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Toxicological information

Acute Toxicity: oral

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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:
1972
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:
1976
Bibliographic source:
Fette, Seifen, Anstrichmittel, Jahrgang 78, Nr. 7, 269-276
Reference Type:
publication
Title:
Unnamed
Year:
1977
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:
1990
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

Constituent 1
Chemical structure
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

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:
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