Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

repeated dose toxicity: other route
other: Safety Assessment Evaluation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well document literature review on maleic acid

Data source

Reference Type:

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
Maleic acid
EC Number:
EC Name:
Maleic acid
Cas Number:
Molecular formula:
but-2-enedioic acid
Details on test material:
Maleic Acid (CAS no. 110-16-7 and 6915-18-0) is a cis unsaturated organic acid.

Results and discussion

Results of examinations

Details on results:
Maleic Acid at the use levels is not expected to produce dermal or systemic toxicity.

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

see executive summary

Applicant's summary and conclusion

Authors concluded that maleic acid is safe for use in cosmetic formulations as a pH adjuster.
Executive summary:

Maleic acid is used in cosmetics as a pH adjuster and an ingredient in fragrances and non-cosmetic. Other uses include artificial resins, dyeing, and finishing wool, cotton, and silk, in salts of antihistamines, and as preservative for oils and fats. Animal toxicity data reported nephrotoxicity in rats and dogs associated with maleic acid injection. Data showed that maleic acid induce Fanconi syndrome in rats and dogs. Maleic Acid at the use levels is not expected to produce dermal or systemic toxicity.