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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Effects on fertility

Additional information

A one-generation reproduction toxicity study has been performed in the male Sprague Dawley rat. 0.5 mL of hair dyes, one corresponding to a semi-permanent and the other to an oxidative dye, both containing 2.2% PPD (approximately 11 mg/kg/day) was applied topically to the backs of 25 rats twice a week for 10 weeks. No evidence of reduced fertility was observed (Burnett et al., 1981; see IUCLID section 7.8.1 – Toxicity to reproduction for additional study details). A dermal two-generation reproduction toxicity study has been performed in Sprague Dawley rats with hair dye formulations containing 2%, 3% or 4% PPD were mixed with an equal volume of hydrogen peroxide. No compound-related effects on survival, general appearance, food consumption, body weight gain, fertility of males or females or on gestation, lactation or weaning indices were observed (Burnett and Goldenthal, 1988; see IUCLID section 7.8.1 – Toxicity to reproduction for additional study details). In addition, no adverse effects on reproductive organs or tissues were observed in a 90-day repeated dose oral gavage study (The key study for evaluation of repeated dose toxicity – see IUCLID section 7.5.1 – Repeat dose toxicity: oral). In summary, the studies described above support the proposal to eliminate the necessity of further animal testing and support waiving the need for a two generation reproductive toxicity test.


Short description of key information:
Data waiver provided for 2-generation reproductive toxicity study based on no reproductive effects observed in a dermal 1-generation rat study (oxidative hair dye containing 2.2% PPD) or a dermal 2-generation rat study (hair dye containing 2, 3, or 4% PPD). Details are provided in IUCLID5.

Effects on developmental toxicity

Description of key information
Oral: developmental gavage study in rats (OECD 414) - developmental effects were observed at maternally toxic levels.
Maternal NOEL = 5 mg/kg
Developmental NOEL = 10 mg/kg
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
10 mg/kg bw/day
Additional information

Pregnant female rats were exposed to the test substance via gavage on day 6-19 of gestation at concentrations of 5, 10, and 20 mg/kg. Maternal toxicity was observed at ≥10 mg/kg/day, as evidenced by a transiently lower mean body weight gain. Although not statistically significant, slightly lower gravid uterus weights and mean foetal weights (accompanied by a slightly retarded ossification) were observed at 20 mg/kg. The maternal NOEL was 5 mg/kg/day and the developmental NOEL was 10 mg/kg/day. The test substance was not embrotoxic, fetotoxic, or teratogenic.

Justification for classification or non-classification

The test substance did not adversely affect reproductive organs and was not uniquely toxic to the developing foetus. The substance does not need to be classified for reproductive toxicity according the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

Additional information