Registration Dossier
Registration Dossier
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EC number: 241-004-4 | CAS number: 16940-66-2
Endpoint summary
Administrative data
Description of key information
The RD50 in mice after single exposure was determined to be 0.44 mg/l. See endpoint study record in IUCLID section 7.9.3 (Hilaski 2001).
There is evidence from animal experiments that sodium borohydride irritates the respiratory tract. However, no human data are available, which would be the basis for classification according to CLP 3.8.2.2.1.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- 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
- 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).
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Animals were placed in a collar. The test substance was instilled in one eye, the other untreated eye served as a control. Scoring was at 24, 48 and 72 hours after instillation and any residue of the test material and accumulated discharge was flushed from the eye each time they were scored.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Not reported
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
- Concentration (if solution): n/a
VEHICLE- no vehicle - Duration of treatment / exposure:
- Residue was flushed from the eye each time they were scored. Eyes were completely destroyed by 24 hours.
- Observation period (in vivo):
- Eyes were completely destroyed by 24 hours.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): residue and accumulated discharge was flushed at each reading
- Time after start of exposure: 24 hours
SCORING SYSTEM: read according to the scale of scoring for damage to the cornea, iris and bulbar and palpebral conjunctivae
TOOL USED TO ASSESS SCORE: not reported - Irritation parameter:
- other: Eye completely destroyed by 24 hours
- Basis:
- mean
- Time point:
- other: 24 h
- Reversibility:
- not reversible
- Remarks on result:
- other: No scores reported. Eyes completely destroyed by 24 hours
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Eye were completely destroyed by 24 hours post dose.
Reference
Eyes completely destroyed by 24 hours. Protein of eye appeared to be completely denatured.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Contact of sodium borohydride with water content of either skin or eyes would be anticipated to cause release of hydrogen and generation of heat. Tissue destruction was observed in both dermal LD50 and eye irritation tests confirming this response. Tissue destruction was long lasting and had not been repaired by the completion of these studies.
Justification for selection of skin irritation / corrosion endpoint:
Klimisch score 1
Justification for selection of eye irritation endpoint:
Klimisch score 1
Effects on skin irritation/corrosion: corrosive
Effects on eye irritation: corrosive
Justification for classification or non-classification
The test substance is corrosive. Tissue destruction was long lasting and had not been repaired by the completion of acute dermal and eye irritation studies. The substance is classified as Category 1C for skin and Category 1 for eyes according to GHS.
Human data to evaluate respiratory tract irritation according to CLP 3.8.2.2.1 is not available.
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