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Key value for chemical safety assessment

Effects on fertility

Description of key information

There is no indication for fertility risks caused by barium chloride based on the results of the extended one generation study in rats in which a NOAEL of 30 mg/kg/day was derived.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
30 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
The study is fully acceptable
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

In a GLP compliant Extended One Generation Study performed according to OECD 443, Barium dichloride dihydrate was adminstered daily by oral gavage to Sprague-Dawley rats at dose levels of 0, 3, 10 and 30 mg/kg bw/day. No treatment-related changes were observed in reproductive and developmental parameters in Parental generation and for general toxicity in Cohorts 1A and 1B at any of the dose levels investigated. For this reason the dosage of 30 mg/kg/day was considered the NOAEL for general and reproductive toxicity and pups development in Parental generation and for general toxicity in Cohorts 1A and 1B.

Effects on developmental toxicity

Description of key information
Developmental toxicity: a NOAEL of 85.3 mg BaCl2/kg was derived in an oral developmental toxicity study according to OECD 414.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
85.3 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
The study is fully acceptable
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

Developmental toxicity of barium chloride dihydrate was evaluated in a recent prenatal developmental toxicity study by daily administration of the test item at dose levels of 0, 10, 30 or 100 mg BaCl2 * 2 H2O/kg body weight to pregnant rats from gestation day 1 up to and including gestation day 20. No effects on body weights, food consumption and clinical signs were observed. Maternal toxicity was evidenced by the spontaneous deaths of two animals on gestation day 21 only and the conditional decline of another animal on gestation day 21 in the high dose group (100 mg BaCl2 * 2 H2O/kg bw).

No developmental toxicity or treatment-related observations, whatsoever in external, visceral and skeletal foetal examinations were observed in any dose level. The NOAEL for maternal toxicity was therefore 30 mg/kg body weight barium chloride dihydrate (25.6 mg/kg bw barium chloride). In absence of developmental effects, the NOAEL for prenatal developmental toxicity in the rat was ≥ 100 mg/kg body weight barium chloride dihydrate (≥85.3 mg/kg bw barium chloride).

Furthermore, tentative NOAEL values for developmental toxicity of 4,000 ppm and 2,000 ppm for rats and mice, respectively, are also reported in the study by Dietz et al. (1992). However, these NOAELs are of limited value to evaluate the potential for barium to induce developmental effects because the study design did not include prenatal exposure of the female animals to barium dichloride dihydrate. Therefore, this study has to be considered as inadequate for the assessment of the potential to induce developmental toxicity and cannot be used in a regulatory context.

Justification for classification or non-classification

In accordance to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification is not necessary for effects on fertility and development.

Additional information