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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
The test was conducted based upon the Federal Hazardous Substances Act - Consumer Product Safety Commission, 16 CFR, Part 1500, Chapter 2, Subpart C, Section 1500.3, 1990.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: Charles River Breeding laboratories (Wilmington, MA)

- Age at study initiation: 8-12 weeks old

- Weight at study initiation: 200-300 g bw

- Fasting period before study: overnight

- Housing: individually housed using stainless steel cages

- Diet: commercial rodent ration, ad libitum

- Water: municipal tap water, ad libitum

- Acclimation period: 3 day quarantine upon receipt



ENVIRONMENTAL CONDITIONS

- Temperature (°F): 68 +/-3

- Humidity (%): 30-70

- Air changes (per hr): min. 10-13

- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
No data available.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Clinical observations were conducted daily and included all toxicologic and pharmacologic signs including nature, onset, severity and duration of abnormal or unusual cardiovascular, respiratory, excretory, behavioural and other activities, as well as signs including adverse effect on the central nervous system (paralysis, lethargy, lack of coordination and staggering) and time of death. Individual body weights were determined on the fasted animals on day 0 (shortly before the test article was administered) and again on study day 7 and 14.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: A gross necropsy was performed on all animals on day 14.
Statistics:
No statistical analysis performed.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no mortalities.
Clinical signs:
There were no overt signs of toxicity noted in any test animal during the observation period.
Body weight:
All animals exhibited a gain in body weight during the post treatment period.
Gross pathology:
No unusual lesions were noted in any of the animals at necropsy.
Other findings:
None reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
An acute oral LD50 value of >5000 mg/kg for male and female rats was determined in a reliable study conducted according to an appropriate test protocol.