Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

No relevant toxic effects occurred after oral administration or after administration to skin or mucous membranes. The test substance is not subject to classification for skin, eye irritation and sensitization. No adverse effects observed up to the highest dose tested were observed in the repeat dose study.

Due to the chemical reaction of the dye with the cotton during the dyeing process, the test substance is covalently bound to the textile. It is therefore unlikely that the consumer is exposed to the dye from contact to the dyed textile. Hence no risk of dermal or inhalational exposure for consumers arises from the dye by use of the final product.

For consumer use ‘Home-Dyeing’ the dyeing procedure is limited to dyeing in a closed system (washing machine). Potential consumer exposure is minimised by the mode of application, use conditions (a washing machine is charged with the closed package) and safeguarded by the type of packaging (no opening/open handling of the dye preparation). The preparations for home-dyeing are either liquid formulations or ready-to-use solid preparations which do not allow exposure to the dye (e.g. sheath that is dissolved in the washing machine). Users from the general population are protected from any contact by the use of packaging that is not opened but directly charged into the washing machine when textiles are dyed at home. There is no open handling of the product. In addition, the use instructions provided with the textile dyes explicitly recommend the use of gloves and skirting for manual use of textile dyes. The consumers are anticipated to use at least gloves (supplied with the dye) to avoid staining of the hands. No exposure is expected to occur during normal use and handling during home dyeing.