Registration Dossier

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
Reference
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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
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

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
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).
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
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

Eyes completely destroyed by 24 hours. Protein of eye appeared to be completely denatured.

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Eye were completely destroyed by 24 hours post dose.
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.