Potassium tetrahydroborate

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

Endpoint:

skin sensitisation: in vivo (non-LLNA)

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

Justification for type of information:

The study is well documented following general scientific practice.

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

Justification for non-LLNA method:

When the study was conducted, the LLNA-test was not the standard method. As the study is well-documented, it is still considered to be reliable.

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

Positive control results:

not applicable

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

no indication of skin sensitisation

Interpretation of results:

GHS criteria not met

Conclusions:

Twenty-four hours after the 14-day challenge application the skin sensitization score was zero.

Reference 2

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Remarks:

in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given

Justification for type of information:

The tetrahydroborate moiety of the sodium salt is prooved to be non-sensitizing by this study. Potassium cations are known to be non-sensitizing as well. Thus a read-across approach to a reliable experimental study with sodium tetrahydroborate is sufficient to cover this endpoint.

Reason / purpose for cross-reference:

read-across source

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

Justification for non-LLNA method:

When the study was conducted, the LLNA-test was not the standard method. As the study is well-documented, it is still considered to be reliable.

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

Positive control results:

not applicable

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

no indication of skin sensitisation

Interpretation of results:

GHS criteria not met

Conclusions:

Twenty-four hours after the 14-day challenge application the skin sensitization score was zero.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available