Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Data waiving: Study scientifically unjustified as the test substance is used in humans for so many years as a safely cosmetic. The FDA approval 21CFR Part 73.2775 for the substance covers externally applied skin contact cosmetics including lipsticks and those used in the area of the eye; no certification is necessary. It is also listed under reference no. 18 in Annex III part 2 (d) of the EEC Directive 76/768/EEC as a pigment which may be used without restriction.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
Study scientifically unjustified as the test substance is used in humans for so many years as a safely cosmetic. The FDA approval 21CFR Part 73.2775 for the substance covers externally applied skin contact cosmetics including lipsticks and those used in the area of the eye; no certification is necessary. It is also listed under reference no. 18 in Annex III part 2 (d) of the EEC Directive 76/768/EEC as a pigment which may be used without restriction.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
Study scientifically unjustified as the test substance is used in humans for so many years as a safely cosmetic in the area of the eyes. The FDA approval 21CFR Part 73.2775 for the substance covers externally applied skin contact cosmetics including lipsticks and those used in the area of the eye; no certification is necessary. It is also listed under reference no. 18 in Annex III part 2 (d) of the EEC Directive 76/768/EEC as a pigment which may be used without restriction.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Study scientifically unjustified as the test substance is used in humans for so many years as a safely cosmetic. The FDA approval 21CFR Part 73.2775 for the substance covers externally applied skin contact cosmetics including lipsticks and those used in the area of the eye; no certification is necessary. It is also listed under reference no. 18 in Annex III part 2 (d) of the EEC Directive 76/768/EEC as a pigment which may be used without restriction.

Justification for selection of skin irritation / corrosion endpoint:

Study scientifically unjustified as the test substance is used in humans for so many years as a safely cosmetic. The FDA approval 21CFR Part 73.2775 for the substance covers externally applied skin contact cosmetics including lipsticks and those used in the area of the eye; no certification is necessary. It is also listed under reference no. 18 in Annex III part 2 (d) of the EEC Directive 76/768/EEC as a pigment which may be used without restriction.

Justification for selection of eye irritation endpoint:

Study scientifically unjustified as the test substance is used in humans for so many years as a safely cosmetic in the area of the eyes. The FDA approval 21CFR Part 73.2775 for the substance covers externally applied skin contact cosmetics including lipsticks and those used in the area of the eye; no certification is necessary. It is also listed under reference no. 18 in Annex III part 2 (d) of the EEC Directive 76/768/EEC as a pigment which may be used without restriction.

Justification for classification or non-classification

Based on the available data, the substance is not classified as irritating.

Categories Display