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EC number: 231-554-3
CAS number: 7631-99-4
A reliable LLNA study showed no sensitisation of sodium nitrate.
Tables and figures have been included in the attached document "LLNA tables and figures".
Initially, three groups of five animals were
treated with one test substance concentration per group. The highest
test substance concentration was selected from the preliminary
irritation study. One group of five animals was treated with vehicle and
another group of five animals was treated with the positive control
substance. Since the DPM values for control animals were generally well
below the range expected, the study was considered invalid. The results
of that study are not reported; all data are retained in the study
records. The study was therefore repeated with the same concentrations,
including a vehicle and positive control group.
Other results: Main study:
No irritation of
the ears was observed in any of the animals treated with the test
substance or vehicle. Slight to well defined erythema was observed on
both ears of all animals treated with the positive control substance,
which was considered not to have a toxicologically significant effect on
the activity of the nodes. No oedema was observed in any of the animals
examined. No macroscopic
abnormalities of the surrounding area were noted in any of the animals.
Body weights and body weight gain of experimental animals remained in
the same range as controls over the study period. The slight body weight
loss, noted in some animals, was considered not toxicologically
significant. No mortality occurred and no symptoms of systemic toxicity
were observed in the animals of the main study.
Preliminary irritation study:
No irritation and no signs of systemic
toxicity were observed in any of the animals examined. Based on these
results, the highest test substance concentration selected for the main
study was a 50% concentration.
See also Table 1 in the attached document LLNA tables and figures
In a reliable skin sensitisation study, the LLNA test, performed
according to OECD 429, EC B42 and EPA guidelines, sodium nitrate does
not show sensitising properties.
Justification for selection of skin sensitisation endpoint:
One LLNA study on the substance is available.
According to Annex I of Regulation (EC) No. 1272/2008 sodium nitrate is
not classified for skin sensitisation based on the absence of positive
effects in an animal study.
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.
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