Dipotassium hydrogen citrate

Endpoint summary

Description of key information

Based on the available data the test item is not sensitising.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Remarks:

existing human data and experience

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Qualifier:

equivalent or similar to guideline

Guideline:

other: Human Repeat Insult Patch Test (HRIPT)

GLP compliance:

no

Type of study:

patch test

Justification for non-LLNA method:

Human data are available from a human patch test. Thus no LLNA test is necessary.

Species:

other: human

Route:

epicutaneous, semiocclusive

Vehicle:

other: cuticle cream

Concentration / amount:

4%

Day(s)/duration:

21 d

Adequacy of induction:

not specified

Details on study design:

HRIPT; semi-occlusive patches applied 3x/wk for 3 wks; a challenge patch was applied after 2 wks.

Key result

Reading:

1st reading

Group:

test chemical

Dose level:

4%

No. with + reactions:

0

Total no. in group:

56

Interpretation of results:

GHS criteria not met

Conclusions:

Based on several studies on citric salts and organic citrate derivatives the CIR Expert Panel concludes the following:
Alkyl derivatives of citric acid might have sensitising properties as the study results are ambigous.
Metal citrates do only have to be considered to be sensitising if caused my the metal moiety of the substance. As alkali metal ions are nonb as non sensitising, those metal salt containing only sodium, potassium and hydrogen can be stated as not sensitising.

Executive summary:

The assessment report states regarding citric salts and compounds:

In sensitization testing, a cuticle cream containing 4% citric acid was not an irritant or a sensitizer in humans.

2.5% aq. citric acid produced positive results in skin prick test in 3 of 91 urticaria or anigoedema patients.

Triethyl citrate, applied undiluted during epidermal induction, was a strong sensitizer in a guinea-pig maximization test, but 20% in pet. was not a primary irritant or sensitizer in human studies.

Trioctyldodecyl citrate was a mild sensitizer in a local lymph node assay when applied neat, but the same concentration was not an irritant or sensitizer in human studies.

Tributyl citrate (concentration not stated) was not a sensitizer in animal studies.

In human studies, 25% tristearyl citrate and 100%  triisostearyl citrate were not irritants or sensitizers in repeated insult patch tests.

Reference 2

Endpoint:

skin sensitisation: in vitro

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)