Registration Dossier
Registration Dossier
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EC number: 232-164-6 | CAS number: 7789-41-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
Read across from NaBr to CaBr2 is possible due to the full dissociation of both compounds in water. Na+ and Ca2+ are not toxic in the concentration ranges where Br- is toxic. Therefore only the Br- is responsible for the toxicity effects.
Sodium bromide reproductive toxicity in the rat – Fertility was nil in the 19200 ppm group and was markedly reduced in the 4800 ppm group. These effects were found to be reversible. In the latter group, the viability of the offspring was lower than in the other groups. Microscopic examinations of all pups born during the entire experimental period provided no evidence of anomalies. The lowest LO(A)EL was for female parental toxicity at 1200 ppm NaBr in feed (dose related effects on female adrenal weights first become significant at this dose).NOAEL is 300 ppm in feed.
Short description of key information:
Toxicity of Sodium Bromide in Rats: Effects on Endocrine System and Reproduction
Sodium Bromide - Developmental Toxicity (Embryofoetal Toxicity and Teratogenic Potential) Study in Rats (Gavage Administration)
Sodium bromide: Oral gavage pre-natal developmental toxicity study in the rabbit
Effects on developmental toxicity
Additional information
Read across from NaBr to CaBr2 is possible due to the full dissociation of both compounds in water. Na+ and Ca2+ are not toxic in the concentration ranges where Br- is toxic. Therefore only the Br- is responsible for the toxicity effects.
Sodium bromide developmental toxicity in the rat.
LOAEL: 300 mg/kg bw/day based reduced body weight gains in dams and foetal skeletal anomalies and variants (equivalent to 233 mg (Br-)/kg bw/day)
NOAEL: 100 mg/kg bw/day (equivalent to 77.6 mg (Br-) /kg bw/day)
Justification for classification or non-classification
The NOEL for tertogenic effects with sodium bromide is 250 mg/kg bw/day, comparable to the NOAEL for maternal toxicity (250 mg/kg bw/day). Therefore, sodium bromide should not be classified under reproduction as a developmental toxicant, based on effects secondary to maternal toxicity.
Additional information
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