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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983-10-05 to 1983-11-30
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions. Only aggregate animal data was reported.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPP 81-1 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown, PA, USA
- Age at study initiation: not stated
- Weight at study initiation: 200 - 300 g
5 rats per cage by sex, stainless steel with elevated wire mesh flooring.
temperature - 65 - 73 degrees F, 45 - 55% humidity, 12 hr ligh/dark photoperiod. Ad libitum rodent diet & tap water.
Rats acclimated prior to dosing and fasted overnight (food only) before dosing

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50% w/v
Doses:
5000 mg/kg
No. of animals per sex per dose:
5 per sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations - frequently on day of dosing and 2x day thereafter. Weighing - individual weights recorded on day of dosing and average group weights recorded on Days 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no mortalities during the study.
Clinical signs:
All animals appeared normal throughout the 14 -day observation period.
Body weight:
See table below.
Gross pathology:
No gross abnormalities were observed for the animals necropised at the conclusion of the study.
Other findings:
No other findings reported.

Any other information on results incl. tables

Average Body weights:

 

Male (g)

Female (g)

Initial

232

211

Day 7

292

237

Day 14

334

247

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 > 5000 mg/kg. The test material is not classified in accordance with Regulation (EC) No. 1272/2008 based on studies in rats.
Executive summary:

Test Guidance

In a study similar to US EPA OPP 81 -1 the test chemical was subjected to oral toxicity testing in rats of both sexes by oral gavage dosing.

Results

All animals appeared normal throughout the 14 -day observation period. No gross abnormalities were observed for the animals necropised at the conclusion of the study. The LD50 for this study is >5000 mg/kg.

Conclusion

The test material is not classified in accordance with Regulation (EC) No. 1272/2008 based on studies in rats.