Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test method equivalent to EU method B.1 bis. GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid.
Details on test material:
- Name of test material (as cited in study report): OS-2200 (489-95A).
- Physical state: Clear to light yellow liquid.
- Analytical purity: >92%.
- Lot/batch No.: 38659-14.
- Expiration date of the lot/batch: 1 January 1996.
- Storage condition of test material: Room temperature in dark under nitrogen.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Fasting period before study: Yes.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
2000 mg/kg body weight.
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: Observations for clinical signs were made twice daily. Body weights were recorded on day 1 (prior to dosing), 2, 3, 4, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopical observations, clinical signs, body weights.
Statistics:
The LD50 value, and where possible, the value of males and females separately, was calculated from the observed mortality data, using established procedures.

Results and discussion

Preliminary study:
The main test is a limit test, performed at a concentration of 2000 mg/kg body weight.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
Clinical signs of toxicity included abnormal gait, lethargy, decreased respiratory rate, increased salivation, pallor of the extremities, blue color to the skin and extremities, cold body surfaces and prostration seen in all or the majority of the rats. These signs were transient with all animals appearing normal by day 6 post dosing.
Body weight:
Minor transient fluctuations in bodyweight.
Gross pathology:
No remarkable observations.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results, the oral DL50 for the test substance in rat is greater than 2000 mg/kg body weight.
Executive summary:

An acute oral toxicity study was performed with a method equivalent to EU method B.1 bis under GLP conditions. A group of ten rats (5 males and 5 females) was exposed to the test substance in single oral dose by gavage at a dose level of 2000 mg/ kg body weight. Animals were observed for 14 days and then sacrificed and examined macroscopically. No deaths occurred, clinical signs of toxicity observed included abnormal gait, lethargy, decreased respiratory rate, increased salivation, pallor of the extremities, blue color to the skin and extremities, cold body surfaces and prostration seen in all or the majority of the rats. These signs were transient with all animals appearing normal by day 6 post dosing. There were also minor fluctuations in body weights. Based on the results the oral LD50 for the test substance in rat is greater than 2000 mg/kg body weight.