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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: case report

Data source

Reference
Reference Type:
publication
Title:
Contact dermatitis to yellow iron oxide.
Author:
Zugermann C
Year:
1985
Bibliographic source:
Contact Dermatitis 13, 107-109

Materials and methods

Study type:
clinical case study
Endpoint addressed:
skin sensitisation

Test material

Constituent 1
Reference substance name:
20344-49-4
Cas Number:
20344-49-4
IUPAC Name:
20344-49-4
Constituent 2
Reference substance name:
Iron hydroxide oxide
EC Number:
243-746-4
EC Name:
Iron hydroxide oxide
IUPAC Name:
243-746-4
Constituent 3
Reference substance name:
Iron hydroxide oxide
IUPAC Name:
Iron hydroxide oxide

Method

Subjects:
43-old non atopic white female
Reason of exposure:
intentional
Exposure assessment:
not specified

Results and discussion

Any other information on results incl. tables

The reaction to yellow iron oxide in this patient was significant while no reaction occurred in 10 normal controls.

No other case of yellow iron oxide dermatitis has been reported to occur as a result of its use as a pigment in an eyelid cosmetic.

It is unlikely that many additional cases such as the one reported here will occur, considering the large quantity of this material which thus far has been used without incident.

Applicant's summary and conclusion

Executive summary:
After epicutan patch testing, a 43-year-old non-atopic, white female with eyelid dermatitis was found to be positive to yellow iron oxid used as a dye in her mascara. Yellow iron oxide, also known as limonite (alpha-FeOOH) or yellow ochre, is a common cosmetic dye.