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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

No data are available on the skin sensitizing properties of the target substance. This endpoint is filled by read across. In short, for citric acid the available data in public sources have been reviewed. For the ammonium part, a GPMT study is available. It was furthermore considered that ammonium and citric acid are ubiquitous in the human body. Therefore it is scientifically valid to conclude that ammonium dihydrogen citrate in water is not sensitizing.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
See the attached read-across document in section 13.
Reason / purpose for cross-reference:
read-across source
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
2
Total no. in group:
20
Remarks on result:
other: minimal erythema was observed in 2 animals
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: minimal erythema was observed in 1 animal
Reading:
other:
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
GHS criteria not met
Remarks:
In accordance with Regulation (EC) No. 1272/2008 and its amendments.
Conclusions:
Based on the results of ammonium chloride in a skin sensitisation study with guinea pigs (GPMT), ammonium dihydrogen citrate is considered not to be a skin sensitizer. This result is read across to ammonium dihydrogen citrate.
Executive summary:

A guinea pig maximisation test was performed, according to EPA guideline and GLP, to assess the skin sensitising potential of ammonium chloride. 30 female guinea pigs, 20 for the test group and 10 for the control group, were used. The study consisted of an induction phase and a challenge phase. In the induction phase intradermal injections as well as topical application in the shoulder region were given. For the intradermal injections, a concentration of 5 % (v/v) of the substance was used, whereas in the topical application a concentration of 25% (v/v) was used. In the challenge phase the substance was only applied occlusively on the skin in the left flank at a concentration of 10% (v/v). Results of the challenge phase showed minimal erythema in 2 out of 20 animals in the test group 24 hours after application of the substance. 48 hours after application of the substance, 1 out of 20 animals in the test group showed minimal erythema. No oedema was observed in any of the animals. No clinical abnormalities were observed and bodyweight gain was normal during the study. This result is read across to ammonium dihydrogen citrate.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

No data are available on the skin sensitizing properties of the target substance. This endpoint is filled by read across. In short, citric acid is used in cosmetic product, with 6795 reported uses at concentrations up to 4% in leave-on formulations, 10% in rinse-off formulations, and 39% in products diluted for (bath) use. In a review by the CIR Expert Panel, several reports are mentioned in which citric acid was shown not to be sensitizing in human volunteers. In combination with its wide dispersive use and the lack of case reports on sensitizing effects, it is concluded that citric acid is not expected to have sensitizing properties. A guinea pig maximisation test was performed, according to EPA guideline and GLP, to assess the skin sensitising potential of ammonium chloride. 30 female guinea pigs, 20 for the test group and 10 for the control group, were used. The study consisted of an induction phase and a challenge phase. In the induction phase intradermal injections as well as topical application in the shoulder region were given. For the intradermal injections, a concentration of 5 % (v/v) of the substance was used, whereas in the topical application a concentration of 25% (v/v) was used. In the challenge phase the substance was only applied occlusively on the skin in the left flank at a concentration of 10% (v/v). Results of the challenge phase showed minimal erythema in 2 out of 20 animals in the test group 24 hours after application of the substance. 48 hours after application of the substance, 1 out of 20 animals in the test group showed minimal erythema. No oedema was observed in any of the animals. No clinical abnormalities were observed and bodyweight gain was normal during the study. Based on the results of this study it is concluded that the ammonium part of ammonium dihydrogen citrate is not expected to have skin sensitizing properties.

In this regard, it was furthermore considered that ammonium and citric acid are ubiquitous in the human body. Therefore it is scientifically valid to conclude that ammonium dihydrogen citrate is not sensitizing.

Taken all information together, it is concluded that there are no indications that ammonium dihydrogen citrate has sensitizing properties. Therefore the substance is not classified and further tests are waived.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the current data-set, the substance is not classified as a skin sensitizer according to Regulation (EC) No. 1272/2008 and its amendments.