Registration Dossier

Toxicological information

Skin irritation / corrosion

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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:
2001
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

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).