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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
Study period:
June-July 1969
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: meets basic scientific principles, well documented information

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report Date:
1969

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: commercial breeder (SPF)
- Weight at study initiation: 112.5 (104-121) g
- Fasting period before study: no
- Housing: single in MACROLON cages Type III
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous suspension in 0.5 % carboxymethylcellulose
Details on oral exposure:
Given orally by way of an esophageal tube, in the form of a 16 - 32% aqueous suspension in 0.5% carboxymethyl cellulose.
Doses:
1600, 3200, 6400, 12800 mg/kg
No. of animals per sex per dose:
ten (5 males, 5 females)
Total number of animals: forty (20 males, 20 females)
Control animals:
not specified
Details on study design:
40 rats (20 females, 20 males) were orally exposed at dose levels of 1600, 3200, 6400, 12800 mg/kg. Observations were recorded after 1, 7, 14 days observation period.
Statistics:
standard statistical methods

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 12 800 mg/kg bw
Based on:
test mat.
Mortality:
All the animals survived the 14-day observation period.
Clinical signs:
Most of the test animals exhibited sluggishness and/or slept for up to one hour following the application of the substance .Thereafter, no further changes were noted in the general condition and behavior of the animals.
Body weight:
There is no abnormal observation in the body weight during the test.
Gross pathology:
One animal presented atelectasis of one of the lung lobes. All the other animals were unremarkable.
Other findings:
no data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In conclusion, LD50 after 1, 7 and 14 days of observation was in excess of 12,800 mg/kg in rats by orally.
Executive summary:

Total 40 Wistar rats were exposed test article by orally at dose levels of 1600, 3200, 6400, 12800 mg/kg to assess the potential of acute toxicity. All the animals survived the 14-day observation period. There were no abnormal observations in the body weight during the test. Most of the test animals exhibited sluggishness and/or slept for up to one hour following the application of the substance .And no further changes were noted in the general condition and behavior of the animals.One animal presented atelectasis of one of the lung lobes. All the other animals were unremarkable.

Based on the results, it can be concluded that LD50 of test article was greater than 12800 mg/kg after 1, 7 and 14 days of observation.