5-bromo-5-nitro-1,3-dioxane

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

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Reference 2

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 3

Reference Type:

publication

Title:

Unnamed

Year:

1977

Reference 4

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

Test material information

Constituent 1

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:

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