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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: similar to OECD-guideline, non-GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): rosenoxid-D
- Physical state: colourless liquid
- Analytical purity: no analytical data on test material, probably technically pure substance was tested
- Lot/batch No.: 22356

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
200, 2000 mg/kg bw
No. of animals per sex per dose:
2000 mg/kg: 5
200 mg/kg: 3
Control animals:
other: not applicable
Details on study design:
Following administration in both cases, observations were made and recorded systemically with individual records being maintained for each animal. Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after the administration. All surviving animals were observed. During the 14-day follow-up period, changes of skin and fur, eyes and mucous membranes, respiratory and circulatory functions, autonomic and central nervous system, somatomotor activity as well as behavioural pattern were observed at least once a day until all symptoms had subsided, thereafter each working day. Attention was also paid to possible tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. Individual body weights were recorded before administration of the substance and thereafter in weekly intervals up to the end of the study and – when necessary – at death. Changes in weight were calculated when survival exceeded one day. At the end of the experiment, all surviving animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes were recorded. From animals which survived 24 hours or longer, a microscopic examination of all organs which showed evident lesions was performed, if necessary. Necropsy and macroscopic inspection of animals that died prematurely would be performed as soon as possible after exitus.
Statistics:
no data

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality observed for males
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 4 735 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 1/5 female rat died within 7 days
Sex:
male/female
Dose descriptor:
LD50
Effect level:
10 225 mg/kg bw
Mortality:
200 mg/kg: no mortality
2000 mg/kg: 1/5 female animals died within 7 days
Clinical signs:
No adverse effects observed
Body weight:
No adverse effects observed
Gross pathology:
No abnormalities observed

Applicant's summary and conclusion

Executive summary:

The aim of the present study was to identify the acute oral toxicity of Rosenoxid-D. Under the present test conditions, a single oral administration of 2000 mg Rosenoxid-D/kg b.w. to rats caused mortality in one of five female animals. A dose of 200 mg Rosenoxid-D/kg b.w. to rats revealed neither toxic symptoms nor mortality. In both concentrations, the animals gained the expected weight through the test exposure period and no abnormalities were noted during necropsy. Therefore, LD50 is higher than 2000 mg/kg bw for male animals and 4735 mg/kg bw for female animals.