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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Administered by administration under a sleeve of rubber snugly fastened about the clipped trunk of the test animal. Animals were immobilized for 24 hours immediately following treatment. At the end of the exposure period the sleeves were removed and the animals returned to cages for a 2 week observation period.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Sodium Borohydride period
- Physical state: powder
- Purity: 97%
- Lot/batch No.: 3-97

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Housing: individual screen bottom cages
- Weight at study initiation: 2951 - 3980 g
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: clipped trunk
- % coverage: not reported
- Type of wrap if used: rubber sleeve


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
- Time after start of exposure: 24 hours


TEST MATERIAL- no data



VEHICLE no vehicle
Duration of exposure:
24 hours
Doses:
1, 2, 4 and 8 g/kg
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: body weight initially and once a week for two weeks
- Necropsy of survivors performed: no
Statistics:
not reported

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
>= 4 000 - <= 8 000 mg/kg bw
Mortality:
One animal died at 2000 mg/kg but this was not treatment related. All animals at 8000 mg/kg died on Day 1.
Clinical signs:
Skin at all application sites was completely scabbed at 24 hours with this condition still present at 14 days.
Body weight:
no effects
Gross pathology:
not applicable
Other findings:
not applicable

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 is between 4000 and 8000 mg/kg