Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2007

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
Maleic acid
EC Number:
203-742-5
EC Name:
Maleic acid
Cas Number:
110-16-7
Molecular formula:
C4H4O4
IUPAC Name:
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

Conclusions:
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.