Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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

Worker DNELs have not been derived for pigment additive RL because the substances did not cause relevant toxictiy in any test performed according to the information requirements.

In particular

- pigment additiv RL is a chemically unreactive substance,

- pigment additiv RL can be considered insoluble in water and only slightly soluble in n-octanol or fat.

- due to its low solubility, it is unlikely that relevant amounts of pigment additiv RL become systemically bioavailable after oral, dermal or inhalation exposure,

- pigment additiv RL caused no lethality and no adverse systemic or local effects after single oral or dermal application of doses up to 2000 mg/kg bw,

- pigment additiv RL caused no systemic toxic effects in a 28-day oral gavage study in rats (>=NOAEL 1000 mg/kg/day) and there was no evidence of absorption of the substance,

- pigment additiv RL does not have to be classified as skin sensitizing or as skin or eye irritating. In addition pigment additiv RL didn't show cytotoxicity in vitro (AMES-Test) indicating on the whole that its chemical inertness and low solubility largely prevent interaction with living cells and tissues.

Therefore no DNELs for systemic effects have been derived.

Pigment additive RL does not cause irritation, corrosion or sensitization. It is considered unlikely to become bioavailable in the skin and is considered not to cause respiratory tract irritation. No substance specific effects are expected after local exposure, therefore no DNELs for local effects have been derived. Apart from that, relevant occupational exposure limits for inert dusts should be applied.

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

DNELs for the general population have not been derived because pigment additive RL did not cause relevant toxictiy in any test performed according to the information requirements.

In particular

- pigment additiv RL is a chemically unreactive substance,

- pigment additiv RL can be considered insoluble in water and only slightly soluble in n-octanol or fat.

- due to its low solubility, it is unlikely that relevant amounts of pigment additiv RL become systemically bioavailable after oral, dermal or inhalation exposure,

- pigment additiv RL caused no lethality and no adverse systemic or local effects after single oral or dermal application of doses up to 2000 mg/kg bw,

- pigment additiv RL caused no systemic toxic effects in a 28-day oral gavage study in rats (>=NOAEL 1000 mg/kg/day) and there was no evidence of absorption of the substance,

- pigment additiv RL does not have to be classified as skin sensitizing or as skin or eye irritating. In addition pigment additiv RL didn't show cytotoxicity in vitro (AMES-Test) indicating on the whole that its chemical inertness and low solubility largely prevent interaction with living cells and tissues.

Therefore no DNELs for systemic effects have been derived.

Pigment additive RL does not cause irritation, corrosion or sensitization. It is considered unlikely to become bioavailable in the skin and is considered not to cause respiratory tract irritation. No substance specific effects are expected after local exposure, therefore no DNELs for local effects have been derived.