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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature

Data source

Reference
Reference Type:
publication
Title:
The results of skin testing with food additives and the effect of an elimination diet in chronic ad recurrent urticaria and recurrent angioedema
Author:
Malanin & Kalimo (1989) as cited in Cosmetic Ingredient Review (2012)
Year:
2012
Bibliographic source:
Cosmetic Ingredient Review, 2012. On the Safety Assessment of Citric Acid, Inorganic Citrate Salts, and Alkyl Citrate Esters as Used in Cosmetics. Report date: March 27, 2012
Report date:
2012

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Not specified
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Citric acid
EC Number:
201-069-1
EC Name:
Citric acid
Cas Number:
77-92-9
Molecular formula:
C6H8O7
IUPAC Name:
2-hydroxypropane-1,2,3-tricarboxylic acid
Details on test material:
No further details of test material are given in the publication

Method

Type of population:
other: patients with chronic urticaria or angioedema
Ethical approval:
not specified
Clinical history:
- History of allergy or casuistics for study subject or populations: not specified
- Symptoms, onset and progress of the disease: Patients with chronic urticaria or angioedema
Controls:
Not specified
Route of administration:
dermal
Details on study design:
A skin prick test was performed on 91 patients with chronic urticaria or angioedema with 2.5 % aq. citric acid as the test substance.

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: not specified

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 3 patients
- Number of subjects with negative reactions: 88 patients

Any other information on results incl. tables

In a skin prick test which was not conducted according to any guideline nor in compliance to GLP, it was observed that the test substance, citric acid, caused positive results in 3 out of 91 patients. Very limited details were given in the study source.

Applicant's summary and conclusion

Conclusions:
In a skin prick test which were not conducted according to any guideline and not in compliance to GLP and with very limited provided details, it was observed that the test substance, citric acid, casued positive results in 3 of 91 patients whereof one of the patients also reacted to benzoic and propionic acids.