Registration Dossier
Registration Dossier
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EC number: 250-001-7 | CAS number: 30007-47-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
- Reference Type:
- publication
- Title:
- Bronidox, a new preserving agent for the cosmetics: properties and toxicological-dermatological assays
- Author:
- M. Potokar, et al.
- Year:
- 1 976
- Bibliographic source:
- Fette, Seifen, Anstrichmittel, Jahrgang 78, Nr. 7, 269-276
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 977
- Reference Type:
- publication
- Title:
- Final Report on the Safety Assessment of 5-Bromo-5-Nitro-1,3-Dioxane
- Author:
- Anonymous (Cosmetic Ingredient Review 10)
- Year:
- 1 990
- Bibliographic source:
- Journal of the American College of Toxicology, Volume 9, Number 2
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 5-bromo-5-nitro-1,3-dioxane
- EC Number:
- 250-001-7
- EC Name:
- 5-bromo-5-nitro-1,3-dioxane
- Cas Number:
- 30007-47-7
- Molecular formula:
- C4H6BrNO4
- IUPAC Name:
- 5-bromo-5-nitro-1,3-dioxane
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 174 g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Remarks:
- solution was heated a little bit
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: Injection volume 30 cm3/kg
- Doses:
- 100, 251, 316, 398, 501, 631, 794, 713, 754 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Not determined
- Necropsy of survivors performed: No
- Other examinations performed: Clinical signs
Results and discussion
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 455 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 251 mg/kg bw: 1/ 10
316 mg/kg bw: 3/ 10
398 mg/kg bw: 4/ 10
501 mg/kg bw: 5/ 10
631 mg/kg bw: 6/ 10
713 mg/kg bw: 8/ 10
754 mg/kg bw: 9/ 10 - Clinical signs:
- other: at 100 mg/kg bw: cutting and accelerated breathing, staggering, after 2 days extreme nerve symptoms (agitation, shaking, rotary motion)
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
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