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:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (respiratory tract)
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:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Reactive Blue 250 has low oral toxicity with a LD50 > 5000 mg/kg bw and has no skin or eye irritating effects. Likewise, the structural analogue Reactive Black 5 does not have any local irritating or sensitizing effects in animals. Furthermore, Reactive Black 5 did not show any adverse effects in the respiratory sensitisation study. However, respiratory symptoms and/or eczema and urticaria have been reported for highly exposed workers. As no threshold for this effect is available, calculation of local DNELs or inhalation DNELs from animal data seemed not to be reasonable.

Due to the effects reported in highly exposed workers with Reactive Black 5, Reactive Blue 250 is classified as skin sensitising agent (R43 according to Directive 67/548/EEC and Cat 1 / H317 according to Regulation 1272/2008/EC) and respiratory sensitizer (R42 according to Directive 67/548/EEC and Cat 1 / H334 according to Regulation 1272/2008/EC). Based on existing occupational exposure data in textile manufacturing workers, the operation conditions and risk management measures indicated in the respective chapters of this CSR are appropriate and sufficient for controlling the risks.

 

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:
low hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (respiratory tract)
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:
low hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

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

Reactive Blue 250 has low oral toxicity with a LD50 > 5000 mg/kg bw and has no skin or eye irritating effects. Likewise, the structural analogue Reactive Black 5 does not have any local irritating or sensitizing effects in animals. Furthermore, Reactive Black 5 did not show any adverse effects in the respiratory sensitisation study. However, respiratory symptoms and/or eczema and urticaria have been reported for highly exposed workers. As no threshold for this effect is available, calculation of local DNELs or inhalation DNELs from animal data seemed not to be reasonable.

Due to the chemical reaction of the dye with the cotton during the dyeing process, Reactive Blue 250 is covalently bound to the textile. It is therefore unlikely that the consumer is exposed to the dye from contact to the dyed textile. For home-dyeing, consumer use is restricted to dyeing with the washing machine (closed system). The preparation provided for home-dyeing is designed in a way that exposure of the consumer to the powder can be excluded. A consumer exposure to Reactive Blue 250 can therefore be excluded.