Registration Dossier
Registration Dossier
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EC number: 229-347-8 | CAS number: 6484-52-2
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The report was very limited documented, although the analytical part was more extensive. Also limited parameters were observed.
Data source
Reference
- Reference Type:
- publication
- Title:
- Ammonia nitrate inhalation test on rats
- Author:
- KemaMord
- Year:
- 1 978
- Bibliographic source:
- Research Institute of Swedish National Defense (FOA) and the National Veterinary Institute (SVA), Stockholm, Sweden (cited in European Commission 2000).
Materials and methods
- Principles of method if other than guideline:
- No data
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Ammonium nitrate
- EC Number:
- 229-347-8
- EC Name:
- Ammonium nitrate
- Cas Number:
- 6484-52-2
- Molecular formula:
- H3N.HNO3
- IUPAC Name:
- ammonium nitrate
- Test material form:
- solid
- Remarks:
- crystals or granules
- Details on test material:
- ammonium nitrate dust collected from filters used in the ventilation unit at the KemaNord ammonium nitrate factory at Ljungaverk
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- other: no data
- Remarks on MMAD:
- MMAD / GSD: particles < 5 microm. = between 26 and 50 wt%.
30% of the particles were < 10 micrometer - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 2 weeks
- Frequency of treatment:
- 5 hrs/day; 5 days/week
Doses / concentrations
- Dose / conc.:
- 185 mg/m³ air (analytical)
- Remarks:
- Maximum dose
Minimum dose: 26 mg/m^3 air
- No. of animals per sex per dose:
- 10 animals were exposed to ammonium nitrate
- Control animals:
- other: yes, 5 control animals were exposed to an air current, 5 control animals were totally untreated.
Examinations
- Observations and examinations performed and frequency:
- Bodyweights were registered before, during and after exposure.
- Sacrifice and pathology:
- After killing, autopsy was carried out and organs were taken for histopathological analysis.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
Effect levels
- Key result
- Dose descriptor:
- NOAEC
- Remarks:
- systemic
- Effect level:
- >= 185 mg/m³ air
- Sex:
- male
- Basis for effect level:
- other: No effects observed.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
A certain irritation in the nostrils of the test group was seen, no further symptoms. However, it was not clear at which concentrations these effects were seen. No significant differences in body weight between test and control animals. No macroscopically or microscopically effects have been seen. Post exposure observation period: 3 days
Applicant's summary and conclusion
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