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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Comparison of hypotensive action of sodium azide in normotensive and hypertensive patients
Author:
Blak M.M. et al.
Year:
1954
Bibliographic source:
Proc Soc Exp Biol Med. 85(1):11-6, PMID: 13134274
Reference Type:
review article or handbook
Title:
Weight of Evidence Discussion for Sodium Azide (NaN3)
Author:
Mc Carroll N.
Year:
2007
Bibliographic source:
US Environmental Protection Agency (EPA) Memorandum TXR 0054719

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
repeated dose toxicity: oral
Test guideline
Qualifier:
no guideline required
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium azide
EC Number:
247-852-1
EC Name:
Sodium azide
Cas Number:
26628-22-8
Molecular formula:
N3Na
IUPAC Name:
sodium azide

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 30 hypertensive patients plus 9 normotensive controls
- Sex: not reported
- Age: no data
- Race: no data
- Demographic information: no data
- Known diseases: hypertension (patients)
Ethical approval:
not specified
Route of exposure:
oral
Reason of exposure:
intentional
Details on exposure:
0.65-1.3 mg sodium azide solved in water at least 3 times a day

Results and discussion

Clinical signs:
The 30 hypertensive patients showed following signs: 5 cases showed minimal changes in blood pressure; 10 exhibited a significant fall in systolic blood pressure but the diastolic pressure remained above 100 mm Hg; and 15 had persistent blood pressure levels near normal and 3 patients, who were checked for clinical signs, showed no evidence of damage to kidneys, heart, or liver and no changes in bowel habits or urinary function after 1 year.
Administration of a comparable dose 3 times per day to 9 normotensive individuals (total daily dose = 0.06 mg/kg, based on a 70-kg adult) for 10 days had no sustained effect on blood pressure.
Effectivity of medical treatment:
Data show that an acute total dose as low as 0.65 mg (0.01 mg/kg, based on a 70-kg adult) had a hypotensive effect on patients with high blood pressure while a total dose of 1.3 mg (0.02 mg/kg, based on a 70-kg adult) had no adverse effects on normotensive individuals.
Chronic treatment with 1.3 mg sodium azide 3 times a day for ten days had no sustained effect on the blood pressure of normotensive individuals. The same treatment on hypertensive patients (period ranging from 5 days to 2.5 years) resulted in a markedly reduction of blood pressure.

Applicant's summary and conclusion

Conclusions:
Based on the above information, a NOAEL for sodium azide in hypertensive individuals could not be established; however, NOAEL values of 0.02 and 0.06 mg/kg for acute and chronic oral uptake by normotensive individuals were determined.
Executive summary:

In the study conducted by Black et al., a comparison was made between the effects of Sodium azide in both normotensive and hypertensive patients. Doses of 0.01 - 0.02 mg/kg bw, administered orally as aqueous solution, had a rapid hypotensive effect which persisted from 10 - 15 minutes. When given chronically to hypertensives (0.01 -0.02 mg/kg bw at 3 -4 times daily; total dose: 0.03 - 0.08 mg/kg bw/day) for periods up to 2 years, sodium azide produced a sustained lowering of the blood pressure toward normotensive levels. The observations indicate that diffierences exists in the relative sensitivity of hypertensive and normotensive individuals to the hypotensive effects of Sodium azide.

Based on the above information, a NOAEL for sodium azide in hypertensive individuals could not be established; however, NOAEL values of 0.02 and 0.06 mg/kg for acute and chronic oral uptake by normotensive individuals were determined.