4 blanching; darkened areas; concave eschar | 4 blanching; darkened areas; concave eschar |
| Edema | ||||
| Animal number | 1 hr | 24 hr | 48 hr | 72 hr |
| 00 -27295 | 4 pocketing edema | 4 pocketing edema | 4 pocketing edema | 4 pocketing edema |
15% Sodium borohydride in dimethyl acetamide- 3 min exposure
| Erythema | Time after patch removal |
|||
| Animal number | 1 hr | 24 hr | 48 hr | 72 hr |
| 00 -27295 | 0 | 0 | 0 | 0 |
| 01 -27127 | 0 | 1 | 0 | 0 |
| 01 -27149 | 1 | 1 | 1 | 0 |
| Edema | ||||
| Animal number | 1 hr | 24 hr | 48 hr | 72 hr |
| 00 -27295 | 0 | 0 | 0 | 0 |
| 01 -27127 | 0 | 0 | 0 | 0 |
| 01 -27149 | 0 | 0 | 0 | 0 |
15% Sodium borohydride in N-methyl pyrrolidone- 4 hour exposure
| Erythema | Time after patch removal | |||
| Animal number | 1 hr | 24 hr | 48 hr | 72 hr |
| 00 -27296 | 4 blanching; green/black | 4 concave eschar | 4 concave eschar | 4 concave eschar |
| Edema | ||||
| Animal number | 1 hr | 24 hr | 48 hr | 72 hr |
| 00 -27296 | 4 pocketing edema | 4 pocketing edema | 4 pocketing edema | 4 pocketing edema |
15% Sodium borohydride in N-methyl pyrrolidone- 1 hour exposure
| Erythema | Time after patch removal | |||
| Animal number | 1 hr | 24 hr | 48 hr | 72 hr |
| 00-27295 | 4 blanching; darkened areas | 4 concave eschar | 4 darkened areas; concave eschar | 4 darkened areas; concave eschar |
| Edema | ||||
| Animal number | 1 hr | 24 hr | 48 hr | 72 hr |
| 00 -27295 | 4 | 4 pocketing edema | 4 pocketing edema | 4 pocketing edema |
15% Sodium borohydride in N-methyl pyrrolidone- 3 min exposure
| Erythema | Time after patch removal | |||
| Animal number | 1 hr | 24 hr | 48 hr | 72 hr |
| 01 -27132 | 0 | 0 | 0 | 0 |
| 01 -27142 | 1 | 1 | 1 | 0 |
| 01 -27159 | 0 | 0 | 0 | 0 |
| Edema | ||||
| Animal number | 1 hr | 24 hr | 48 hr | 72 hr |
| 01 -27132 | 0 | 0 | 0 | 0 |
| 01 -27142 | 0 | 0 | 0 | 0 |
| 01 -27159 | 0 | 0 | 0 | 0 |
7.5% Sodium borohydride in tri(ethylene glycol) dimethyl ether- 4 hour exposure
| Erythema | Time after patch removal | |||
| Animal number | 1 hr | 24 hr | 48 hr | 72 hr |
| 00 -27298 | 4 blanching; green/black | 4 concave eschar | 4 concave eschar | 4 concave eschar |
| Edema | ||||
| Animal number | 1 hr | 24 hr | 48 hr | 72 hr |
| 00 -27298 | 4 pocketing edema | 4 pocketing edema | 4 pocketing edema | 4 pocketing edema |
7.5% Sodium borohydride in tri(ethylene glycol) dimethyl ether- 1 hour exposure
| Erythema | Time after patch removal | |||
| Animal number | 1 hr | 24 hr | 48 hr | 72 hr |
| 00 -27295 | 4 blanching; darkened areas | 4 blanching; darkened areas; concave eschar | 4 darkened areas; concave eschar | 4 blanching; darkened areas; concave eschar |
| Edema | ||||
| Animal number | 1 hr | 24 hr | 48 hr | 72 hr |
| 00 -27295 | 4 pocketing edema | 4 pocketing edema | 4 pocketing edema | 4 pocketing edema |
7.5% Sodium borohydride in tri(ethylene glycol) dimethyl ether- 3 min exposure
| Erythema | Time after patch removal | |||
| Animal number | 1 hr | 24 hr | 48 hr | 72 hr |
| 00 -27297 | 0 | 0 | 0 | 0 |
| 01 -27165 | 1 | 2 | 2 | 1 |
| 01 -27147 | 1 | 1 | 1 | 0 |
| Edema | ||||
| Animal number | 1 hr | 24 hr | 48 hr | 72 hr |
| 00 -27297 | 0 | 0 | 0 | 0 |
| 01 -27165 | 0 | 0 | 0 | 0 |
| 01 -27147 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Draize criteria
- Conclusions:
- Corrosive findings were evident at 4 hours.
Based on United Nations and United States Department of Transportation Packing Group classification criteria for Class 8 materials, each test material would be assigned to Packing Group II: full thickness destruction on intact skin tissue within an observation period up to 14 days starting after an exposure time of more than 3 minutes, but not more than 60 minutes).
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