Manganese carbonate

GHS

General Information

Name:

Manganese carbonate

Not classified

Implementation:

EU

Remarks:

Reproductive Toxicity

Method	Substance tested	Study title	Laboratory, Author and Year
OECD 416 (Two-Generation Reproduction toxicity study by inhalation route in the rat)	Manganese dichloride (read-across)	Two Generation Reproduction Inhalation Toxicity Study of Manganese Dichloride in Rats	CRL, Grieve L, 2017

A guideline and GLP compliant two generation rat inhalation reproductive toxicity study was conducted with a more efficient provider of soluble manganese ions, namely manganese dichloride. At dose levels showing evidence of tolerable but clear parental toxicity (manifesting as decreased food intake and body weight performance), there was no effect on oestrous cyclicity, mating performance, sexual maturity, fertility or duration of gestation or litter size, the sperm motility or morphology, nor on the formation and maturation of ovarian follicles in either generation. Manganese chloride is therefore not a reprotoxicant, having no effect on sexual function or fertility, or on post-natal development in the rat. Therefore, soluble and insoluble forms of inorganic manganese compounds by extrapolation are considered not reprotoxicants.

 

In addition a literature review by Strupp and Furnes (2009) showed no evidence of reproductive toxicity for manganese carbonate.

 

Hence, there is considered to be no requirement to classify the test material for reproductive toxicity in the absence of data warranting classification.

Developmental Toxicity

Available data from which the C&L is derived:

Method	Substance tested	Study title	Laboratory, Author and Year
Not conducted to a specific guideline	Manganese carbonate	Manganese Carbonate (MnCO3): Combined Pilot Study and Preliminary Embryo-Foetal Development Study in the New Zealand White Rabbit by Oral (Gavage) Administration	Envigo, Stannard D, 2016
OECD 414	Manganese dichloride (read-across)	Manganese dichloride: Prenatal Developmental Toxicity Study in the Han Wistar Rat	Harlan, Dettwiler M, 2014

Developmental toxicity data in the rat on the read-across substance manganese dichloride has no classification for developmental toxicity.

 

In rabbits, the pilot study was conducted because there was no literature available relating to the potential effects of manganese exposure in this species. It identified exposure up to the limit dose of 1000 mg / kg / day in non-pregnant rabbits was generally well tolerated for 14 days.

 

The preliminary study identified clear embryo-foetal toxicity at dose levels ≥ 150 mg/kg/day (decreased embryo-foetal survival) but only in the presence of overt, excessive maternal toxicity which manifested as premature mortality, with an associated decline in clinical condition, body weight loss and inappetence (150 mg/kg/day was associated with maternal mortality of 50 %). ECHA CLP guidance (see reference below: Annex I: 3.7.2.4.4) defines that 'maternal mortality greater than 10 % is considered excessive and the data from that dose level shall not normally be considered further for evaluation'.

 

Hence, it is justified to consider that although identifying findings of concern in a limited data set, the preliminary study does not provide sufficient data for basis of classification owing to the excessive maternal toxicity apparent at all dose levels where embryo-foetal effects are apparent. In order to clarify this concern it is recommended that a full OECD Guideline 414 study is conducted in the rabbit. This would allow a conclusion on the appropriate C&L to be reached.

 

Reference: Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures Version 5.0 July 2017, ECHA.

Related composition

Related composition:

Manganese carbonate

Classification

Physical hazards

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

Health hazards

Acute toxicity - oral

Reason for no classification:

data conclusive but not sufficient for classification

Acute toxicity - dermal

Reason for no classification:

data lacking

Acute toxicity - inhalation

Reason for no classification:

data conclusive but not sufficient for classification

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

Reason for no classification:

data conclusive but not sufficient for classification

Route of exposure:

inhalation

Effects on or via lactation

Reason for no classification:

data conclusive but not sufficient for classification

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

Environmental hazards

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:

No signal word