Registration Dossier
Registration Dossier
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EC number: 237-360-5 | CAS number: 13762-51-1
Toxicological information
Endpoint summary
Administrative data
Description of key information
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:
- 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
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: score for all solvents tested after an exposure time of at least 1 h to the test material
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: score for all solvents tested after an exposure time of at least 1 h to the test material
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 00 -27286
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- 00 -27295
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- 00 -27296
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- 0 -27298
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 00 -27286
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- 00 -27295
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- 00 -27296
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- 00 -27298
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Interpretation of results:
- Category 1 (corrosive) based on GHS 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). - Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The tetrahydroborate moiety of the sodium salt is prooved to be corrosive by this study. Potassium cations are known to be non-irritating. Thus a read-across approach to a reliable experimental study with sodium tetrahydroborate is sufficient to cover this endpoint.
- Reason / purpose for cross-reference:
- read-across source
- 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
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: score for all solvents tested after an exposure time of at least 1 h to the test material
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: score for all solvents tested after an exposure time of at least 1 h to the test material
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 00 -27286
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- 00 -27295
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- 00 -27296
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- 0 -27298
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 00 -27286
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- 00 -27295
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- 00 -27296
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- 00 -27298
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Interpretation of results:
- Category 1 (corrosive) based on GHS 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).
Referenceopen allclose all
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 |
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
- Justification for type of information:
- The study is well documented following general scientific practice.
- 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:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Eye were completely destroyed by 24 hours post dose.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given
- Justification for type of information:
- The tetrahydroborate moiety of the sodium salt is prooved to be corrosive by this study. Potassium cations are known to be non-irritating. Thus a read-across approach to a reliable experimental study with sodium tetrahydroborate is sufficient to cover this endpoint.
- Reason / purpose for cross-reference:
- read-across source
- 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:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Eye were completely destroyed by 24 hours post dose.
Referenceopen allclose all
Eyes completely destroyed by 24 hours. Protein of eye appeared to be completely denatured.
Eyes completely destroyed by 24 hours. Protein of eye appeared to be completely denatured.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
