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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation
Remarks:
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

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The hair was removed from the back and flank areas as often as necessary. A solution was injected intracutaneously every other day until a total of 10 had been made. injections were made in the area of the flanks. Two weeks after the tenth injection, a retest injection was made. Twenty-four hours later readings were made.
GLP compliance:
no
Type of study:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Sodium borohydride
- Lot/batch No.: 3-117

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: not reported
- Age at study initiation: not reported
- Weight at study initiation: 300-400 g

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
0.01% solution
Challengeopen allclose all
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
0.01% solution
No. of animals per dose:
10
Details on study design:
RANGE FINDING TESTS: not applicable


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: retest was done 2 weeks following the tenth injection.
- Test groups: one
- Control group: none
- Site: flank
- Frequency of applications: every other day
- Concentrations: 0.1 mL of a 0.01% solution


B. CHALLENGE EXPOSURE
- No. of exposures: 10
- Day(s) of challenge: 14-day
- Exposure period: retest was done 2 weeks following the tenth injection
- Test groups: one
- Control group: none
- Site: flank
- Concentrations: 0.05 mL of a 0.01% solution
- Evaluation (hr after challenge): 24 hr


Challenge controls:
none
Positive control substance(s):
not specified

Results and discussion

Positive control results:
not applicable

In vivo (non-LLNA)

Results
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
0.1 mL
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
not reported
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 mL. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: not reported.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Twenty-four hours after the 14-day challenge application the skin sensitization score was zero.