Registration Dossier
Registration Dossier
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EC number: 936-276-2 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- adverse effect observed
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Short description of key information:
The critical constituents (lead compounds) in the target substance
in Annex VI of CLP1272/2008 have harmonized classification entry (Repr
1A H360Df). The available data from human epidemiological studies on
lead compounds indicate that lead exposure is associated with
disturbances of endocrine and reproductive functions in men and
pregnancy outcome. Animal studies have served causality in epidemiology
studies and to elucidate potential mechanisms of action.
Based on the composition of the target substance and on the fact that
exposure to inorganic lead compounds has been documented to result
adverse effects on human fertility the target UVCB substance needs to be
classified for Repr 1A through inhalation and if swallowed. Dermal route
is not relevant route of human exposure, since dermal absorption of lead
compounds through intact skin is expected < 0.1%.
Justification for selection of Effect on fertility via oral route:
No study conducted for the target UVCB substance. The hazard
assessment conclusion is based on the overall weight of evidence of the
results of several fertility studies conducted for the most critical
constituents in the target substance i.e. lead and zinc compounds.
Justification for selection of Effect on fertility via inhalation
route:
No inhalation studies available for the target substance itself or
the most critical constituents in the target substance i.e. lead and
zinc compounds.
Justification for selection of Effect on fertility via dermal route:
No dermal studies available for the target substance itself or the
most critical constituents in the target substance i.e. lead and zinc
compounds.
Effects on developmental toxicity
Description of key information
The critical constituents (lead compounds) in the target substance in Annex VI of CLP1272/2008 have harmonized classification entry
(Repr 1A). The available data from human epidemiological studies on lead compounds indicate that lead exposure is associated with disturbances of endocrine and reproductive functions in men and pregnancy outcome. Animal studies have served causality in epidemiology studies and to elucidate potential mechanisms of action.
Based on the composition of the target substance and on the fact that exposure to inorganic lead compounds has been documented to
result adverse effects on neurobehavioral development in children the target UVCB substance needs to be classified for Repr 1A H360Df
through inhalation and if swallowed. Dermal route is not relevant route of human exposure, since dermal absorption of lead compounds through intact skin is expected < 0.1%.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Justification for selection of Effect on developmental toxicity: via
oral route:
No study conducted for the target UVCB substance. The hazard
assessment conclusion is based on the overall weight of evidence of the
results of several developmental toxicity studies conducted for the most
critical constituents in the target substance i.e. lead and zinc
compounds.
Justification for selection of Effect on developmental toxicity: via
inhalation route:
No inhalation studies available for the target substance itself or
the most critical constituents in the target substance i.e. lead and
zinc compounds.
Justification for selection of Effect on developmental toxicity: via
dermal route:
No dermal studies available for the target substance itself or the
most critical constituents in the target substance i.e. lead and zinc
compounds.
Justification for classification or non-classification
According to the transformation/dissolution study (OECD guidance 29) conducted for the substance, the most critical constituents leachable to water from this UVCB substance are lead and zinc compounds. Lead compounds in Annex VI of Regulation (EC) No 1272/2008 (CLP) has harmonized classification for Repr. 1A H360Df and for Repr. Cat. 3; R62 according to EU Directive 67/548/EEC. Thus, according to the CLP mixture rules also the target UVCB substance is classified to this hazard class.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
