Registration Dossier

Classification & Labelling & PBT assessment

GHS

General Information

Implementation:
EU
Type of classification:
self-classification
Remarks:

A guideline and GLP compliant prenatal development toxicity study identified no effects of FeMn slag on the pregnant rat or on survival or development of foetuses after dosing up to the limit dose of 1000 mg/kg/day.

 

Contrary to the rat prenatal development data, in the rabbit prenatal development study, adverse foetal effects were observed at all dose levels (100, 300 or 800 mg/kg/day), with minor skeletal ossification delays also apparent at 300 or 800 mg/kg/day. In view of the nature and incidence of major fetal abnormalities detected in all treated groups, a NOAEL for embryo-fetal development was not established. However, it should be noted that the morphological changes in foetuses were disparate and without a clear dose-response when the individual incidences of anomalies were considered on a litter or foetal basis. With regard to maternal toxicity, effects were largely comparable to controls at all dose levels, however, clear vehicle tolerability issues were apparent at all dose levels, demonstrated by 5 premature deaths (23 %) in the vehicle (Corn oil; 2 mL/kg dose volume) control group due to gastro-intestinal disturbance, inappetence and embryo-foetal deaths, abortions and/or litter resorptions. Though maternal clinical signs, body weight gains and food intake were comparable to controls in all groups, poor diet consumption reflecting GI disturbance in all groups, including controls, reduces the reliability of these data. Whilst post-implantation loss was marginally increased in females dosed at 800 mg/kg/day, the higher incidence of deaths in the controls which also had marked embryo-foetal deaths has biased these data because the premature decedent data are excluded from the mean values.

 

Based on the above, the registered substance is classified as Category 2 (H361) for developmental toxicity. This reflects the uncertainty in the reliability of the rabbit prenatal evidence, with adverse effects only observed in one species with confounding vehicle effects, and no maternal or developmental effects of prenatal exposure to FeMn slag in the other species.  This is considered to lower the concern for human relevance.

Related composition

Related composition:
Composition 1

Classificationopen allclose all

Explosives
Reason for no classification:
data conclusive but not sufficient for classification
Flammable gases and chemically unstable gases
Reason for no classification:
data conclusive but not sufficient for classification
Aerosols
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
hazard class not assessed
Oxidising gases
Reason for no classification:
data conclusive but not sufficient for classification
Gases under pressure
Reason for no classification:
data conclusive but not sufficient for classification
Flammable liquids
Reason for no classification:
data conclusive but not sufficient for classification
Flammable solids
Reason for no classification:
data conclusive but not sufficient for classification
Self-reactive substances and mixtures
Reason for no classification:
data conclusive but not sufficient for classification
Pyrophoric liquids
Reason for no classification:
data conclusive but not sufficient for classification
Pyrophoric solids
Reason for no classification:
data conclusive but not sufficient for classification
Self-heating substances and mixtures
Reason for no classification:
data conclusive but not sufficient for classification
Substances and mixtures which in contact with water emit flammable gases
Reason for no classification:
data conclusive but not sufficient for classification
Oxidising liquids
Reason for no classification:
data conclusive but not sufficient for classification
Oxidising solids
Reason for no classification:
data conclusive but not sufficient for classification
Organic peroxides
Reason for no classification:
data conclusive but not sufficient for classification
Corrosive to metals
Reason for no classification:
data conclusive but not sufficient for classification
Desensitized explosives
Reason for no classification:
data lacking
Acute toxicity - oral
Reason for no classification:
data conclusive but not sufficient for classification
Acute toxicity - dermal
Reason for no classification:
data conclusive but not sufficient for classification
Acute toxicity - inhalation
Reason for no classification:
data lacking
Skin corrosion / irritation
Reason for no classification:
data conclusive but not sufficient for classification
Serious eye damage / eye irritation
Reason for no classification:
data conclusive but not sufficient for classification
Respiratory sensitisation
Reason for no classification:
data lacking
Skin sensitisation
Reason for no classification:
data conclusive but not sufficient for classification
Aspiration hazard
Reason for no classification:
data lacking
Reproductive toxicity
Hazard category:
Repr. 2
Hazard statement:
H361: Suspected of damaging fertility or the unborn child <state specific effect if known> <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
Route of exposure:
oral
Effects on or via lactation
Reason for no classification:
data lacking
Germ cell mutagenicity
Reason for no classification:
data conclusive but not sufficient for classification
Carcinogenicity
Reason for no classification:
data lacking
1. Specific target organ toxicity - single (STOT-SE)
Reason for no classification:
data conclusive but not sufficient for classification
1. Specific target organ toxicity - repeated (STOT-RE)
Reason for no classification:
data conclusive but not sufficient for classification
Hazardous to the aquatic environment (acute / short-term)
Reason for no classification:
data conclusive but not sufficient for classification
Hazardous to the aquatic environment (long-term)
Reason for no classification:
data conclusive but not sufficient for classification
Hazardous to the ozone layer
Reason for no classification:
data lacking

Labelling

Signal word:
Warning

Hazard pictogram

GHS08: health hazard

Hazard statements

H361d: Suspected of damaging the unborn child.

Precautionary statements

P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P280: Wear protective gloves/protective clothing/eye protection/face protection/hearing protection/...
P308+P313: IF exposed or concerned: Get medical advice/attention.

Notes