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

The test substance is synthesized and handled in an aqueous potassium hydroxide solution (pH 13) under inert gas atmosphere to avoid oxidation to indigo which is practically insoluble in water. It is instable in an aqueous phase at neutral pH or as solid material on air and oxidises rapidly to indigo (CAS number 482-89-3). The tests presented in the toxicity section are therefore either performed with preparations of leucoindigo or leucoindigo-salts which were prevented from oxidation or, in majority, with the oxidised substance, i.e., indigo. As risk assessment is hence mainly based on the studies with indigo, we refer to the Risk Assessment in the indigo registration (REACH registration number 01-2119488933-22-0000).  

 

As no adverse effects were observed with either leucoindigo or indigo, no DNELs were derived for the registered substance in its theoretical solid salt form. The only adverse effects observed were local effects due to potassium hydroxide, which was present in different formulations to prevent oxidation. As local irritation or corrosion due to the stabiliser potassium hydroxide can be expected, we

refer to the Risk Assessment in the potassoum hydroxide registration (REACH registration number 01-2119487136-33-0000).

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

Consumers are not exposed to the registered substance. The test substance is only for industrial use. The use of the test item results in products containing the oxidised form indigo (EC number 207-586-9). Hence we refer to the Risk Assessment in the indigo registration (REACH registration number 01-2119488933-22-0000). The following discussion for Consumer Use is taken from the Toxicological Summary of the Lead Dossier for indigo.

Indigo as defined by the sameness criteria did not show any adverse systemic or local effects either during short-term or long-term exposure. Hence, there is no hazard for the consumer during use of the respective articles.