Registration Dossier

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

Discussion

The conclusions are based on the recommendations of the ECHA "Guidance on information requirements and chemical safety assessment – Chapter R.8: Characterisation of dose [concentration]-response for human health" (November 2012) and onthe "Guidance on information requirements and chemical safety assessment - Part B: Hazard assessment".

In the absence of any relevant toxic effect in the toxicological studies performed with iron oxide isostearate and with its analogues cerium and iron oxide isostearate (Acitve mater of DPX10 and Active matter of DPX11) leading to Classification & Labelling, no specific DNEL was derived:

- oral and dermal DL50 > 2000 mg/kg bw/d (by analogy with cerium and iron oxide isostearate, Active matter of DPX10)

- absence of irritation effects (by analogy with cerium and iron oxide isostearate (Active matter of DPX10 - Ce:Fe ratio 0.5:0.5) and/or cerium and iron oxide isostearate (Active matter of DPX11- Ce:Fe ratio 0.1:0.9).

- absence of skin sensitisation (result on the target substance and also by analogy with cerium and iron oxide isostearate, Active matter of DPX10 and DPX11)

- no genotoxic effects (result on the target substance and also by analogy with cerium and iron oxide isostearate, Active matter of DPX10 and DPX11)

-absence of any relevant signs of toxicity observed up to the limit dose of 1000 mg/kg bw/d (OECD TG 407 and OECD 416) (by analogy with cerium and iron oxide isostearate Active matter of DPX10)

It is in accordance with the "Guidance on information requirements and chemical safety assessment - Part B: Hazard assessment" (chapter B.8.4, page 48), where it is indicated that if no adverse effects have been observed in studies at the highest recommended concentrations/doses tested, this would normally indicate that no hazard has been identified and no DNEL need to be derived.

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

Discussion

The conclusions are based on the recommendations of the ECHA "Guidance on information requirements and chemical safety assessment – Chapter R.8: Characterisation of dose [concentration]-response for human health" (November 2012) and onthe "Guidance on information requirements and chemical safety assessment - Part B: Hazard assessment".

In the absence of any relevant toxic effect in the toxicological studies performed with iron oxide isostearate andwith its analogues cerium and iron oxide isostearate (Acitve mater of DPX10 and Active matter of DPX11)leading to Classification & Labelling, no specific DNEL was derived:

- oral and dermal DL50 > 2000 mg/kg bw/d(by analogy with cerium and iron oxide isostearate (Active matter of DPX10 - Ce:Fe ratio 0.5:0.5) and/or cerium and iron oxide isostearate (Active matter of DPX11- Ce:Fe ratio 0.1:0.9).

- absence of irritation effects(by analogy with cerium and iron oxide isostearate, Active matter of DPX10)

- absence of skin sensitisation(result on the target substance and also by analogy with cerium and iron oxide isostearate, Active matter of DPX10 and DPX11)

- no genotoxic effects(result on the target substance and also by analogy with cerium and iron oxide isostearate, Active matter of DPX10 and DPX11)

-absence of any relevant signs of toxicity observed up to the limit dose of 1000 mg/kg bw/d (OECD TG 407 and OECD 416) (by analogy with cerium and iron oxide isostearate Active matter of DPX10)

It is in accordance with the "Guidance on information requirements and chemical safety assessment - Part B: Hazard assessment" (chapter B.8.4, page 48), where it is indicated that if no adverse effects have been observed in studies at the highest recommended concentrations/doses tested, this would normally indicate that no hazard has been identified and no DNEL need to be derived.