Sodium tetrahydroborate

Skin sensitisation

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

Test material information

Constituent 1

Reference substance name:

Sodium tetrahydroborate

EC Number:

241-004-4

EC Name:

Sodium tetrahydroborate

Cas Number:

16940-66-2

Molecular formula:

BH4.Na

IUPAC Name:

Sodium tetrahydridoborate(1–)

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)

Induction

Induction 1

Route:

intradermal

Vehicle:

physiological saline

Induction 2

Concentration / amount:

0.01% solution

Challenge

Challenge 1

Route:

intradermal

Vehicle:

physiological saline

Challenge 2

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 chemical

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.