Registration Dossier

Classification & Labelling & PBT assessment

DSD-DPD

General information

Name:
Pyrochlore
Status:
67/548/EEC annex 1
Remarks:
Pyrochlore: The overall chemical and physiological properties of pyrochlore are principally characterised by a degree of inertness because of the specific synthetic process (calcination at high temperatures, approximately 1000°C), rendering the substance to be of a unique, stable crystalline structure in which the majority of atoms are tightly bound and not prone to dissolution in environmental and physiological media. This has been shown in in-vitro bioaccessibility testing for antimony, in which dissolved Sb concentrations were below 105 ug/L even at the highest loading of 0.1g/L, thus implying a solubility of < 0.12% of antimony. Hence, Sb can be considered as not bioavailable and is not regarded concerning toxicological and environmental effects. On the other hand, lead dissolution levels were much higher (up to 6.2 mg/L at pH 1.7) and therefore have to be regarded concerning toxicological and environmental aspects. No substance-specific data on the toxicity of pyrochlore are available, so that instead read-across to lead oxide and sparingly soluble lead compounds was conducted. Lead: Existing classification in accordance with Annex 1 of Directive 67/548/EEC entry "lead compounds with the exception of those specified elsewhere in this Annex". The basis of the original environmental classifications is unknown. However current industry data supports the EU environmental classifications. The basis of the original human health classifications is unknown. However the lead oxide CSR includes a self-classification section that, based on industry’s analysis of current data, WOULD NOT FULLY SUPPORT THE EU CLASSIFICATION. There is limited evidence that this substance has carcinogenic effects and therefore this should be included. There is limited evidence of carcinogenic effect and it is proposed that the R33 is changed to R48/23/25 which was not is not mentioned in the harmonised classification which should be applied. The classification for acute toxicity via oral route and by inhalation could not be approved for the pigment pyrochlore.

Classification

Explosiveness

Reason for no classification:
data conclusive but not sufficient for classification

Oxidising properties

Reason for no classification:
data conclusive but not sufficient for classification

Flammability

Reason for no classification:
data conclusive but not sufficient for classification

Thermal stability

Reason for no classification:
data conclusive but not sufficient for classification

Acute toxicity

Reason for no classification:
data conclusive but not sufficient for classification

Acute toxicity - irreversible damage after single exposure

Reason for no classification:
data conclusive but not sufficient for classification

Repeated dose toxicity

Classification:
R33 Danger of cumulative effects.

Irritation / corrosion

Reason for no classification:
data conclusive but not sufficient for classification

Sensitisation

Reason for no classification:
data conclusive but not sufficient for classification

Carcinogenicity

Classification:
Carc. Cat. 3; R40 Limited evidence of a carcinogenic effect.

Mutagenicity - genetic toxicity

Reason for no classification:
data conclusive but not sufficient for classification

Toxicity to reproduction - fertility

Classification:
Repr. Cat. 3; R62 Possible risk of impaired fertility

Toxicity to reproduction - development

Classification:
Repr. Cat. 1; R61 May cause harm to the unborn child.

Toxicity to reproduction - breastfed babies

Reason for no classification:
data conclusive but not sufficient for classification

Environment

Classification:
N; R50/53 Dangerous for the environment; Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

Labelling

Indication of danger

N - dangerous for the environment
T - toxic

Risk phrases

R33 - Danger of cumulative effects
R40 - Limited evidence of a carcinogenic effect
R50/53 - Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment
R61 - May cause harm to the unborn child
R62 - Possible risk of impaired fertility

Safety phrases

S53 - avoid exposure - obtain special instructions before use
S45 - in case of accident or if you feel unwell, seek medical advice immediately (show the label where possible)
S60 - this material and its container must be disposed of as hazardous waste
S61 - avoid release to the environment. refer to special instructions/safety data sheets

Specific concentration limits

1. Concentration range (%):
>= 2.5
Classification:
Repr. Cat. 3; R62 Possible risk of impaired fertility
2. Concentration range (%):
>= 0.5
Classification:
R33 Danger of cumulative effects.
3. Concentration range (%):
>= 1
Classification:
Xn; R20/22 Harmful by inhalation and if swallowed.

Notes